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.

May 11, 2026 updated by: AstraZeneca

A Phase III, Randomised, Double-Blind Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Chronic Kidney Disease (CKD) Progression in Participants With CKD and High Blood Pressure

The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN.

This study consists of a screening, a 4-week dapagliflozin run-in period for participants untreated with SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin; and approximately 12-week open-label period in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin alone. Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation. Thereafter visits will occur approximately every 4 months, until the 24-month visit at which time baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 12-weeks (approximately), where reassessment of eGFR will occur for the primary efficacy endpoint.

In the event of premature discontinuation of blinded study intervention, participants will continue in the study and receive open-label dapagliflozin monotherapy, unless the participant meets dapagliflozin specific discontinuation criteria, in which case all study interventions will be discontinued.

Study Overview

Status

Active, not recruiting

Conditions

Chronic Kidney Disease and Hypertension

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2554

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 Locations

Argentina
- - Buenos Aires, Argentina, ARG 1425
    - Research Site
  - CABA, Argentina, C1061
    - Research Site
  - CABA, Argentina, C1120AAC
    - Research Site
  - Ciudad Autonoma de Bs As, Argentina, C1013AAB
    - Research Site
  - Ciudad de Buenos Aires, Argentina, C1019ABS
    - Research Site
  - Córdoba, Argentina, X5006CBI
    - Research Site
  - La Plata, Argentina, B1900AVG
    - Research Site
  - Lanus, Argentina, 1824
    - Research Site
  - Mar del Plata, Argentina, 7600
    - Research Site
  - Mar del Plata, Argentina, B7600
    - Research Site
  - Mendoza, Argentina, M5500
    - Research Site
  - San Nicolás, Argentina, B2900DMH
    - Research Site
Australia
- - Birtinya, Australia, 4575
    - Research Site
  - Clayton, Australia, 3168
    - Research Site
  - Darlinghurst, Australia, 2010
    - Research Site
  - Gosford, Australia, 2250
    - Research Site
  - Kogarah, Australia, 2217
    - Research Site
  - Perth, Australia, 6000
    - Research Site
  - St Leonards, Australia, 2065
    - Research Site
  - Wollongong, Australia, 2500
    - Research Site
Belgium
- - Aalst, Belgium, 9300
    - Research Site
  - Bonheiden, Belgium, 2820
    - Research Site
  - Brussels, Belgium, 1200
    - Research Site
  - Ghent, Belgium, 9000
    - Research Site
  - Ieper, Belgium, 8900
    - Research Site
  - Kortrijk, Belgium, 8500
    - Research Site
  - Leuven, Belgium, 3000
    - Research Site
  - Liège, Belgium, 4000
    - Research Site
  - Roeselare, Belgium, 8800
    - Research Site
  - Ronse, Belgium, 9600
    - Research Site
Brazil
- - Belém, Brazil, 66073-005
    - Research Site
  - Campina Grande do Sul, Brazil, 83.430-000
    - Research Site
  - Campinas, Brazil, 13060-080
    - Research Site
  - Campinas, Brazil, 13060-904
    - Research Site
  - Curitiba, Brazil, 80230-130
    - Research Site
  - Curitiba, Brazil, 80440-020
    - Research Site
  - Fortaleza, Brazil, 60175-047
    - Research Site
  - Joinville, Brazil, 89227-680
    - Research Site
  - Maringá, Brazil, 87060-040
    - Research Site
  - Porto Alegre, Brazil, 90035-074
    - Research Site
  - Porto Alegre, Brazil, 90160-093
    - Research Site
  - São José do Rio Preto, Brazil, 15090-000
    - Research Site
  - São Paulo, Brazil, 04012-180
    - Research Site
  - São Paulo, Brazil, 04038-031
    - Research Site
  - São Paulo, Brazil, 05403-9000
    - Research Site
Bulgaria
- - Dupnitsa, Bulgaria, 2600
    - Research Site
  - Gotse Delchev, Bulgaria, 2900
    - Research Site
  - Kozloduy, Bulgaria, 3320
    - Research Site
  - Lom, Bulgaria, 3600
    - Research Site
  - Pleven, Bulgaria, 5800
    - Research Site
  - Plovdiv, Bulgaria, 4000
    - Research Site
  - Plovdiv, Bulgaria, 4004
    - Research Site
  - Plovdiv, Bulgaria, 4001
    - Research Site
  - Sandanski, Bulgaria, 2800
    - Research Site
  - Sliven, Bulgaria, 8800
    - Research Site
  - Stara Zagora, Bulgaria, 6000
    - Research Site
  - Veliko Tarnovo, Bulgaria, 5000
    - Research Site
  - Yambol, Bulgaria, 8600
    - Research Site
Canada
- - Saint John, Canada, E2L 4L2
    - Research Site
- Alberta
  - Edmonton, Alberta, Canada, T6G 2G3
    - Research Site
- British Columbia
  - Vancouver, British Columbia, Canada, V5Y 3W2
    - Research Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R2V 3M3
    - Research Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V7
    - Research Site
  - Sydney, Nova Scotia, Canada, B1P 1P3
    - Research Site
- Ontario
  - Brampton, Ontario, Canada, L6S 0C6
    - Research Site
  - Concord, Ontario, Canada, L4K 4M2
    - Research Site
  - London, Ontario, Canada, N6A 5A5
    - Research Site
  - Oshawa, Ontario, Canada, L1G 2B9
    - Research Site
  - Stoney Creek, Ontario, Canada, L8J 3W2
    - Research Site
  - Toronto, Ontario, Canada, M5C 2T2
    - Research Site
  - Toronto, Ontario, Canada, M4G 3E8
    - Research Site
  - Waterloo, Ontario, Canada, N2T 0C1
    - Research Site
- Quebec
  - Laval, Quebec, Canada, H7T 2P5
    - Research Site
  - Montreal, Quebec, Canada, H4J 1C5
    - Research Site
  - Montreal, Quebec, Canada, H2X 0A9
    - Research Site
  - Québec, Quebec, Canada, G1R 2J6
    - Research Site
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - Research Site
Chile
- - Araucania, Chile, 4781151
    - Research Site
  - Santiago, Chile, 7500922
    - Research Site
  - Valdivia, Chile, 5090000
    - Research Site
  - Victoria, Chile, 4720097
    - Research Site
China
- - Baotou, China, 014010
    - Research Site
  - Beijing, China, 100034
    - Research Site
  - Beijing, China, 100029
    - Research Site
  - Beijing, China, 100035
    - Research Site
  - Beijing, China, 100191
    - Research Site
  - Beijing, China, 102218
    - Research Site
  - Changchun, China, 130041
    - Research Site
  - Changsha, China, 410013
    - Research Site
  - Changzhou, China, 272100
    - Research Site
  - Chengdu, China, 610072
    - Research Site
  - Chongqing, China, 402260
    - Research Site
  - Dongguan, China, 523009
    - Research Site
  - Foshan, China, 528000
    - Research Site
  - Guangzhou, China, 510630
    - Research Site
  - Guangzhou, China, 510800
    - Research Site
  - Guiyang, China, 550044
    - Research Site
  - Haikou, China, 570311
    - Research Site
  - Hangzhou, China, 310014
    - Research Site
  - Hengyang, China, 421001
    - Research Site
  - Huai'an, China, 223300
    - Research Site
  - Lanzhou, China, 730000
    - Research Site
  - Nanchang, China, 330008
    - Research Site
  - Nanjing, China, 210009
    - Research Site
  - Ningbo, China, 315010
    - Research Site
  - Panjin, China, 124009
    - Research Site
  - Pingxiang, China, 337055
    - Research Site
  - Sanya, China, 572000
    - Research Site
  - Shanghai, China, 200240
    - Research Site
  - Shenyang, China, 110004
    - Research Site
  - Shenzhen, China, 518036
    - Research Site
  - Wuhan, China, 430060
    - Research Site
  - Wuhan, China, 430010
    - Research Site
  - Wuxi, China, 214023
    - Research Site
  - Xi'an, China, 710061
    - Research Site
  - Xiamen, China, 361004
    - Research Site
  - Yantai, China, 264000
    - Research Site
  - Yinchuan, China, 750004
    - Research Site
  - Zhengzhou, China, 450052
    - Research Site
  - Ürümqi, China, 831118
    - Research Site
Czechia
- - Frýdek-Místek, Czechia, 738 01
    - Research Site
  - Jilemnice, Czechia, 514 01
    - Research Site
  - Krnov, Czechia, 794 01
    - Research Site
  - Náchod, Czechia, 547 01
    - Research Site
  - Olomouc, Czechia, 772 00
    - Research Site
  - Police nad Metují, Czechia, 549 54
    - Research Site
  - Prague, Czechia, 140 00
    - Research Site
  - Prague, Czechia, 104 00
    - Research Site
  - Prague, Czechia, 160 00
    - Research Site
  - Třebíč, Czechia, 674 01
    - Research Site
Denmark
- - Aalborg, Denmark, 9000
    - Research Site
  - Aarhus, Denmark, 8200
    - Research Site
  - Copenhagen E, Denmark, 2100
    - Research Site
  - Esbjerg, Denmark, 6700
    - Research Site
  - Herlev, Denmark, 2730
    - Research Site
  - Herning, Denmark, 7400
    - Research Site
  - Holbæk, Denmark, 4300
    - Research Site
France
- - Amiens, France, 80054
    - Research Site
  - Annonay, France, 07103
    - Research Site
  - Bois-Guillaume, France, 76230
    - Research Site
  - Bordeaux, France, 33076
    - Research Site
  - Boulogne-Billancourt, France, 92104
    - Research Site
  - Brest, France, 29200
    - Research Site
  - Clermont-Ferrand, France, 63003
    - Research Site
  - La Roche-sur-Yon, France, 85925
    - Research Site
  - Le Puy-en-Velay, France, 43000
    - Research Site
  - Lille, France, 59037
    - Research Site
  - Marseille, France, 13385
    - Research Site
  - Nîmes, France, 30029
    - Research Site
  - Paris, France, 75015
    - Research Site
  - Paris, France, 75020
    - Research Site
  - Poitiers, France, 86021
    - Research Site
  - Quimper, France, 29000
    - Research Site
  - Sarcelles, France, 95200
    - Research Site
  - Toulouse, France, 31400
    - Research Site
  - Tours, France, 37000
    - Research Site
  - Valenciennes, France, 59300
    - Research Site
  - Vandœuvre-lès-Nancy, France, 54511
    - Research Site
Germany
- - Aachen, Germany, 52074
    - Research Site
  - Amberg, Germany, 92224
    - Research Site
  - Bad Oeynhausen, Germany, 32545
    - Research Site
  - Berlin, Germany, 12203
    - Research Site
  - Berlin, Germany, 13353
    - Research Site
  - Berlin, Germany, 13187
    - Research Site
  - Bochum, Germany, 44787
    - Research Site
  - Dresden, Germany, 1307
    - Research Site
  - Essen, Germany, 45355
    - Research Site
  - Falkensee, Germany, 14612
    - Research Site
  - Hamburg, Germany, 22607
    - Research Site
  - Herne, Germany, 44625
    - Research Site
  - Leipzig, Germany, 04179
    - Research Site
  - Mainz, Germany, 55131
    - Research Site
  - München, Germany, 81675
    - Research Site
  - Münster, Germany, 48145
    - Research Site
  - Nuremberg, Germany, 90443
    - Research Site
  - Oldenburg, Germany, 23758
    - Research Site
  - Reinfeld (Holstein), Germany, 23858
    - Research Site
  - Ulm, Germany, 89081
    - Research Site
  - Völklingen, Germany, 66333
    - Research Site
Greece
- - Alexandroupoli, Greece, 68100
    - Research Site
  - Athens, Greece, 11527
    - Research Site
  - Heraklion, Greece, 71500
    - Research Site
  - Ioannina, Greece, 45500
    - Research Site
  - Pátrai, Greece, 26504
    - Research Site
  - Thessaloniki, Greece, 54636
    - Research Site
  - Thessaloniki, Greece, 54642
    - Research Site
Hungary
- - Budapest, Hungary, 1036
    - Research Site
  - Budapest, Hungary, 1132
    - Research Site
  - Békéscsaba, Hungary, 5600
    - Research Site
  - Kecskemét, Hungary, 6000
    - Research Site
  - Nyíregyháza, Hungary, 4400
    - Research Site
  - Pécs, Hungary, 7635
    - Research Site
  - Pécs, Hungary, 7624
    - Research Site
  - Siófok, Hungary, 8600
    - Research Site
  - Székesfehérvár, Hungary, 8000
    - Research Site
India
- - Bangalore, India, 560 092
    - Research Site
  - Belagavi, India, 590010
    - Research Site
  - Calicut, India, 673 008
    - Research Site
  - Chennai, India, 600037
    - Research Site
  - Coimbatore, India, 641018
    - Research Site
  - Dehradun, India, 248001
    - Research Site
  - Hyderabad, India, 500038
    - Research Site
  - Kolkata, India, 700020
    - Research Site
  - Madurai, India, 625107
    - Research Site
  - New Delhi, India, 110017
    - Research Site
  - New Delhi, India, 110029
    - Research Site
  - Pune, India, 411013
    - Research Site
  - Vijayawada, India, 520 008
    - Research Site
Israel
- - Ashkelon, Israel, 78278
    - Research Site
  - Haifa, Israel, 34362
    - Research Site
  - Jerusalem, Israel, 9372212
    - Research Site
  - Kfar Saba, Israel, 44410
    - Research Site
  - Petah Tikva, Israel, 49372
    - Research Site
  - Ramat Gan, Israel, 52621
    - Research Site
  - Rehovot, Israel, 76100
    - Research Site
  - Tel Aviv, Israel, 6423906
    - Research Site
Italy
- - Bologna, Italy, 40138
    - Research Site
  - Catanzaro, Italy, 88100
    - Research Site
  - Chiavari, Italy, 16034
    - Research Site
  - Desio, Italy, 20832
    - Research Site
  - Milan, Italy, 20142
    - Research Site
  - Naples, Italy, 80131
    - Research Site
  - Parma, Italy, 43126
    - Research Site
  - Rozzano, Italy, 20089
    - Research Site
  - San Giovanni Rotondo, Italy, 71013
    - Research Site
  - Torino, Italy, 10126
    - Research Site
Japan
- - Chūōku, Japan, 103-0027
    - Research Site
  - Chūōku, Japan, 103-0002
    - Research Site
  - Chūōku, Japan, 103-0028
    - Research Site
  - Daito-shi, Japan, 574-0074
    - Research Site
  - Fujisawa-shi, Japan, 251-8550
    - Research Site
  - Fukuoka, Japan, 815-8555
    - Research Site
  - Hiroshima, Japan, 732-0057
    - Research Site
  - Hiroshima, Japan, 730-8518
    - Research Site
  - Ina-shi, Japan, 396-8555
    - Research Site
  - Kamakura-shi, Japan, 247-8533
    - Research Site
  - Kamakura-shi, Japan, 247-0056
    - Research Site
  - Kasugai-shi, Japan, 486-8510
    - Research Site
  - Kawaguchi, Japan, 332-0015
    - Research Site
  - Kofu, Japan, 400-8506
    - Research Site
  - Kumagaya-shi, Japan, 360-0197
    - Research Site
  - Kurume-shi, Japan, 830-0011
    - Research Site
  - Kyoto, Japan, 606-8507
    - Research Site
  - Marugame-shi, Japan, 763-8502
    - Research Site
  - Matsuyama, Japan, 790-0024
    - Research Site
  - Nagoya, Japan, 457-8511
    - Research Site
  - Naka, Japan, 311-0113
    - Research Site
  - Nishinomiya-Shi, Japan, 662-0918
    - Research Site
  - Obihiro-shi, Japan, 080-0848
    - Research Site
  - Osaka, Japan, 553-0003
    - Research Site
  - Sakaishi, Japan, 593-8304
    - Research Site
  - Sapporo, Japan, 064-8570
    - Research Site
  - Sendai, Japan, 980-8574
    - Research Site
  - Shinjyuku-ku, Japan, 160-0022
    - Research Site
  - Shizuoka, Japan, 421-0117
    - Research Site
  - Takatsuki-shi, Japan, 569-8686
    - Research Site
  - Toride-shi, Japan, 302-0022
    - Research Site
  - Toyota-Shi, Japan, 471-8513
    - Research Site
  - Tsu, Japan, 514-8507
    - Research Site
  - Tsu, Japan, 514-1101
    - Research Site
  - Ueda-shi, Japan, 386-8610
    - Research Site
  - Urayasu, Japan, 279-0001
    - Research Site
  - Yaizu-shi, Japan, 425-8505
    - Research Site
  - Yokohama, Japan, 236-0004
    - Research Site
  - Ōita, Japan, 870-0033
    - Research Site
Malaysia
- - Klang, Malaysia, 41200
    - Research Site
  - Kota Kinabalu, Malaysia, 88200
    - Research Site
  - Kuala Lumpur, Malaysia, 59100
    - Research Site
  - Kuala Lumpur, Malaysia, 50586
    - Research Site
  - Kuantan, Malaysia, 25200
    - Research Site
  - Seremban, Malaysia, 70300
    - Research Site
  - Taiping, Malaysia, 34000
    - Research Site
Netherlands
- - Alkmaar, Netherlands, 1815 JD
    - Research Site
  - Amersfoort, Netherlands, 3813 TZ
    - Research Site
  - Dordrecht, Netherlands, 3318 AT
    - Research Site
  - Hardenberg, Netherlands, 7772 SE
    - Research Site
  - Harderwijk, Netherlands, 3844 DG
    - Research Site
  - Hilversum, Netherlands, 1212 VG
    - Research Site
  - Utrecht, Netherlands, 3584 CX
    - Research Site
Peru
- - Arequipa, Peru, AREQUIPA01
    - Research Site
  - Chorrillos, Peru, Lima 9
    - Research Site
  - Lima, Peru, LIMA 01
    - Research Site
  - Lima, Peru, 15046
    - Research Site
  - Lima, Peru, 15036
    - Research Site
  - Lima, Peru, 15088
    - Research Site
  - Piura, Peru, 20001
    - Research Site
Philippines
- - Cebu City, Philippines, 6000
    - Research Site
  - Davao City, Philippines, PH-8000
    - Research Site
  - Iloilo City, Philippines, 5000
    - Research Site
  - Laguna, Philippines, 4024
    - Research Site
  - Manila, Philippines, 1000
    - Research Site
  - Quezon City, Philippines, 1101
    - Research Site
Poland
- - Chrzanów, Poland, 32-500
    - Research Site
  - Gdynia, Poland, 81-157
    - Research Site
  - Krakow, Poland, 31-261
    - Research Site
  - Krakow, Poland, 30-688
    - Research Site
  - Krakow, Poland, 31-513
    - Research Site
  - Krakow, Poland, 31-156
    - Research Site
  - Krakow, Poland, 31-801
    - Research Site
  - Lodz, Poland, 90-549
    - Research Site
  - Lodz, Poland, 92-213
    - Research Site
  - Lodz, Poland, 91-211
    - Research Site
  - Lodz, Poland, 91-363
    - Research Site
  - Lublin, Poland, 20-090
    - Research Site
  - Olsztyn, Poland, 10-165
    - Research Site
  - Poznan, Poland, 60-355
    - Research Site
  - Poznan, Poland, 61-848
    - Research Site
  - Rzeszów, Poland, 35-055
    - Research Site
  - Szczecin, Poland, 70-111
    - Research Site
  - Tczew, Poland, 83-110
    - Research Site
  - Warsaw, Poland, 03-291
    - Research Site
  - Wroclaw, Poland, 50-981
    - Research Site
  - Wroclaw, Poland, 50-381
    - Research Site
  - Wroclaw, Poland, 53-673
    - Research Site
  - Żywiec, Poland, 34-300
    - Research Site
Romania
- - Bucharest, Romania, 022328
    - Research Site
  - Bucharest, Romania, 014461
    - Research Site
  - Bucharest, Romania, 010731
    - Research Site
  - Bucharest, Romania, 040883
    - Research Site
  - Cluj-Napoca, Romania, 400347
    - Research Site
  - Iași, Romania, 700503
    - Research Site
  - Oradea, Romania, 410469
    - Research Site
  - Timișoara, Romania, 300723
    - Research Site
  - Târgu Mureş, Romania, 540136
    - Research Site
Saudi Arabia
- - Dammam, Saudi Arabia, 31444
    - Research Site
  - Riyadh, Saudi Arabia, 11426
    - Research Site
  - Riyadh, Saudi Arabia, 11462
    - Research Site
  - Riyadh, Saudi Arabia, 11525
    - Research Site
  - Riyadh, Saudi Arabia, 12713
    - Research Site
Serbia
- - Belgrade, Serbia, 11000
    - Research Site
  - Belgrade, Serbia, 11120
    - Research Site
  - Kragujevac, Serbia, 34000
    - Research Site
  - Niš, Serbia, 18000
    - Research Site
  - Novi Sad, Serbia, 21000
    - Research Site
Slovakia
- - Banská Bystrica, Slovakia, 974 01
    - Research Site
  - Lučenec, Slovakia, 984 01
    - Research Site
  - Martin, Slovakia, 03659
    - Research Site
  - Myjava, Slovakia, 90701
    - Research Site
  - Nitra, Slovakia, 949 01
    - Research Site
  - Nitra, Slovakia, 949 11
    - Research Site
  - Prešov, Slovakia, 080 01
    - Research Site
  - Púchov, Slovakia, 020 01
    - Research Site
  - Rožňava, Slovakia, 048 01
    - Research Site
  - Trnava, Slovakia, 91708
    - Research Site
  - Žilina, Slovakia, 010 01
    - Research Site
South Africa
- - Benoni, South Africa, 1501
    - Research Site
  - Cape Town, South Africa, 7570
    - Research Site
  - Cape Town, South Africa, 7925
    - Research Site
  - Durban, South Africa, 4091
    - Research Site
  - KwaDukuza, South Africa, 4450
    - Research Site
  - Lenasia, South Africa, 1827
    - Research Site
  - Midrand, South Africa, 1685
    - Research Site
  - Newton, South Africa, 2113
    - Research Site
  - Parow, South Africa, 7505
    - Research Site
South Korea
- - Ansan-si, South Korea, 15355
    - Research Site
  - Anyang-si, South Korea, 14068
    - Research Site
  - Busan, South Korea, 49241
    - Research Site
  - Cheonan-si, South Korea, 31151
    - Research Site
  - Daejeon, South Korea, 301-723
    - Research Site
  - Goyang-si, South Korea, 10380
    - Research Site
  - Gwangju, South Korea, 61469
    - Research Site
  - Seoul, South Korea, 03722
    - Research Site
  - Seoul, South Korea, 06273
    - Research Site
  - Seoul, South Korea, 03312
    - Research Site
  - Seoul, South Korea, 03181
    - Research Site
  - Seoul, South Korea, 07061
    - Research Site
  - Seoul, South Korea, 04401
    - Research Site
  - Uijeongbu-si, South Korea, 11765
    - Research Site
  - Wŏnju, South Korea, 26426
    - Research Site
  - Yangsan, South Korea, 50612
    - Research Site
Spain
- - A Coruña, Spain, 15006
    - Research Site
  - Almería, Spain, 4009
    - Research Site
  - Badalona, Spain, 08916
    - Research Site
  - L'Hospitalet de Llobregat, Spain, 08907
    - Research Site
  - Lugo, Spain, 27004
    - Research Site
  - Madrid, Spain, 28040
    - Research Site
  - Málaga, Spain, 29010
    - Research Site
  - Palma deMallorca, Spain, 07010
    - Research Site
  - Pamplona, Spain, 31008
    - Research Site
  - Seville, Spain, 41950
    - Research Site
  - Valencia, Spain, 46010
    - Research Site
Sweden
- - Gothenburg, Sweden, 413 46
    - Research Site
  - Gävle, Sweden, 80188
    - Research Site
  - Linköping, Sweden, 58185
    - Research Site
  - Rättvik, Sweden, 79530
    - Research Site
  - Stockholm, Sweden, 141 86
    - Research Site
  - Stockholm, Sweden, 18288
    - Research Site
  - Uppsala, Sweden, 751 85
    - Research Site
Taiwan
- - Kaohsiung City, Taiwan, 80756
    - Research Site
  - Kaohsiung City, Taiwan, 81362
    - Research Site
  - New Taipei City, Taiwan, 220
    - Research Site
  - Taichung, Taiwan, 40447
    - Research Site
  - Taichung, Taiwan, 402
    - Research Site
  - Taichung, Taiwan, 433004
    - Research Site
  - Taipei, Taiwan, 10002
    - Research Site
  - Taipei, Taiwan, 112
    - Research Site
  - Taipei, Taiwan, 110
    - Research Site
  - Taoyuan, Taiwan, 33305
    - Research Site
  - Yung Kang City, Taiwan, 71044
    - Research Site
Thailand
- - Bangkok, Thailand, 10330
    - Research Site
  - Bangkok, Thailand, 10700
    - Research Site
  - Chiang Mai, Thailand, 50200
    - Research Site
  - Hat Yai, Thailand, 90110
    - Research Site
  - Muang, Thailand, 40002
    - Research Site
  - Phutthamonthon, Thailand, 73170
    - Research Site
  - Ratchathewi, Thailand, 10400
    - Research Site
  - Ubonratchathani, Thailand, 34000
    - Research Site
Turkey (Türkiye)
- - Adana, Turkey (Türkiye), 01060
    - Research Site
  - Adapazarı, Turkey (Türkiye), 54100
    - Research Site
  - Afyonkarahisar, Turkey (Türkiye), 03030
    - Research Site
  - Ankara, Turkey (Türkiye), 06230
    - Research Site
  - Antalya, Turkey (Türkiye), 07059
    - Research Site
  - Bursa, Turkey (Türkiye), 16059
    - Research Site
  - Istanbul, Turkey (Türkiye), 34890
    - Research Site
  - Kahramanmaraş, Turkey (Türkiye), 46100
    - Research Site
  - Kayseri, Turkey (Türkiye), 38039
    - Research Site
  - Kocaeli, Turkey (Türkiye), 41380
    - Research Site
Ukraine
- - Chernivtsі, Ukraine, 58002
    - Research Site
  - Ivano-Frankivsk, Ukraine, 76000
    - Research Site
  - Kyiv, Ukraine, 01601
    - Research Site
  - Kyiv, Ukraine, 04050
    - Research Site
  - Kyiv, Ukraine, 03037
    - Research Site
  - Kyiv, Ukraine, 03057
    - Research Site
  - Kyiv, Ukraine, 02081
    - Research Site
  - Ternopil, Ukraine, 46001
    - Research Site
  - Ternopil, Ukraine, 46000
    - Research Site
  - Uzhhorod, Ukraine, 88018
    - Research Site
  - Vinnytsia, Ukraine, 21029
    - Research Site
  - Vinnytsia, Ukraine, 21018
    - Research Site
  - Vinnytsia, Ukraine, 21009
    - Research Site
  - Vinnytsia, Ukraine, 21001
    - Research Site
United Kingdom
- - Bristol, United Kingdom, BS105NB
    - Research Site
  - Cambridge, United Kingdom, CB2 0XY
    - Research Site
  - Dundee, United Kingdom, DD1 9SY
    - Research Site
  - Glasgow, United Kingdom, G51 4TF
    - Research Site
  - Harrow, United Kingdom, HA3 7LT
    - Research Site
  - Hounslow, United Kingdom, TW4 7NR
    - Research Site
  - Leicester, United Kingdom, Le5 4PW
    - Research Site
  - Liverpool, United Kingdom, L9 7AL
    - Research Site
  - London, United Kingdom, SE5 9RJ
    - Research Site
  - London, United Kingdom, EC1A 2BE
    - Research Site
  - Newcastle-under-Lyme, United Kingdom, ST4 6QG
    - Research Site
  - Nottingham, United Kingdom, NG5 1PB
    - Research Site
  - Wolverhampton, United Kingdom, WV10 0QP
    - Research Site
United States
- Alabama
  - Fairhope, Alabama, United States, 36532
    - Research Site
- Arizona
  - Phoenix, Arizona, United States, 85016
    - Research Site
  - Surprise, Arizona, United States, 85374
    - Research Site
  - Tucson, Arizona, United States, 85710
    - Research Site
- Arkansas
  - Searcy, Arkansas, United States, 72143
    - Research Site
- California
  - Beverly Hills, California, United States, 90211
    - Research Site
  - Canyon Country, California, United States, 91351
    - Research Site
  - Fremont, California, United States, 94538
    - Research Site
  - Fullerton, California, United States, 92835
    - Research Site
  - Lincoln, California, United States, 95648
    - Research Site
  - Los Alamitos, California, United States, 90720
    - Research Site
  - San Francisco, California, United States, 94110
    - Research Site
  - Stanford, California, United States, 94305
    - Research Site
  - Tarzana, California, United States, 91356
    - Research Site
- Colorado
  - Arvada, Colorado, United States, 80002
    - Research Site
  - Denver, Colorado, United States, 80220
    - Research Site
- Connecticut
  - New Britain, Connecticut, United States, 06051
    - Research Site
- Florida
  - Boca Raton, Florida, United States, 33487
    - Research Site
  - Boynton Beach, Florida, United States, 33435
    - Research Site
  - Edgewater, Florida, United States, 32132
    - Research Site
  - Fort Lauderdale, Florida, United States, 33316
    - Research Site
  - Hialeah, Florida, United States, 33012
    - Research Site
  - Hollywood, Florida, United States, 33021
    - Research Site
  - Jacksonville, Florida, United States, 32204
    - Research Site
  - Jacksonville Beach, Florida, United States, 32250
    - Research Site
  - Lake City, Florida, United States, 32055
    - Research Site
  - Lake Worth, Florida, United States, 33467
    - Research Site
  - Melbourne, Florida, United States, 32901
    - Research Site
  - Miami, Florida, United States, 33165
    - Research Site
  - Miami Lakes, Florida, United States, 33014
    - Research Site
  - New Port Richey, Florida, United States, 34652
    - Research Site
  - Ocoee, Florida, United States, 34761
    - Research Site
  - Orlando, Florida, United States, 32806
    - Research Site
  - Orlando, Florida, United States, 32808
    - Research Site
  - Port Charlotte, Florida, United States, 33952
    - Research Site
  - Port Orange, Florida, United States, 32127
    - Research Site
  - Riverview, Florida, United States, 33578
    - Research Site
  - Winter Haven, Florida, United States, 33880
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30344
    - Research Site
  - Conyers, Georgia, United States, 30094
    - Research Site
  - Macon, Georgia, United States, 31210
    - Research Site
- Illinois
  - Champaign, Illinois, United States, 61822
    - Research Site
  - Hazel Crest, Illinois, United States, 60429
    - Research Site
  - Huntley, Illinois, United States, 60142
    - Research Site
  - Rockford, Illinois, United States, 61107
    - Research Site
- Indiana
  - Evansville, Indiana, United States, 47714
    - Research Site
  - Fort Wayne, Indiana, United States, 46804
    - Research Site
- Kansas
  - Hutchinson, Kansas, United States, 67502
    - Research Site
  - Wichita, Kansas, United States, 67214
    - Research Site
- Maryland
  - Bethesda, Maryland, United States, 20889
    - Research Site
  - Lanham, Maryland, United States, 20706
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Research Site
  - Boston, Massachusetts, United States, 02114
    - Research Site
  - New Bedford, Massachusetts, United States, 02740
    - Research Site
- Michigan
  - Detroit, Michigan, United States, 48202
    - Research Site
  - Pontiac, Michigan, United States, 48341
    - Research Site
  - Saint Joseph, Michigan, United States, 49085
    - Research Site
- Missouri
  - City of Saint Peters, Missouri, United States, 63376
    - Research Site
  - Kansas City, Missouri, United States, 64111
    - Research Site
  - Kansas City, Missouri, United States, 64128
    - Research Site
  - Kansas City, Missouri, United States, 64151
    - Research Site
  - St Louis, Missouri, United States, 63136
    - Research Site
- New Jersey
  - Eatontown, New Jersey, United States, 07724
    - Research Site
- New York
  - Binghamton, New York, United States, 13905
    - Research Site
  - Manhasset, New York, United States, 11030
    - Research Site
  - Middletown, New York, United States, 10940
    - Research Site
  - New York, New York, United States, 10016
    - Research Site
  - Niagara Falls, New York, United States, 14304
    - Research Site
  - Orchard Park, New York, United States, 14127
    - Research Site
  - Rockville Centre, New York, United States, 11570
    - Research Site
- North Carolina
  - Greenville, North Carolina, United States, 27834
    - Research Site
  - Jacksonville, North Carolina, United States, 28546
    - Research Site
  - New Bern, North Carolina, United States, 28562
    - Research Site
  - Statesville, North Carolina, United States, 28625
    - Research Site
  - Wilmington, North Carolina, United States, 28401
    - Research Site
  - Wilmington, North Carolina, United States, 28412
    - Research Site
- Ohio
  - Columbus, Ohio, United States, 43215
    - Research Site
  - Columbus, Ohio, United States, 43213
    - Research Site
  - Maumee, Ohio, United States, 43537
    - Research Site
- Pennsylvania
  - Chester, Pennsylvania, United States, 19013
    - Research Site
  - Langhorne, Pennsylvania, United States, 19047
    - Research Site
  - Uniontown, Pennsylvania, United States, 15401
    - Research Site
- Rhode Island
  - East Providence, Rhode Island, United States, 02914
    - Research Site
  - East Providence, Rhode Island, United States, 02915
    - Research Site
  - Providence, Rhode Island, United States, 02904
    - Research Site
- South Carolina
  - Charleston, South Carolina, United States, 29414
    - Research Site
  - Columbia, South Carolina, United States, 29203
    - Research Site
- South Dakota
  - Sioux Falls, South Dakota, United States, 57104
    - Research Site
- Tennessee
  - Chattanooga, Tennessee, United States, 37421
    - Research Site
  - Memphis, Tennessee, United States, 38105
    - Research Site
  - Memphis, Tennessee, United States, 38115
    - Research Site
- Texas
  - Arlington, Texas, United States, 76015
    - Research Site
  - Austin, Texas, United States, 78751
    - Research Site
  - Austin, Texas, United States, 78726
    - Research Site
  - Dallas, Texas, United States, 75246
    - Research Site
  - Dallas, Texas, United States, 75230
    - Research Site
  - Houston, Texas, United States, 77004
    - Research Site
  - Houston, Texas, United States, 77084
    - Research Site
  - Houston, Texas, United States, 77099
    - Research Site
  - Houston, Texas, United States, 77040
    - Research Site
  - Humble, Texas, United States, 77338
    - Research Site
  - Lewisville, Texas, United States, 75057
    - Research Site
  - Odessa, Texas, United States, 79761
    - Research Site
  - Pasadena, Texas, United States, 77504
    - Research Site
  - San Antonio, Texas, United States, 78212
    - Research Site
  - San Antonio, Texas, United States, 78231
    - Research Site
- Utah
  - Salt Lake City, Utah, United States, 84132
    - Research Site
  - South Salt Lake, Utah, United States, 84115
    - Research Site
- Vermont
  - Burlington, Vermont, United States, 05401
    - Research Site
- Virginia
  - Arlington, Virginia, United States, 22205
    - Research Site
  - Manassas, Virginia, United States, 20110
    - Research Site
  - Newport News, Virginia, United States, 23606
    - Research Site
  - Salem, Virginia, United States, 24153
    - Research Site
  - Woodbridge, Virginia, United States, 22192
    - Research Site
Vietnam
- - Can Tho, Vietnam, 900000
    - Research Site
  - Can Tho, Vietnam, 920000
    - Research Site
  - Da Nang, Vietnam, 550000
    - Research Site
  - Haiphong, Vietnam, 180000
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Research Site
  - Ho Chi Minh City, Vietnam, 70000
    - Research Site
  - Hochiminh City, Vietnam, 700000
    - 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 old, or older, at the time of signing the informed consent.
Participants with CKD and eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening
Urine albumin creatinine ratio > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) at screening
Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit
Stable and maximum tolerated dose of an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to Screening Visit
Central laboratory serum potassium must meet the following criteria at the Screening Visit, based on screening eGFR:
- for participants with screening eGFR ≥ 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.8 mmol/L at the Screening Visit
- for participants with screening eGFR < 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.5 mmol/L at the Screening Visit

Exclusion Criteria:

Systolic blood pressure > 180 mmHg, or DBP > 110 mmHg at screening.
Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.
Serum sodium < 135 mmol/L at the Screening Visit, determined as per central laboratory.
Diabetes mellitus:
(a) T1DM at Screening Visit: (i) 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.
(ii) 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.
(b) Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91 mmol/mol).
New York Heart Association functional HF class IV at screening.
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.
Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
Any acute kidney injury within 3 months prior to the Screening Visit
History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).
History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2 inhibitor (eg, empagliflozin) or ASI.
Any clinical condition requiring systemic immunosuppression therapy other than stable maintenance therapy for at least 3 months prior to Visit 1.
Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone), potassium-sparing diuretics (such as triamterene or amiloride), or potassium binders (such as sodium zirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate) within 4 weeks prior to screening.

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 dose of baxdrostat lower dose and 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
Active Comparator: Dapagliflozin Patients will receive one dose of dapagliflozin (active comparator) in combination with placebo matching baxdrostat daily	Drug: Dapagliflozin in combination with placebo dapagliflozin tablet placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR over time. Time Frame: Baseline - 2 years + 12 weeks	Change from baseline in eGFR to post treatment.	Baseline - 2 years + 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing UACR (urine albumin-creatinine ratio). Time Frame: Baseline -16 weeks	Change from baseline in UACR	Baseline -16 weeks
To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing SBP. Time Frame: Baseline -16 weeks	Change from baseline in systolic BP (blood pressure).	Baseline -16 weeks
To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows the rate of kidney function decline after the hemodynamically-mediated acute effect on GFR (Glomerular Filtration Rate). Time Frame: 8 weeks following randomisation to end of treatment	Change in eGFR from following randomisation.	8 weeks following randomisation to end of treatment
To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone in reducing the risk of MACE Time Frame: Baseline - 24 months	Time to the first occurrence of any of the components of the composite of: CV death HF with and without hospitalization MI Stroke	Baseline - 24 months
To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows CKD progression and reduces the risk of ESKD (End-stage kidney disease). Time Frame: baseline - 2 years + 12 weeks	Kidney hierarchical composite endpoint.* *Defined as the most severe outcome of the following: 1. Death; 2. KFRT (chronic dialysis or kidney transplant); 3. Sustained GFR < 15 mL/min/1.73 m2; 4. Sustained GFR decline from baseline of ≥ 57%; 5 Sustained GFR decline from baseline of ≥ 50%; or 6. individual change from baseline to post-treatment eGFR if none of the outcomes occurred.	baseline - 2 years + 12 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Adverse Events - Number of participants with Adverse Events Time Frame: Baseline - 24 months	Baseline - 24 months
Clinical Laboratory - Number of participants with Abnormal clinical laboratory measurements Time Frame: Baseline - 24 months	Baseline - 24 months
Vital Signs - Number of participants with Abnormal vital signs Time Frame: Baseline - 24 months	Baseline - 24 months
Electrocardiogram- Number of Participants With Abnormal ECG Time Frame: Baseline - 24 months	Baseline - 24 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 29, 2024

Primary Completion (Estimated)

February 24, 2028

Study Completion (Estimated)

February 24, 2028

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D6972C00003
2023-506457-38-00 (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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

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

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations