A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure (BaxDuo-Pacific)

April 29, 2026 updated by: AstraZeneca

A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants With Chronic Kidney Disease and High Blood Pressure

International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure

Study Overview

Status

Recruiting

Conditions

Chronic Kidney Disease and Hypertension

Intervention / Treatment

Detailed Description

The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, HF events, or CV death in participants with CKD and HTN.

This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin.

Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months.

The study closure procedures will be initiated when the predetermined number of primary endpoint events is predicted to have occurred (N = 845) ie, the PACD. All randomised participants including any participants who have prematurely discontinued study intervention will be scheduled for a SCV within 6 weeks of the PACD. This period can be extended by AstraZeneca.

In case of premature discontinuation of blinded study intervention, participants will continue in the study and receive dapagliflozin 10 mg, unless the participant meets dapagliflozin specific discontinuation criteria. Baxdrostat/placebo should not be administered without dapagliflozin: baxdrostat/placebo should be interrupted if dapagliflozin is interrupted (baxdrostat/placebo may be resumed with dapagliflozin, if dapagliflozin is resumed), and should be permanently discontinued if dapagliflozin is permanently discontinued. If study intervention is temporarily or permanently discontinued, the participant should remain in the study, and it is important that the scheduled study visits (including the PTDV for participants with permanent discontinuation of study intervention) and data collection continue according to the study protocol until the SCV.

Study Type

Interventional

Enrollment (Estimated)

5000

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Argentina
- - CABA, Argentina, C1426
    - Recruiting
    - Research Site
  - CABA, Argentina, C1426
    - Withdrawn
    - Research Site
  - Ciudad Autonoma de Bs As, Argentina, C1023AAB
    - Recruiting
    - Research Site
  - Ciudad de Buenos Aires, Argentina, C1019ABS
    - Recruiting
    - Research Site
  - Ciudad de Buenos Aires, Argentina, C1425AGC
    - Recruiting
    - Research Site
  - Córdoba, Argentina, X5003DCE
    - Recruiting
    - Research Site
  - Córdoba, Argentina, X5016LIG
    - Recruiting
    - Research Site
  - Córdoba, Argentina, 5000
    - Recruiting
    - Research Site
  - Córdoba, Argentina, 5000
    - Withdrawn
    - Research Site
  - Córdoba, Argentina, X5002HWE
    - Recruiting
    - Research Site
  - Córdoba, Argentina, X5006CBI
    - Recruiting
    - Research Site
  - La Plata, Argentina, B1900AVG
    - Recruiting
    - Research Site
  - Lanus, Argentina, 1824
    - Recruiting
    - Research Site
  - Lanús Este, Argentina, B1824KAJ
    - Recruiting
    - Research Site
  - Mar del Plata, Argentina, 7600
    - Recruiting
    - Research Site
  - Mar del Plata, Argentina, B7600
    - Recruiting
    - Research Site
  - Rosario, Argentina, 2000
    - Recruiting
    - Research Site
  - San Nicolás, Argentina, B2900DMH
    - Recruiting
    - Research Site
  - Santa Fe, Argentina, S3000FWO
    - Recruiting
    - Research Site
  - Santiago del Estero, Argentina, 4200
    - Recruiting
    - Research Site
  - Temperley, Argentina, 1834
    - Withdrawn
    - Research Site
  - Temperley, Argentina, CP1834
    - Recruiting
    - Research Site
Australia
- - Adelaide, Australia, 5000
    - Recruiting
    - Research Site
  - Darlinghurst, Australia, 2010
    - Recruiting
    - Research Site
  - Elizabeth Vale, Australia, 5112
    - Recruiting
    - Research Site
  - Gosford, Australia, 2250
    - Recruiting
    - Research Site
  - North Tamworth, Australia, 2340
    - Not yet recruiting
    - Research Site
  - Perth, Australia, 6000
    - Recruiting
    - Research Site
  - Southport, Australia, 4215
    - Recruiting
    - Research Site
  - St Leonards, Australia, 2065
    - Recruiting
    - Research Site
  - Wollongong, Australia, 2500
    - Recruiting
    - Research Site
Belgium
- - Aalst, Belgium, 9300
    - Recruiting
    - Research Site
  - Brussels, Belgium, 1200
    - Recruiting
    - Research Site
  - Genk, Belgium, 3600
    - Recruiting
    - Research Site
  - Hasselt, Belgium, 3500
    - Recruiting
    - Research Site
  - Ieper, Belgium, 8900
    - Recruiting
    - Research Site
  - Jette, Belgium, 1090
    - Recruiting
    - Research Site
  - Kortrijk, Belgium, 8500
    - Recruiting
    - Research Site
  - Leuven, Belgium, 3000
    - Recruiting
    - Research Site
  - Liège, Belgium, 4000
    - Recruiting
    - Research Site
  - Mechelen, Belgium, 2800
    - Recruiting
    - Research Site
  - Namur, Belgium, 5000
    - Recruiting
    - Research Site
  - Roeselare, Belgium, 8800
    - Recruiting
    - Research Site
  - Ronse, Belgium, 9600
    - Recruiting
    - Research Site
  - Sint-Truiden, Belgium, 3800
    - Withdrawn
    - Research Site
Brazil
- - Barretos, Brazil, 14784-400
    - Recruiting
    - Research Site
  - Belém, Brazil, 66073-005
    - Recruiting
    - Research Site
  - Brasília, Brazil, 70200-730
    - Recruiting
    - Research Site
  - Campina Grande do Sul, Brazil, 83.430-000
    - Recruiting
    - Research Site
  - Campinas, Brazil, 13060-080
    - Recruiting
    - Research Site
  - Campinas, Brazil, 13060-904
    - Recruiting
    - Research Site
  - Curitiba, Brazil, 80230-130
    - Recruiting
    - Research Site
  - Fortaleza, Brazil, 60175-047
    - Recruiting
    - Research Site
  - Joinville, Brazil, 89227-680
    - Recruiting
    - Research Site
  - Natal, Brazil, 59020-035
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90160-093
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90020-090
    - Recruiting
    - Research Site
  - Rio de Janeiro, Brazil, 20241-180
    - Recruiting
    - Research Site
  - São José do Rio Preto, Brazil, 15090-000
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 04038-031
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 04012-180
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 05403-9000
    - Recruiting
    - Research Site
Bulgaria
- - Byala, Bulgaria, 7100
    - Recruiting
    - Research Site
  - Dupnitsa, Bulgaria, 2600
    - Recruiting
    - Research Site
  - Gabrovo, Bulgaria, 5300
    - Recruiting
    - Research Site
  - Gotse Delchev, Bulgaria, 2900
    - Recruiting
    - Research Site
  - Kozloduy, Bulgaria, 3320
    - Recruiting
    - Research Site
  - Lom, Bulgaria, 3600
    - Recruiting
    - Research Site
  - Pernik, Bulgaria, 2300
    - Recruiting
    - Research Site
  - Plovdiv, Bulgaria, 4004
    - Recruiting
    - Research Site
  - Rousse, Bulgaria, 7013
    - Recruiting
    - Research Site
  - Sandanski, Bulgaria, 2800
    - Recruiting
    - Research Site
  - Sevlievo, Bulgaria, 5403
    - Recruiting
    - Research Site
  - Sliven, Bulgaria, 8800
    - Recruiting
    - Research Site
  - Sofia, Bulgaria, 1431
    - Recruiting
    - Research Site
  - Sofia, Bulgaria, 1680
    - Recruiting
    - Research Site
  - Sofia, Bulgaria
    - Recruiting
    - Research Site
  - Varna, Bulgaria, 9000
    - Recruiting
    - Research Site
  - Varna, Bulgaria, 9010
    - Recruiting
    - Research Site
  - Veliko Tarnovo, Bulgaria, 5000
    - Recruiting
    - Research Site
  - Yambol, Bulgaria, 8600
    - Withdrawn
    - Research Site
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 2P4
    - Recruiting
    - Research Site
- British Columbia
  - Surrey, British Columbia, Canada, V3T 0H1
    - Recruiting
    - Research Site
  - Vancouver, British Columbia, Canada, V6Z 1Y6
    - Withdrawn
    - Research Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R2V 3M3
    - Recruiting
    - Research Site
- New Brunswick
  - Saint John, New Brunswick, Canada, E2L 4L2
    - Recruiting
    - Research Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V7
    - Recruiting
    - Research Site
- Ontario
  - Etobicoke, Ontario, Canada, M9W 6V1
    - Recruiting
    - Research Site
  - London, Ontario, Canada, N6A 5A5
    - Recruiting
    - Research Site
  - Oshawa, Ontario, Canada, L1G 2B9
    - Recruiting
    - Research Site
  - Sarnia, Ontario, Canada, N7T 4X3
    - Recruiting
    - Research Site
  - Toronto, Ontario, Canada, M3M 0B2
    - Recruiting
    - Research Site
  - Toronto, Ontario, Canada, M9V 4B4
    - Recruiting
    - Research Site
  - Toronto, Ontario, Canada, M5G 2N2
    - Recruiting
    - Research Site
  - Toronto, Ontario, Canada, M4G 3E8
    - Recruiting
    - Research Site
  - Waterloo, Ontario, Canada, N2T 0C1
    - Recruiting
    - Research Site
- Quebec
  - Laval, Quebec, Canada, H7T 2P5
    - Recruiting
    - Research Site
  - Montreal, Quebec, Canada, H1T 2M4
    - Recruiting
    - Research Site
  - Montreal, Quebec, Canada, H4J 1C5
    - Recruiting
    - Research Site
  - Montreal, Quebec, Canada, H2X 0A9
    - Recruiting
    - Research Site
  - Montreal, Quebec, Canada, H4J 1E3
    - Recruiting
    - Research Site
  - Québec, Quebec, Canada, G1R 2J6
    - Recruiting
    - Research Site
Chile
- - Araucania, Chile, 4781151
    - Recruiting
    - Research Site
  - Santiago, Chile, 7500922
    - Recruiting
    - Research Site
  - Santiago, Chile, 8331143
    - Recruiting
    - Research Site
  - Valdivia, Chile, 5090000
    - Recruiting
    - Research Site
  - Victoria, Chile, 4720000
    - Recruiting
    - Research Site
  - Viña del Mar, Chile, 2540488
    - Withdrawn
    - Research Site
China
- - Baotou, China, 014010
    - Recruiting
    - Research Site
  - Beijing, China, 100034
    - Recruiting
    - Research Site
  - Beijing, China, 100068
    - Recruiting
    - Research Site
  - Beijing, China, CN-100083
    - Recruiting
    - Research Site
  - Changchun, China, 130041
    - Not yet recruiting
    - Research Site
  - Changsha, China, 410008
    - Recruiting
    - Research Site
  - Changsha, China, 410015
    - Recruiting
    - Research Site
  - Changzhou, China, 272100
    - Recruiting
    - Research Site
  - Chengdu, China, 610000
    - Recruiting
    - Research Site
  - Chengdu, China, 610072
    - Recruiting
    - Research Site
  - Chongqing, China, 400010
    - Recruiting
    - Research Site
  - Dongwan, China, 523058
    - Recruiting
    - Research Site
  - Fuyang, China, 236012
    - Not yet recruiting
    - Research Site
  - Guangzhou, China, 510280
    - Recruiting
    - Research Site
  - Guangzhou, China, 510800
    - Recruiting
    - Research Site
  - Guangzhou, China, 511486
    - Not yet recruiting
    - Research Site
  - Guangzhou, China, 510665
    - Not yet recruiting
    - Research Site
  - Haikou, China, 570311
    - Recruiting
    - Research Site
  - Hefei, China, 230601
    - Recruiting
    - Research Site
  - Hefei, China, 230061
    - Recruiting
    - Research Site
  - Hengyang, China, 421001
    - Recruiting
    - Research Site
  - Heze, China, 274099
    - Not yet recruiting
    - Research Site
  - Huaian, China, 223399
    - Recruiting
    - Research Site
  - Jiaxing, China, 314001
    - Recruiting
    - Research Site
  - Jilin, China, 132011
    - Recruiting
    - Research Site
  - Jinan, China, 250021
    - Recruiting
    - Research Site
  - Jining, China, 272006
    - Recruiting
    - Research Site
  - Lanzhou, China, 730000
    - Recruiting
    - Research Site
  - Linhai, China, 317000
    - Recruiting
    - Research Site
  - Linyi, China, 276003
    - Not yet recruiting
    - Research Site
  - Luoyang, China, 471003
    - Recruiting
    - Research Site
  - Nanchang, China, 330006
    - Recruiting
    - Research Site
  - Nanning, China
    - Recruiting
    - Research Site
  - Ningbo, China, 315010
    - Recruiting
    - Research Site
  - Ningbo, China, 315099
    - Recruiting
    - Research Site
  - Ningbo, China, 315800
    - Recruiting
    - Research Site
  - Panjin, China, 124009
    - Recruiting
    - Research Site
  - Pingxiang, China, 337055
    - Recruiting
    - Research Site
  - Shanghai, China, 201199
    - Recruiting
    - Research Site
  - Shanghai, China, 200080
    - Not yet recruiting
    - Research Site
  - Shanghai, China, 200061
    - Recruiting
    - Research Site
  - Shantou, China, 515041
    - Recruiting
    - Research Site
  - Shenyang, China, 110004
    - Recruiting
    - Research Site
  - Shenzhen, China, 518036
    - Recruiting
    - Research Site
  - Shenzhen, China, 518053
    - Recruiting
    - Research Site
  - Suzhou, China, 215004
    - Recruiting
    - Research Site
  - Taian, China, 271099
    - Not yet recruiting
    - Research Site
  - Tianjin, China, CN-300052
    - Recruiting
    - Research Site
  - Wanzhou, China, 404000
    - Recruiting
    - Research Site
  - Wuhan, China, 430010
    - Recruiting
    - Research Site
  - Wuhan, China, 430000
    - Recruiting
    - Research Site
  - Wuxi, China, 214023
    - Recruiting
    - Research Site
  - Xi'an, China, 710061
    - Recruiting
    - Research Site
  - Xianyang, China, 750004
    - Recruiting
    - Research Site
  - Yantai, China, 264000
    - Recruiting
    - Research Site
  - Yinchuan, China, 750004
    - Recruiting
    - Research Site
  - Zhengzhou, China, 450000
    - Recruiting
    - Research Site
  - Zhongshan, China, 528401
    - Recruiting
    - Research Site
  - Zhuzhou, China, 412007
    - Recruiting
    - Research Site
  - Zigong, China, 643000
    - Recruiting
    - Research Site
Colombia
- - Barranquilla, Colombia, 80007
    - Recruiting
    - Research Site
  - Barranquilla, Colombia, 080020
    - Recruiting
    - Research Site
  - Bogotá, Colombia, 111411
    - Recruiting
    - Research Site
  - Cali, Colombia, 760042
    - Recruiting
    - Research Site
  - Medellín, Colombia, 050034
    - Recruiting
    - Research Site
  - Medellín, Colombia, 050030
    - Recruiting
    - Research Site
  - Montería, Colombia, 230002
    - Not yet recruiting
    - Research Site
  - Pasto, Colombia, 520002
    - Recruiting
    - Research Site
Czechia
- - Brandýs nad Labem, Czechia, 250 01
    - Suspended
    - Research Site
  - Brandýs nad Labem, Czechia, 250 01
    - Recruiting
    - Research Site
  - Frýdek-Místek, Czechia, 738 01
    - Suspended
    - Research Site
  - Jilemnice, Czechia, 514 01
    - Recruiting
    - Research Site
  - Krnov, Czechia, 794 01
    - Completed
    - Research Site
  - Mladá Boleslav, Czechia, 293 01
    - Recruiting
    - Research Site
  - Náchod, Czechia, 547 01
    - Recruiting
    - Research Site
  - Olomouc, Czechia, 772 00
    - Suspended
    - Research Site
  - Pilsen, Czechia, 323 00
    - Recruiting
    - Research Site
  - Prague, Czechia, 104 00
    - Recruiting
    - Research Site
  - Prague, Czechia, 140 00
    - Recruiting
    - Research Site
  - Prague, Czechia, 160 00
    - Suspended
    - Research Site
  - Slaný, Czechia, 274 01
    - Recruiting
    - Research Site
Denmark
- - Aalborg, Denmark, 9000
    - Recruiting
    - Research Site
  - Aarhus, Denmark, 8200
    - Recruiting
    - Research Site
  - Copenhagen E, Denmark, 2100
    - Recruiting
    - Research Site
  - Herlev, Denmark, 2730
    - Recruiting
    - Research Site
  - Herning, Denmark, 7400
    - Recruiting
    - Research Site
  - Holbæk, Denmark, 4300
    - Recruiting
    - Research Site
  - Kolding, Denmark, 6000
    - Recruiting
    - Research Site
Egypt
- - Cairo, Egypt, 11566
    - Withdrawn
    - Research Site
  - Cairo, Egypt, 11734
    - Withdrawn
    - Research Site
  - Cairo, Egypt, 4540046
    - Withdrawn
    - Research Site
  - Dakahlia, Egypt, 35516
    - Withdrawn
    - Research Site
  - Dakahlia, Egypt, 7650030
    - Withdrawn
    - Research Site
France
- - Amiens, France, 80054
    - Recruiting
    - Research Site
  - Bordeaux, France, 33076
    - Recruiting
    - Research Site
  - Boulogne-Billancourt, France, 92104
    - Recruiting
    - Research Site
  - Brest, France, 29200
    - Recruiting
    - Research Site
  - Clermont-Ferrand, France, 63003
    - Recruiting
    - Research Site
  - Créteil, France, 94000
    - Recruiting
    - Research Site
  - La Roche-sur-Yon, France, 85925
    - Recruiting
    - Research Site
  - Le Mans, France, 72037
    - Recruiting
    - Research Site
  - Limoges, France, 87042
    - Recruiting
    - Research Site
  - Lyon, France, 69437
    - Recruiting
    - Research Site
  - Marseille, France, 13005
    - Recruiting
    - Research Site
  - Nantes, France, 44093
    - Recruiting
    - Research Site
  - Nice, France, 06000
    - Recruiting
    - Research Site
  - Nîmes, France, 30000
    - Recruiting
    - Research Site
  - Paris, France, 75015
    - Recruiting
    - Research Site
  - Paris, France, 75018
    - Recruiting
    - Research Site
  - Pierre-Bénite, France, 69495
    - Recruiting
    - Research Site
  - Poitiers, France, 86021
    - Recruiting
    - Research Site
  - Quimper, France, 29000
    - Recruiting
    - Research Site
  - Reims, France, 51100
    - Recruiting
    - Research Site
  - Rouen, France, 76031
    - Recruiting
    - Research Site
  - Saint-Priest-en-Jarez, France, 42270
    - Recruiting
    - Research Site
  - Strasbourg, France, 67098
    - Recruiting
    - Research Site
  - Tours, France, 37044
    - Recruiting
    - Research Site
  - Vandœuvre-lès-Nancy, France, 54511
    - Recruiting
    - Research Site
Germany
- - Bad Homburg, Germany, 61348
    - Recruiting
    - Research Site
  - Bamberg, Germany, 96049
    - Recruiting
    - Research Site
  - Berlin, Germany, 10117
    - Recruiting
    - Research Site
  - Berlin, Germany, 13509
    - Recruiting
    - Research Site
  - Berlin, Germany, 10629
    - Recruiting
    - Research Site
  - Bochum, Germany, 44787
    - Recruiting
    - Research Site
  - Brandenburg an der Havel, Germany, 14770
    - Recruiting
    - Research Site
  - Brandenburg an der Havel, Germany, 14776
    - Recruiting
    - Research Site
  - Dresden, Germany, 01279
    - Recruiting
    - Research Site
  - Essen, Germany, 45122
    - Recruiting
    - Research Site
  - Friedrichsthal, Germany, 66299
    - Withdrawn
    - Research Site
  - Görlitz, Germany, 02828
    - Recruiting
    - Research Site
  - Göttingen, Germany, 37075
    - Recruiting
    - Research Site
  - Hamburg, Germany, 21109
    - Withdrawn
    - Research Site
  - Hanover, Germany, 30625
    - Recruiting
    - Research Site
  - Hanover, Germany, 30449
    - Recruiting
    - Research Site
  - Hanover, Germany, 30459
    - Recruiting
    - Research Site
  - Heidelberg, Germany, 69120
    - Recruiting
    - Research Site
  - Heidelberg, Germany, 69115
    - Withdrawn
    - Research Site
  - Herne, Germany, 44625
    - Recruiting
    - Research Site
  - Karlsburg, Germany, 17495
    - Recruiting
    - Research Site
  - Karlsruhe, Germany, 76137
    - Recruiting
    - Research Site
  - Karlsruhe, Germany, 76133
    - Not yet recruiting
    - Research Site
  - Landshut, Germany, 84034
    - Recruiting
    - Research Site
  - Mainz, Germany, 55131
    - Recruiting
    - Research Site
  - Obertshausen, Germany, 63179
    - Recruiting
    - Research Site
  - Offenbach, Germany, 63065
    - Recruiting
    - Research Site
  - Potsdam, Germany, 14473
    - Recruiting
    - Research Site
  - Reinfeld (Holstein), Germany, 23858
    - Active, not recruiting
    - Research Site
  - Rostock, Germany, 18057
    - Recruiting
    - Research Site
  - Rotenburg (Wümme), Germany, 27356
    - Recruiting
    - Research Site
  - Stuttgart, Germany, 70376
    - Withdrawn
    - Research Site
  - Ulm, Germany, 89081
    - Recruiting
    - Research Site
  - Wermsdorf, Germany, 04779
    - Recruiting
    - Research Site
  - Zwenkau, Germany, 04442
    - Recruiting
    - Research Site
Greece
- - Alexandroupoli, Greece, 68100
    - Recruiting
    - Research Site
  - Athens, Greece, 11527
    - Recruiting
    - Research Site
  - Heraklion, Greece, 71500
    - Recruiting
    - Research Site
  - Ioannina, Greece, 45500
    - Recruiting
    - Research Site
  - Pátrai, Greece, 26504
    - Recruiting
    - Research Site
  - Thessaloniki, Greece, 57010
    - Recruiting
    - Research Site
  - Thessaloniki, Greece, 54642
    - Recruiting
    - Research Site
  - Thessaloniki, Greece, 54636
    - Recruiting
    - Research Site
Hungary
- - Budapest, Hungary, 1036
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1085
    - Recruiting
    - Research Site
  - Budapest, Hungary, 1138
    - Not yet recruiting
    - Research Site
  - Budapest, Hungary, 1132
    - Recruiting
    - Research Site
  - Dunaújváros, Hungary, 2400
    - Recruiting
    - Research Site
  - Encs, Hungary, 3860
    - Withdrawn
    - Research Site
  - Győr, Hungary, 9024
    - Recruiting
    - Research Site
  - Kaposvár, Hungary, 7400
    - Recruiting
    - Research Site
  - Nyíregyháza, Hungary, 4400
    - Recruiting
    - Research Site
  - Nyíregyháza, Hungary, 4405
    - Withdrawn
    - Research Site
  - Szeged, Hungary, 6725
    - Recruiting
    - Research Site
  - Szeged, Hungary, 6724
    - Withdrawn
    - Research Site
  - Szolnok, Hungary, 5004
    - Recruiting
    - Research Site
  - Székesfehérvár, Hungary, 8000
    - Recruiting
    - Research Site
  - Zalaegerszeg, Hungary, 8900
    - Recruiting
    - Research Site
India
- - Bangalore, India, 560060
    - Suspended
    - Research Site
  - Belagavi, India, 590010
    - Recruiting
    - Research Site
  - Hyderabad, India, 500082
    - Recruiting
    - Research Site
  - Hyderabad, India, 500 034
    - Withdrawn
    - Research Site
  - Kolkata, India, 700020
    - Recruiting
    - Research Site
  - Kolkata, India, 700014
    - Recruiting
    - Research Site
  - Madurai, India, 625107
    - Recruiting
    - Research Site
  - Mumbai, India, 400026
    - Recruiting
    - Research Site
  - New Delhi, India, 110029
    - Recruiting
    - Research Site
  - New Delhi, India, 110017
    - Recruiting
    - Research Site
  - New Delhi, India, 110001
    - Recruiting
    - Research Site
  - New Delhi, India, 110029
    - Suspended
    - Research Site
  - Pune, India, 411013
    - Recruiting
    - Research Site
  - Vijayawada, India, 522002
    - Recruiting
    - Research Site
  - Vijayawada, India, 520 008
    - Recruiting
    - Research Site
Israel
- - Afula, Israel, 18101
    - Recruiting
    - Research Site
  - Ashdod, Israel, 7747629
    - Recruiting
    - Research Site
  - Be’er Ya‘aqov, Israel, 70300
    - Recruiting
    - Research Site
  - Haifa, Israel, 3109601
    - Recruiting
    - Research Site
  - Haifa, Israel, 34362
    - Recruiting
    - Research Site
  - Jerusalem, Israel, 91120
    - Withdrawn
    - Research Site
  - Kfar Saba, Israel, 44281
    - Recruiting
    - Research Site
  - Nahariya, Israel, 22100
    - Recruiting
    - Research Site
  - Petah Tikva, Israel, 49372
    - Recruiting
    - Research Site
  - Rehovot, Israel, 76100
    - Recruiting
    - Research Site
  - Tel Aviv, Israel, 6423906
    - Recruiting
    - Research Site
  - Tiberias, Israel, 15208
    - Recruiting
    - Research Site
Italy
- - Bassano del Grappa, Italy, 36031
    - Recruiting
    - Research Site
  - Bologna, Italy, 40138
    - Recruiting
    - Research Site
  - Desio, Italy, 20832
    - Recruiting
    - Research Site
  - Foggia, Italy, 71100
    - Recruiting
    - Research Site
  - Genoa, Italy, 16132
    - Recruiting
    - Research Site
  - Modena, Italy, 41124
    - Recruiting
    - Research Site
  - Naples, Italy, 80138
    - Recruiting
    - Research Site
  - Novara, Italy, 28100
    - Recruiting
    - Research Site
  - Padova, Italy, 35128
    - Recruiting
    - Research Site
  - Pavia, Italy, 27100
    - Recruiting
    - Research Site
  - Pisa, Italy, 56124
    - Recruiting
    - Research Site
  - Pordenone, Italy, 33170
    - Recruiting
    - Research Site
  - Roma, Italy, 00168
    - Recruiting
    - Research Site
  - Rozzano, Italy, 20089
    - Recruiting
    - Research Site
  - Torino, Italy, 10126
    - Recruiting
    - Research Site
  - Tradate, Italy, 21049
    - Recruiting
    - Research Site
Japan
- - Aira, Japan, 899-5421
    - Recruiting
    - Research Site
  - Amagasaki-shi, Japan, 660-8550
    - Recruiting
    - Research Site
  - Beppu-shi, Japan, 874-0011
    - Recruiting
    - Research Site
  - Chigasaki-shi, Japan, 253-0044
    - Recruiting
    - Research Site
  - Fujinomiya-shi, Japan, 418-0076
    - Withdrawn
    - Research Site
  - Hakodate-shi, Japan, 041-8680
    - Recruiting
    - Research Site
  - Hamamatsu, Japan, 432-8580
    - Recruiting
    - Research Site
  - Higashihiroshima-shi, Japan, 739-0041
    - Recruiting
    - Research Site
  - Iizuka-shi, Japan, 820-8505
    - Recruiting
    - Research Site
  - Inashiki-gun, Japan, 300-0395
    - Recruiting
    - Research Site
  - Itabashi-ku, Japan, 173-0015
    - Recruiting
    - Research Site
  - Iwata-shi, Japan, 438-8550
    - Recruiting
    - Research Site
  - Kagoshima, Japan, 890-0073
    - Recruiting
    - Research Site
  - Kamakura-shi, Japan, 247-0056
    - Recruiting
    - Research Site
  - Kanazawa, Japan, 920-8530
    - Recruiting
    - Research Site
  - Kashiwara-shi, Japan, 582-0005
    - Recruiting
    - Research Site
  - Kasugai-shi, Japan, 486-8510
    - Recruiting
    - Research Site
  - Kita-ku, Japan, 144-0001
    - Recruiting
    - Research Site
  - Kitakyushu, Japan, 802-8555
    - Recruiting
    - Research Site
  - Kitakyushu-shi, Japan, 807-0857
    - Recruiting
    - Research Site
  - Kobe, Japan, 650-0017
    - Recruiting
    - Research Site
  - Kobe, Japan, 650-0047
    - Withdrawn
    - Research Site
  - Kumagaya-shi, Japan, 360-0197
    - Recruiting
    - Research Site
  - Kurashiki Shi, Japan, 701 0192
    - Recruiting
    - Research Site
  - Kuse-gun, Japan, 613-0034
    - Recruiting
    - Research Site
  - Kuwana-shi, Japan, 511-0061
    - Recruiting
    - Research Site
  - Kyoto, Japan, 612-8555
    - Recruiting
    - Research Site
  - Kyoto, Japan, 604-8845
    - Recruiting
    - Research Site
  - Matsusaka-shi, Japan, 515-8557
    - Recruiting
    - Research Site
  - Matsuyama, Japan, 790-0024
    - Recruiting
    - Research Site
  - Matsuyama, Japan, 790-8524
    - Recruiting
    - Research Site
  - Meguro-ku, Japan, 153-0051
    - Recruiting
    - Research Site
  - Minatoku, Japan, 108-0073
    - Recruiting
    - Research Site
  - Minatoku, Japan, 105-8471
    - Recruiting
    - Research Site
  - Minokamo Shi, Japan, 505-8510
    - Recruiting
    - Research Site
  - Miyakonojo-shi, Japan, 885-0035
    - Recruiting
    - Research Site
  - Morioka, Japan, 020-0066
    - Recruiting
    - Research Site
  - Nagaoka-shi, Japan, 940-8621
    - Recruiting
    - Research Site
  - Naka, Japan, 311-0113
    - Recruiting
    - Research Site
  - Narita-shi, Japan, 286-8520
    - Recruiting
    - Research Site
  - Obihiro-shi, Japan, 080-0848
    - Recruiting
    - Research Site
  - Osaka, Japan, 553-0003
    - Recruiting
    - Research Site
  - Osaka, Japan, 543-0035
    - Recruiting
    - Research Site
  - Osaka, Japan, 534-0021
    - Withdrawn
    - Research Site
  - Osaka, Japan, 558-8558
    - Recruiting
    - Research Site
  - Osaka, Japan, 559-0012
    - Recruiting
    - Research Site
  - Saga, Japan, 849-8501
    - Recruiting
    - Research Site
  - Sapporo, Japan, 003-0026
    - Recruiting
    - Research Site
  - Sapporo, Japan, 060-0061
    - Recruiting
    - Research Site
  - Sapporo, Japan, 062-0921
    - Recruiting
    - Research Site
  - Sendai, Japan, 980-8574
    - Recruiting
    - Research Site
  - Sendai, Japan, 981-3281
    - Recruiting
    - Research Site
  - Shibuya-ku, Japan, 151-8528
    - Recruiting
    - Research Site
  - Tanabe-shi, Japan, 646-8558
    - Recruiting
    - Research Site
  - Toyoake-shi, Japan, 470-1192
    - Recruiting
    - Research Site
  - Toyohashi, Japan, 441-8570
    - Recruiting
    - Research Site
  - Tsu, Japan, 514-8507
    - Recruiting
    - Research Site
  - Yaizu-shi, Japan, 425-8505
    - Recruiting
    - Research Site
  - Yokohama, Japan, 236-0004
    - Recruiting
    - Research Site
  - Yoshida-gun, Japan, 910-1193
    - Recruiting
    - Research Site
  - Ōita, Japan, 870-0039
    - Recruiting
    - Research Site
  - Ōme, Japan, 198-0042
    - Recruiting
    - Research Site
  - Ōmihachiman, Japan, 523-0082
    - Recruiting
    - Research Site
Malaysia
- - Ampang, Malaysia, 68000
    - Recruiting
    - Research Site
  - Cheras, Malaysia, 56000
    - Recruiting
    - Research Site
  - Ipoh, Malaysia, 30990
    - Recruiting
    - Research Site
  - Kajang, Malaysia, 43000
    - Recruiting
    - Research Site
  - Kota Bharu, Malaysia, 15586
    - Recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 59100
    - Recruiting
    - Research Site
  - Seremban, Malaysia, 70300
    - Recruiting
    - Research Site
  - Seri Manjung, Malaysia, 32040
    - Recruiting
    - Research Site
Mexico
- - Chihuahua City, Mexico, 31000
    - Recruiting
    - Research Site
  - Cuauhtémoc, Mexico, 06700
    - Not yet recruiting
    - Research Site
  - Cuauhtémoc, Mexico, 06700
    - Recruiting
    - Research Site
  - D.F, Mexico, 14000
    - Recruiting
    - Research Site
  - Durango, Mexico, 34000
    - Recruiting
    - Research Site
  - Guadalajara, Mexico, 44670
    - Recruiting
    - Research Site
  - Guadalajara, Mexico, 44690
    - Recruiting
    - Research Site
  - Mazatlán, Mexico, 82000
    - Recruiting
    - Research Site
  - Mazatlán, Mexico, 82110
    - Recruiting
    - Research Site
  - Mérida, Mexico, 97130
    - Recruiting
    - Research Site
  - San Luis Potosí City, Mexico, 78250
    - Recruiting
    - Research Site
  - Veracruz, Mexico, 91855
    - Recruiting
    - Research Site
  - Zapopan, Mexico, 45138
    - Recruiting
    - Research Site
Netherlands
- - Amersfoort, Netherlands, 3813 TZ
    - Recruiting
    - Research Site
  - Amsterdam, Netherlands, 1105 AZ
    - Recruiting
    - Research Site
  - Dordrecht, Netherlands, 3318 AT
    - Recruiting
    - Research Site
  - Groningen, Netherlands, 9713 GZ
    - Recruiting
    - Research Site
  - Hilversum, Netherlands, 1212 VG
    - Recruiting
    - Research Site
  - Leiden, Netherlands, 2333 ZA
    - Recruiting
    - Research Site
  - Maastricht, Netherlands, 6229 HX
    - Recruiting
    - Research Site
  - Nieuwegein, Netherlands, 3435 CM
    - Recruiting
    - Research Site
  - Zwolle, Netherlands, 8025 AB
    - Recruiting
    - Research Site
Peru
- - Arequipa, Peru, AREQUIPA01
    - Suspended
    - Research Site
  - Bellavista, Peru, CALLAO 2
    - Not yet recruiting
    - Research Site
  - Chorrillos, Peru, Lima 9
    - Recruiting
    - Research Site
  - Cusco, Peru, CUSCO 01
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15036
    - Recruiting
    - Research Site
  - Lima, Peru, 15046
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15088
    - Recruiting
    - Research Site
  - Lima, Peru, 14
    - Recruiting
    - Research Site
  - Lima, Peru, LIMA 01
    - Recruiting
    - Research Site
  - Lima, Peru, 15046
    - Suspended
    - Research Site
  - Lima, Peru, 15074
    - Withdrawn
    - Research Site
  - Piura, Peru, 20001
    - Recruiting
    - Research Site
Philippines
- - Cebu City, Philippines, 6000
    - Recruiting
    - Research Site
  - Davao City, Philippines, 8000
    - Recruiting
    - Research Site
  - Davao City, Philippines, PH-8000
    - Recruiting
    - Research Site
  - Iloilo City, Philippines, 5000
    - Recruiting
    - Research Site
  - Laguna, Philippines, 4024
    - Recruiting
    - Research Site
  - Manadaluyong City, Philippines, 1552
    - Not yet recruiting
    - Research Site
  - Manila, Philippines, 1000
    - Not yet recruiting
    - Research Site
  - Quezon City, Philippines, 1101
    - Recruiting
    - Research Site
  - Quezon City, Philippines
    - Withdrawn
    - Research Site
  - San Fernando City, Philippines, 2000
    - Withdrawn
    - Research Site
Poland
- - Bialystok, Poland, 15-540
    - Recruiting
    - Research Site
  - Gdynia, Poland, 81-519
    - Recruiting
    - Research Site
  - Gdynia, Poland, 81-157
    - Recruiting
    - Research Site
  - Gmina Świecie, Poland, 86-100
    - Recruiting
    - Research Site
  - Jasło, Poland, 38-200
    - Suspended
    - Research Site
  - Katowice, Poland, 40-648
    - Recruiting
    - Research Site
  - Katowice, Poland, 40-600
    - Recruiting
    - Research Site
  - Katowice, Poland, 40-772
    - Recruiting
    - Research Site
  - Krakow, Poland, 31-501
    - Recruiting
    - Research Site
  - Krakow, Poland, 31-261
    - Recruiting
    - Research Site
  - Krakow, Poland, 31-513
    - Recruiting
    - Research Site
  - Krakow, Poland, 30-688
    - Recruiting
    - Research Site
  - Krakow, Poland, 30-688
    - Suspended
    - Research Site
  - Lodz, Poland, 92-213
    - Recruiting
    - Research Site
  - Lodz, Poland, 91-363
    - Recruiting
    - Research Site
  - Lublin, Poland, 20-718
    - Recruiting
    - Research Site
  - Piaseczno, Poland, 05-500
    - Withdrawn
    - Research Site
  - Poznan, Poland, 60-309
    - Recruiting
    - Research Site
  - Poznan, Poland, 61-848
    - Recruiting
    - Research Site
  - Poznan, Poland, 60-354
    - Not yet recruiting
    - Research Site
  - Pruszków, Poland, 05-800
    - Recruiting
    - Research Site
  - Radom, Poland, 26-600
    - Recruiting
    - Research Site
  - Rzeszów, Poland, 35-055
    - Recruiting
    - Research Site
  - Szczecin, Poland, 71-434
    - Recruiting
    - Research Site
  - Szczecin, Poland, 70-111
    - Recruiting
    - Research Site
  - Szczecin, Poland, 71-526
    - Recruiting
    - Research Site
  - Tczew, Poland, 83-110
    - Recruiting
    - Research Site
  - Warsaw, Poland, 02-507
    - Recruiting
    - Research Site
  - Warsaw, Poland, 00-124
    - Recruiting
    - Research Site
  - Warsaw, Poland, 02-097
    - Recruiting
    - Research Site
  - Warsaw, Poland, 03-291
    - Recruiting
    - Research Site
  - Warsaw, Poland, 00-719
    - Not yet recruiting
    - Research Site
  - Warsaw, Poland, 02-595
    - Recruiting
    - Research Site
  - Warsaw, Poland, 02-798
    - Recruiting
    - Research Site
  - Wroclaw, Poland, 53-673
    - Recruiting
    - Research Site
  - Wroclaw, Poland, 50-304
    - Recruiting
    - Research Site
  - Żywiec, Poland, 34-300
    - Recruiting
    - Research Site
Romania
- - Brasov, Romania, 500073
    - Withdrawn
    - Research Site
  - Bucharest, Romania, 042122
    - Recruiting
    - Research Site
  - Bucharest, Romania, 22328
    - Recruiting
    - Research Site
  - Bucharest, Romania, 060044
    - Recruiting
    - Research Site
  - Bucharest, Romania, 22325
    - Withdrawn
    - Research Site
  - Cluj-Napoca, Romania, 400349
    - Recruiting
    - Research Site
  - Craiova, Romania, 200642
    - Recruiting
    - Research Site
  - Craiova, Romania, 200349
    - Recruiting
    - Research Site
  - Oradea, Romania, 410469
    - Recruiting
    - Research Site
  - Suceava, Romania, 720237
    - Recruiting
    - Research Site
  - Timișoara, Romania, 300723
    - Recruiting
    - Research Site
Saudi Arabia
- - Al-Ahsa, Saudi Arabia, 36428
    - Recruiting
    - Research Site
  - Dammam, Saudi Arabia, 31444
    - Recruiting
    - Research Site
  - Riyadh, Saudi Arabia, 11426
    - Recruiting
    - Research Site
  - Riyadh, Saudi Arabia, 12231
    - Not yet recruiting
    - Research Site
  - Riyadh, Saudi Arabia, 11462
    - Recruiting
    - Research Site
  - Riyadh, Saudi Arabia, 11211
    - Withdrawn
    - Research Site
  - Riyadh/MENA, Saudi Arabia, 11426
    - Recruiting
    - Research Site
Serbia
- - Belgrade, Serbia, 11000
    - Not yet recruiting
    - Research Site
  - Belgrade, Serbia, 11000
    - Withdrawn
    - Research Site
  - Belgrade, Serbia, 11070
    - Not yet recruiting
    - Research Site
  - Belgrade, Serbia, 11000
    - Recruiting
    - Research Site
  - Belgrade, Serbia, 11120
    - Withdrawn
    - Research Site
  - Kamenitz, Serbia, 21204
    - Recruiting
    - Research Site
  - Kragujevac, Serbia, 34000
    - Recruiting
    - Research Site
  - Kragujevac, Serbia, 34000
    - Withdrawn
    - Research Site
  - Niš, Serbia, 18000
    - Recruiting
    - Research Site
  - Novi Sad, Serbia, 21000
    - Recruiting
    - Research Site
  - Novi Sad, Serbia, 21000
    - Withdrawn
    - Research Site
Singapore
- - Singapore, Singapore, 308433
    - Recruiting
    - Research Site
  - Singapore, Singapore, 119074
    - Recruiting
    - Research Site
  - Singapore, Singapore, 169608
    - Recruiting
    - Research Site
  - Singapore, Singapore, 529889
    - Recruiting
    - Research Site
Slovakia
- - Košice, Slovakia, 040 01
    - Recruiting
    - Research Site
  - Kráľovský Chlmec, Slovakia, 077 01
    - Withdrawn
    - Research Site
  - Myjava, Slovakia, 90701
    - Recruiting
    - Research Site
  - Nitra, Slovakia, 949 11
    - Recruiting
    - Research Site
  - Prešov, Slovakia, 080 01
    - Withdrawn
    - Research Site
  - Prešov, Slovakia, 080 01
    - Recruiting
    - Research Site
  - Púchov, Slovakia, 020 01
    - Recruiting
    - Research Site
  - Trenčín, Slovakia, 91171
    - Recruiting
    - Research Site
  - Trnava, Slovakia, 917 02
    - Recruiting
    - Research Site
  - Žilina, Slovakia, 010 01
    - Recruiting
    - Research Site
South Africa
- - Bellville, South Africa, 7530
    - Recruiting
    - Research Site
  - Benoni, South Africa, 1501
    - Recruiting
    - Research Site
  - Bloemfontein, South Africa, 9301
    - Recruiting
    - Research Site
  - Bloemfontein, South Africa, 9301
    - Withdrawn
    - Research Site
  - Cape Town, South Africa, 7570
    - Recruiting
    - Research Site
  - Cape Town, South Africa, 7925
    - Recruiting
    - Research Site
  - Durban, South Africa, 4091
    - Recruiting
    - Research Site
  - Durban, South Africa, 4450
    - Withdrawn
    - Research Site
  - Durban, South Africa, 4092
    - Withdrawn
    - Research Site
  - Johannesburg, South Africa, 1827
    - Recruiting
    - Research Site
  - KwaDukuza, South Africa, 4449
    - Recruiting
    - Research Site
  - Lenasia, South Africa, 1827
    - Recruiting
    - Research Site
  - Midrand, South Africa, 1685
    - Recruiting
    - Research Site
  - Newton, South Africa, 2113
    - Recruiting
    - Research Site
  - Parow, South Africa, 7505
    - Withdrawn
    - Research Site
South Korea
- - Ansan-si, South Korea, 15355
    - Recruiting
    - Research Site
  - Anyang-si, South Korea, 14068
    - Recruiting
    - Research Site
  - Busan, South Korea, 49241
    - Recruiting
    - Research Site
  - Cheonan-si, South Korea, 31151
    - Recruiting
    - Research Site
  - Goyang-si, South Korea, 10380
    - Recruiting
    - Research Site
  - Gwangju, South Korea, 61469
    - Recruiting
    - Research Site
  - Seongnam-si, South Korea, 13620
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03722
    - Recruiting
    - Research Site
  - Seoul, South Korea, 07061
    - Recruiting
    - Research Site
  - Seoul, South Korea, 04401
    - Recruiting
    - Research Site
  - Wŏnju, South Korea, 26426
    - Recruiting
    - Research Site
  - Yangsan, South Korea, 50612
    - Recruiting
    - Research Site
Spain
- - A Coruña, Spain, 15006
    - Recruiting
    - Research Site
  - Almería, Spain, 4009
    - Recruiting
    - Research Site
  - Badalona, Spain, 08916
    - Recruiting
    - Research Site
  - L'Hospitalet de Llobregat, Spain, 08907
    - Recruiting
    - Research Site
  - Majadahonda, Spain, 28222
    - Recruiting
    - Research Site
  - Málaga, Spain, 29010
    - Recruiting
    - Research Site
  - Palma deMallorca, Spain, 07010
    - Suspended
    - Research Site
  - Pamplona, Spain, 31008
    - Recruiting
    - Research Site
  - Seville, Spain, 41013
    - Recruiting
    - Research Site
  - Seville, Spain, 41071
    - Recruiting
    - Research Site
  - Valencia, Spain, 46010
    - Recruiting
    - Research Site
  - Valencia, Spain, 46017
    - Recruiting
    - Research Site
Sweden
- - Huddinge, Sweden, 141 57
    - Recruiting
    - Research Site
  - Karlstad, Sweden, 651 85
    - Recruiting
    - Research Site
  - Linköping, Sweden, 581 85
    - Recruiting
    - Research Site
  - Stockholm, Sweden, 18288
    - Recruiting
    - Research Site
  - Uppsala, Sweden, 751 85
    - Recruiting
    - Research Site
  - Vaxjo, Sweden, 352 34
    - Recruiting
    - Research Site
Taiwan
- - New Taipei City, Taiwan, 220
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 402
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 433004
    - Recruiting
    - Research Site
  - Taipei, Taiwan, TAIWAN
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 10002
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 110
    - Recruiting
    - Research Site
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Research Site
  - Yung Kang City, Taiwan, 71044
    - Recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10400
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10330
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10700
    - Recruiting
    - Research Site
  - Banphaeo, Thailand, 74120
    - Recruiting
    - Research Site
  - Hat Yai, Thailand, 90110
    - Recruiting
    - Research Site
  - Khon Kaen, Thailand, 40002
    - Recruiting
    - Research Site
  - Mueang, Thailand, 50200
    - Recruiting
    - Research Site
  - Phutthamonthon, Thailand, 73170
    - Recruiting
    - Research Site
  - Ubonratchathani, Thailand, 34000
    - Recruiting
    - Research Site
Turkey (Türkiye)
- - Adana, Turkey (Türkiye), 01060
    - Recruiting
    - Research Site
  - Adapazarı, Turkey (Türkiye), 54100
    - Recruiting
    - Research Site
  - Altındağ, Turkey (Türkiye), 06230
    - Recruiting
    - Research Site
  - Ankara, Turkey (Türkiye), 06530
    - Recruiting
    - Research Site
  - Antalya, Turkey (Türkiye), 07100
    - Recruiting
    - Research Site
  - Haliliye, Turkey (Türkiye), 63040
    - Recruiting
    - Research Site
  - Kahramanmaraş, Turkey (Türkiye), 46040
    - Recruiting
    - Research Site
  - Kayseri, Turkey (Türkiye), 38039
    - Recruiting
    - Research Site
  - Kocaeli, Turkey (Türkiye), 41380
    - Recruiting
    - Research Site
  - Şahinbey, Turkey (Türkiye), 27310
    - Recruiting
    - Research Site
Ukraine
- - Chernivtsі, Ukraine, 58002
    - Recruiting
    - Research Site
  - Ivano-Frankivsk, Ukraine, 76008
    - Recruiting
    - Research Site
  - Kyiv, Ukraine, 04050
    - Recruiting
    - Research Site
  - Kyiv, Ukraine, 01601
    - Recruiting
    - Research Site
  - Kyiv, Ukraine, 03037
    - Recruiting
    - Research Site
  - Kyiv, Ukraine, 03057
    - Recruiting
    - Research Site
  - Kyiv, Ukraine, 03049
    - Recruiting
    - Research Site
  - Ternopil, Ukraine, 46000
    - Recruiting
    - Research Site
  - Ternopil, Ukraine, 46001
    - Recruiting
    - Research Site
  - Uzhhorod, Ukraine, 88018
    - Recruiting
    - Research Site
  - Uzhhorod, Ukraine, 88014
    - Recruiting
    - Research Site
  - Vinnytsia, Ukraine, 21001
    - Recruiting
    - Research Site
  - Vinnytsia, Ukraine, 21029
    - Recruiting
    - Research Site
  - Vinnytsia, Ukraine, 21009
    - Recruiting
    - Research Site
  - Zhytomyr, Ukraine, 10002
    - Terminated
    - Research Site
United Kingdom
- - Bradford, United Kingdom, BND9 6RJ
    - Recruiting
    - Research Site
  - Bristol, United Kingdom, BS105NB
    - Recruiting
    - Research Site
  - Canterbury, United Kingdom, CT1 3NG
    - Recruiting
    - Research Site
  - Cardiff, United Kingdom, CF14 4XW
    - Recruiting
    - Research Site
  - Dundee, United Kingdom, DD1 9SY
    - Recruiting
    - Research Site
  - Glasgow, United Kingdom, G51 4TF
    - Recruiting
    - Research Site
  - Hounslow, United Kingdom, TW3 3LN
    - Recruiting
    - Research Site
  - London, United Kingdom, SE5 9RS
    - Recruiting
    - Research Site
  - London, United Kingdom, E1 1BB
    - Recruiting
    - Research Site
  - Salford, United Kingdom, M6 8HD
    - Recruiting
    - Research Site
  - Southampton, United Kingdom, SO16 6YD
    - Withdrawn
    - Research Site
  - Swansea, United Kingdom, SN6 6NL
    - Recruiting
    - Research Site
United States
- Alabama
  - Fairhope, Alabama, United States, 36532
    - Recruiting
    - Research Site
- Arizona
  - Surprise, Arizona, United States, 85374
    - Recruiting
    - Research Site
  - Tucson, Arizona, United States, 85710
    - Recruiting
    - Research Site
- California
  - Beverly Hills, California, United States, 90211
    - Recruiting
    - Research Site
  - Canoga Park, California, United States, 91303
    - Withdrawn
    - Research Site
  - Concord, California, United States, 94520
    - Recruiting
    - Research Site
  - Fremont, California, United States, 94538
    - Recruiting
    - Research Site
  - Fullerton, California, United States, 92835
    - Recruiting
    - Research Site
  - Inglewood, California, United States, 90301
    - Withdrawn
    - Research Site
  - Los Alamitos, California, United States, 90720
    - Recruiting
    - Research Site
  - Los Angeles, California, United States, 90073
    - Recruiting
    - Research Site
  - San Diego, California, United States, 92120
    - Withdrawn
    - Research Site
  - San Francisco, California, United States, 94110
    - Withdrawn
    - Research Site
  - Stanford, California, United States, 94305
    - Not yet recruiting
    - Research Site
  - Tarzana, California, United States, 91356
    - Recruiting
    - Research Site
- Colorado
  - Arvada, Colorado, United States, 80002
    - Recruiting
    - Research Site
  - Denver, Colorado, United States, 80220
    - Withdrawn
    - Research Site
- Connecticut
  - New Britain, Connecticut, United States, 06051
    - Recruiting
    - Research Site
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20037
    - Recruiting
    - Research Site
- Florida
  - Boca Raton, Florida, United States, 33487
    - Recruiting
    - Research Site
  - Boynton Beach, Florida, United States, 33435
    - Recruiting
    - Research Site
  - Edgewater, Florida, United States, 32132
    - Recruiting
    - Research Site
  - Fort Lauderdale, Florida, United States, 33316
    - Recruiting
    - Research Site
  - Hollywood, Florida, United States, 33021
    - Recruiting
    - Research Site
  - Jacksonville Beach, Florida, United States, 32250
    - Recruiting
    - Research Site
  - Lake City, Florida, United States, 32055
    - Recruiting
    - Research Site
  - Lakeland, Florida, United States, 33805
    - Recruiting
    - Research Site
  - Melbourne, Florida, United States, 32901
    - Recruiting
    - Research Site
  - Miami Lakes, Florida, United States, 33014
    - Suspended
    - Research Site
  - Ocoee, Florida, United States, 34761
    - Recruiting
    - Research Site
  - Port Charlotte, Florida, United States, 33952
    - Recruiting
    - Research Site
  - Port Orange, Florida, United States, 32127
    - Recruiting
    - Research Site
  - Riverview, Florida, United States, 33578
    - Recruiting
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30344
    - Recruiting
    - Research Site
  - Atlanta, Georgia, United States, 30328
    - Recruiting
    - Research Site
  - Augusta, Georgia, United States, 30904
    - Withdrawn
    - Research Site
  - Austell, Georgia, United States, 30106
    - Suspended
    - Research Site
  - Brunswick, Georgia, United States, 31520
    - Recruiting
    - Research Site
  - Conyers, Georgia, United States, 30094
    - Recruiting
    - Research Site
  - Decatur, Georgia, United States, 30030
    - Recruiting
    - Research Site
  - Lawrenceville, Georgia, United States, 30046
    - Recruiting
    - Research Site
  - Riverdale, Georgia, United States, 30274
    - Recruiting
    - Research Site
- Hawaii
  - Honolulu, Hawaii, United States, 96814
    - Suspended
    - Research Site
- Illinois
  - Champaign, Illinois, United States, 61822
    - Recruiting
    - Research Site
  - Maywood, Illinois, United States, 60153
    - Recruiting
    - Research Site
  - Rockford, Illinois, United States, 61107
    - Recruiting
    - Research Site
- Indiana
  - Evansville, Indiana, United States, 47714
    - Withdrawn
    - Research Site
  - Indianapolis, Indiana, United States, 46202
    - Recruiting
    - Research Site
- Iowa
  - Iowa City, Iowa, United States, 52242
    - Recruiting
    - Research Site
  - West Des Moines, Iowa, United States, 50266
    - Recruiting
    - Research Site
- Kansas
  - Hutchinson, Kansas, United States, 67502
    - Recruiting
    - Research Site
  - Kansas City, Kansas, United States, 66112
    - Recruiting
    - Research Site
  - Wichita, Kansas, United States, 67214
    - Recruiting
    - Research Site
- Louisiana
  - Kenner, Louisiana, United States, 70065
    - Withdrawn
    - Research Site
  - Metairie, Louisiana, United States, 70006
    - Recruiting
    - Research Site
  - West Monroe, Louisiana, United States, 71291
    - Recruiting
    - Research Site
- Maryland
  - Bethesda, Maryland, United States, 20889
    - Recruiting
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Withdrawn
    - Research Site
  - Boston, Massachusetts, United States, 02115
    - Recruiting
    - Research Site
  - Braintree, Massachusetts, United States, 02184
    - Not yet recruiting
    - Research Site
  - New Bedford, Massachusetts, United States, 02740
    - Recruiting
    - Research Site
  - Worcester, Massachusetts, United States, 01608
    - Recruiting
    - Research Site
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Recruiting
    - Research Site
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Research Site
  - Garden City, Michigan, United States, 48135
    - Recruiting
    - Research Site
  - Saint Joseph, Michigan, United States, 49085
    - Recruiting
    - Research Site
- Missouri
  - Kansas City, Missouri, United States, 64111
    - Recruiting
    - Research Site
  - Kansas City, Missouri, United States, 64151
    - Recruiting
    - Research Site
  - St Louis, Missouri, United States, 63136
    - Recruiting
    - Research Site
- Nebraska
  - Norfolk, Nebraska, United States, 68701
    - Recruiting
    - Research Site
- Nevada
  - Las Vegas, Nevada, United States, 89109
    - Withdrawn
    - Research Site
- New Jersey
  - Eatontown, New Jersey, United States, 07724
    - Recruiting
    - Research Site
- New York
  - Albany, New York, United States, 12205
    - Recruiting
    - Research Site
  - Buffalo, New York, United States, 14203
    - Recruiting
    - Research Site
  - New York, New York, United States, 10016
    - Recruiting
    - Research Site
- North Carolina
  - Greenville, North Carolina, United States, 27834
    - Recruiting
    - Research Site
  - Hickory, North Carolina, United States, 28601
    - Recruiting
    - Research Site
  - Jacksonville, North Carolina, United States, 28546
    - Recruiting
    - Research Site
  - Kinston, North Carolina, United States, 28504
    - Recruiting
    - Research Site
  - Morehead City, North Carolina, United States, 28557
    - Recruiting
    - Research Site
  - New Bern, North Carolina, United States, 28562
    - Recruiting
    - Research Site
  - Raleigh, North Carolina, United States, 27609
    - Recruiting
    - Research Site
  - Rocky Mount, North Carolina, United States, 27804
    - Recruiting
    - Research Site
  - Sanford, North Carolina, United States, 27330
    - Recruiting
    - Research Site
  - Statesville, North Carolina, United States, 28625
    - Recruiting
    - Research Site
  - Wilmington, North Carolina, United States, 28401
    - Recruiting
    - Research Site
  - Wilmington, North Carolina, United States, 28412
    - Recruiting
    - Research Site
  - Winston-Salem, North Carolina, United States, 27103
    - Recruiting
    - Research Site
- Ohio
  - Canton, Ohio, United States, 44718
    - Recruiting
    - Research Site
  - Cincinnati, Ohio, United States, 45219
    - Recruiting
    - Research Site
  - Cincinnati, Ohio, United States, 45212
    - Recruiting
    - Research Site
  - Columbus, Ohio, United States, 43215
    - Recruiting
    - Research Site
  - Columbus, Ohio, United States, 43210
    - Recruiting
    - Research Site
  - Columbus, Ohio, United States, 43213
    - Recruiting
    - Research Site
- Pennsylvania
  - Bridgeville, Pennsylvania, United States, 15017
    - Recruiting
    - Research Site
  - Butler, Pennsylvania, United States, 16001
    - Recruiting
    - Research Site
  - Exton, Pennsylvania, United States, 19341
    - Recruiting
    - Research Site
  - Media, Pennsylvania, United States, 19063
    - Recruiting
    - Research Site
- Rhode Island
  - East Providence, Rhode Island, United States, 02915
    - Recruiting
    - Research Site
  - East Providence, Rhode Island, United States, 02914
    - Recruiting
    - Research Site
  - Providence, Rhode Island, United States, 02904
    - Suspended
    - Research Site
- South Carolina
  - Charleston, South Carolina, United States, 29414
    - Recruiting
    - Research Site
  - Columbia, South Carolina, United States, 29203
    - Recruiting
    - Research Site
  - Orangeburg, South Carolina, United States, 29118
    - Not yet recruiting
    - Research Site
- Tennessee
  - Chattanooga, Tennessee, United States, 37421
    - Recruiting
    - Research Site
  - Knoxville, Tennessee, United States, 37938
    - Recruiting
    - Research Site
  - Knoxville, Tennessee, United States, 37912
    - Recruiting
    - Research Site
  - Nashville, Tennessee, United States, 37232
    - Recruiting
    - Research Site
- Texas
  - Arlington, Texas, United States, 76015
    - Recruiting
    - Research Site
  - Austin, Texas, United States, 78751
    - Recruiting
    - Research Site
  - Austin, Texas, United States, 78726
    - Recruiting
    - Research Site
  - Austin, Texas, United States, 78735
    - Recruiting
    - Research Site
  - Dallas, Texas, United States, 75246
    - Recruiting
    - Research Site
  - Dallas, Texas, United States, 75230
    - Withdrawn
    - Research Site
  - Dallas, Texas, United States, 75234
    - Recruiting
    - Research Site
  - Houston, Texas, United States, 77004
    - Recruiting
    - Research Site
  - Houston, Texas, United States, 77099
    - Recruiting
    - Research Site
  - Humble, Texas, United States, 77346
    - Recruiting
    - Research Site
  - Lewisville, Texas, United States, 75057
    - Suspended
    - Research Site
  - Pasadena, Texas, United States, 77504
    - Recruiting
    - Research Site
  - Pearland, Texas, United States, 77584
    - Suspended
    - Research Site
  - San Antonio, Texas, United States, 78212
    - Recruiting
    - Research Site
- Utah
  - South Salt Lake, Utah, United States, 84115
    - Recruiting
    - Research Site
- Vermont
  - Burlington, Vermont, United States, 05401
    - Recruiting
    - Research Site
- Virginia
  - Arlington, Virginia, United States, 22205
    - Recruiting
    - Research Site
  - Manassas, Virginia, United States, 20110
    - Recruiting
    - Research Site
  - Newport News, Virginia, United States, 23606
    - Recruiting
    - Research Site
  - Richmond, Virginia, United States, 23249
    - Not yet recruiting
    - Research Site
  - Woodbridge, Virginia, United States, 22192
    - Recruiting
    - Research Site
- Washington
  - Seattle, Washington, United States, 98195
    - Recruiting
    - Research Site
Vietnam
- - Da Nang, Vietnam, 550000
    - Recruiting
    - Research Site
  - Haiphong, Vietnam, 180000
    - Recruiting
    - Research Site
  - Hanoi, Vietnam, 10000
    - Recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 70000
    - Recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Not yet recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Withdrawn
    - Research Site
  - Rach Gia, Vietnam, 920000
    - Not yet recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.
Participants with (a) or (b):
a) eGFR 30-59 mL/min/1.73 m² (local or central laboratory value) AND:
- UACR ≥ 30 mg/g (3.39 mg/mmol) and < 500 mg/g (56.5 mg/mmol) (central laboratory value only), or
- UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or
- UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only).
  (b) eGFR 60-75 mL/min/1.73 m² (local or central laboratory value) AND:
- UACR ≥ 500 mg/g (56.5 mg/mmol) ) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or
- UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only)
[obsolete]
Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit.
Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit.
Participants with:
1. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central laboratory values)
2. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2 (local or central laboratory values)

Exclusion Criteria:

Systolic blood pressure > 180 mmHg, or diastolic BP > 110 mmHg at screening.
Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.
Serum sodium < 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).

4. Participants with T1DM will be excluded, except:

For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that period, and who have experience with ketone monitoring are eligible for inclusion.
For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months, without DKA during the period of dapagliflozin treatment are eligible for inclusion.
5 Uncontrolled T2DM with HbA1c > 10.5% (> 91 mmol/mol) (central or local laboratory values obtained within 3 months prior to screening or at the Screening Visit).
6 New York Heart Association functional HF class IV at screening.
7 Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening heart failure within previous 3 months prior to randomisation.
8 Documented history of adrenal insufficiency.
9 Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
10 Any acute kidney injury within 3 months prior to the Screening Visit.
11 History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).
12 Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baxdrostat/dapagliflozin Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a lower dose of baxdrostat and standard dose dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.	Drug: Baxdrostat/dapagliflozin baxdrostat tablet dapagliflozin tablet Other Names: Baxdrostat CIN-107
Placebo Comparator: Placebo/dapagliflozin Patients will receive one dose of dapagliflozin comparator in combination with matching placebo daily.	Drug: Placebo/dapagliflozin dapagliflozin tablet placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, Heart Failure events(HF), or CV death. Time Frame: Up to 37 months	Time to the first occurrence of any of the components of the composite of: Kidney disease progression ≥ 50% sustained decline in eGFR Onset of kidney failure: Sustained eGFR < 15 mL/min/1.73 m2 or Chronic dialysis treatment or Receiving a kidney transplant or Death with a renal primary cause (death due to kidney failure when dialysis is not given) CV events HF with or without hospitalisation CV death	Up to 37 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure or CV death. Time Frame: Up to 37 months	To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, or CV death.	Up to 37 months
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of kidney failure Time Frame: Up to 37 months	Time to the first occurrence of any of the components of the composite of: • Onset of kidney failure: Sustained eGFR < 15 mL/min/1.73 m2 or Chronic dialysis treatment or Receiving a kidney transplant or Death with a renal primary cause (death due to kidney failure when dialysis is not given)	Up to 37 months
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of MACE (Major Adverse Cardiac Events). Time Frame: Up to 37 months	Time to the first occurrence of any of the components of the composite of: CV (cardiovascular) death, HF (heart failure) with and without hospitalization, Myocardial Infraction, Stroke	Up to 37 months
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of CV (cardiovascular) death. Time Frame: Up to 37 months	Time to the first occurrence of any of the components of the composite of CV (cardiovascular) death	Up to 37 months
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of all-cause death. Time Frame: Up to 37 months	Time to the first occurrence of any of the components of the composite of all-cause death	Up to 37 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the safety and tolerability of baxdrostat/dapagliflozin compared with placebo/dapagliflozin. Time Frame: Up to 37 months	Safety and tolerability will be evaluated in terms of the following endpoints: Occurrence and time to first occurrence of AEs, SAEs, SAEs with outcome death, DAEs, possibly related AEs as assessed by Investigator. Observed values, change from baseline and time to first treatment-emergent abnormality in laboratory parameters. Observed values, change from baseline and time to first treatment-emergent abnormality in vital signs, ECG. Occurrence and time to first occurrence of AESIs: hyperkalaemia, hyponatraemia, and hypotension events that require medical intervention. -Exposure to study treatment will be described	Up to 37 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Dwyer JP, Maklad N, Vedin O, Monyak J, Myte R, Chertow GM, Heerspink HJL, Little DJ. Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2026 Feb 1;37(2):299-311. doi: 10.1681/ASN.0000000849. Epub 2025 Sep 6.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2025

Primary Completion (Estimated)

December 18, 2029

Study Completion (Estimated)

December 18, 2029

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

December 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D6972C00002
2023-506460-14-00 (Registry Identifier: EU CT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Recruiting

A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure. (BaxDuo-Baltic)

Chronic Kidney Disease and Hypertension

United States, Argentina, Taiwan, Thailand, Bulgaria, United Kingdom, Spain, Canada, Ukraine, Turkey (Türkiye), South Korea
AstraZeneca

Active, not recruiting

A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.

Chronic Kidney Disease and Hypertension

United States, Belgium, Germany, Italy, Netherlands, United Kingdom, Denmark, Thailand, Canada, France, Brazil, Japan, Philippines, China, Malaysia, Taiwan, Israel, Spain, Australia, South Africa, Ukraine, Greece, Bulgaria, Serbia, Hungary and more
AstraZeneca

Recruiting

Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin (Prevent-HF)

Heart Failure

China, United States, Canada, Denmark, Germany, Hungary, Israel, Netherlands, Poland, South Africa, Spain, Philippines, Italy, Bulgaria, India, Argentina, Peru, France, Brazil, Malaysia, Taiwan, Thailand, Japan, Greece, Mexico, Vietnam, Sweden and more
AstraZeneca

Completed

Baxdrostat Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Japanese Population

Hypertension

United States
AstraZeneca

Completed

Study to Evaluate the Pharmacokinetics of CIN-107 in Subjects With Varying Degrees of Renal Function

Hypertension

United States
AstraZeneca

Completed

Study With CIN-107 Following Multiple Oral Ascending Doses in Healthy Subjects

Hypertension

United States
AstraZeneca

Completed

Baxdrostat Bioavailability and Bioequivalence Study

Hypertension

United States
AstraZeneca

Completed

Phase 1 PK Study to Evaluate the PK of CIN-107 in Subjects With Hepatic Impairment

Hypertension

United States
AstraZeneca

Completed

A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension (BaxAsia)

Resistant Hypertension | Uncontrolled Hypertension

Vietnam, Philippines, China, Japan, Hong Kong, Australia, Argentina, India, South Korea, Turkey (Türkiye), Russia
AstraZeneca

Completed

A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension (Bax24)

Resistant Hypertension

United States, Spain, Thailand, Vietnam, Philippines, South Africa, Canada, Hungary, Greece, Australia, Germany, Taiwan, Bulgaria, United Kingdom, Poland, Belgium, Saudi Arabia, Czechia, Argentina, Slovakia, Malaysia, Turkey (Türkiye)

A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure (BaxDuo-Pacific)

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Chronic Kidney Disease and Hypertension

Clinical Trials on Baxdrostat/dapagliflozin

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