Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)

April 22, 2024 updated by: AstraZeneca

A Phase III, Randomised, Multicentre, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin Alone in Participants With Chronic Kidney Disease and High Proteinuria

This is a Phase III, randomised, multicentre, double-blinded study to evaluate efficacy, safety and tolerability of treatment with zibotentan/dapagliflozin and dapagliflozin alone in participants with chronic kidney disease (CKD) and high proteinuria.

Study Overview

Status

Recruiting

Conditions

Chronic Kidney Disease With High Proteinuria

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1500

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
- - Buenos Aires, Argentina, C1425AGC
    - Not yet recruiting
    - Research Site
  - Ciudad de Buenos Aires, Argentina, 1280
    - Not yet recruiting
    - Research Site
  - Mar del Plata, Argentina, 7600
    - Not yet recruiting
    - Research Site
  - Mar del Plata, Argentina, B7600
    - Not yet recruiting
    - Research Site
  - Rosario, Argentina, S2000DSV
    - Not yet recruiting
    - Research Site
  - Santa Fe, Argentina, S3000
    - Not yet recruiting
    - Research Site
Australia
- - Gosford, Australia, 2250
    - Recruiting
    - Research Site
  - Meadowbrook, Australia, 4131
    - Recruiting
    - Research Site
  - Perth, Australia, 6000
    - Recruiting
    - Research Site
  - Reservoir, Australia, 3073
    - Recruiting
    - Research Site
  - Reservoir, Australia, 3021
    - Recruiting
    - Research Site
  - Southport, Australia, 4222
    - Recruiting
    - Research Site
Austria
- - Feldkirch, Austria, 6800
    - Not yet recruiting
    - Research Site
  - Wien, Austria, 1130
    - Not yet recruiting
    - Research Site
Brazil
- - Belem, Brazil, 66073-005
    - Not yet recruiting
    - Research Site
  - Botucatu, Brazil, 18618-687
    - Not yet recruiting
    - Research Site
  - Joinville, Brazil, 89227-680
    - Not yet recruiting
    - Research Site
  - Sao Jose Do Rio Preto, Brazil, 15090-000
    - Not yet recruiting
    - Research Site
  - São Paulo, Brazil, 01228-200
    - Not yet recruiting
    - Research Site
  - São Paulo, Brazil, 04012-909
    - Not yet recruiting
    - Research Site
  - São Paulo, Brazil, 04038-031
    - Not yet recruiting
    - Research Site
Bulgaria
- - Dobrich, Bulgaria, 9300
    - Recruiting
    - Research Site
  - Pleven, Bulgaria, 5800
    - Not yet recruiting
    - Research Site
  - Plovdiv, Bulgaria, 4000
    - Not yet recruiting
    - Research Site
  - Sofia, Bulgaria, 1680
    - Recruiting
    - Research Site
  - Stara Zagora, Bulgaria, 6000
    - Not yet recruiting
    - Research Site
Canada
- Ontario
  - London, Ontario, Canada, N6A 5A5
    - Recruiting
    - Research Site
  - Waterloo, Ontario, Canada, N2T 0C1
    - Recruiting
    - Research Site
- Quebec
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - Not yet recruiting
    - Research Site
  - Montreal, Quebec, Canada, H4J 1C5
    - Recruiting
    - Research Site
China
- - Baotou, China, 014010
    - Not yet recruiting
    - Research Site
  - Beijing, China, 102218
    - Not yet recruiting
    - Research Site
  - Beijing, China, 100029
    - Not yet recruiting
    - Research Site
  - Beijing, China, 100035
    - Not yet recruiting
    - Research Site
  - Changsha, China, 410013
    - Not yet recruiting
    - Research Site
  - Chengdu, China, 610072
    - Not yet recruiting
    - Research Site
  - Chengdu, China, 610000
    - Not yet recruiting
    - Research Site
  - Chongqing, China, 400010
    - Not yet recruiting
    - Research Site
  - Deyang, China, 618000
    - Not yet recruiting
    - Research Site
  - Foshan, China, 528000
    - Not yet recruiting
    - Research Site
  - Guangzhou, China, 510515
    - Not yet recruiting
    - Research Site
  - Guangzhou, China, 510120
    - Not yet recruiting
    - Research Site
  - Hangzhou, China, 310014
    - Not yet recruiting
    - Research Site
  - Hengyang, China, 50012
    - Not yet recruiting
    - Research Site
  - Linhai, China, 318000
    - Not yet recruiting
    - Research Site
  - Nanjing, China, 210009
    - Not yet recruiting
    - Research Site
  - Nanjing, China, 210011
    - Not yet recruiting
    - Research Site
  - Nanning, China, 530022
    - Not yet recruiting
    - Research Site
  - Ningbo, China, 315010
    - Not yet recruiting
    - Research Site
  - Pingxiang, China, 337055
    - Not yet recruiting
    - Research Site
  - Shanghai, China, 200240
    - Not yet recruiting
    - Research Site
  - Shantou, China, 515041
    - Not yet recruiting
    - Research Site
  - Shenzhen, China, 518053
    - Not yet recruiting
    - Research Site
  - Shenzhen, China, 518039
    - Not yet recruiting
    - Research Site
  - Wenzhou, China, 325000
    - Not yet recruiting
    - Research Site
  - Wuhan, China, 430010
    - Not yet recruiting
    - Research Site
  - Wuxi, China, 214000
    - Not yet recruiting
    - Research Site
  - XI 'an, China, 710077
    - Not yet recruiting
    - Research Site
  - Xiamen, China, 361101
    - Not yet recruiting
    - Research Site
  - Yantai, China, 264000
    - Not yet recruiting
    - Research Site
  - Yibin, China, 610500
    - Not yet recruiting
    - Research Site
  - Yinchuan, China, 750004
    - Not yet recruiting
    - Research Site
  - Zhuzhou, China, 412007
    - Not yet recruiting
    - Research Site
  - Zigong, China, 643000
    - Not yet recruiting
    - Research Site
Denmark
- - Aalborg, Denmark, 9100
    - Recruiting
    - Research Site
  - Aarhus, Denmark, 8200
    - Not yet recruiting
    - Research Site
  - Herlev, Denmark, 2730
    - Recruiting
    - Research Site
  - Herning, Denmark, 7400
    - Recruiting
    - Research Site
  - Hvidovre, Denmark, 2650
    - Withdrawn
    - Research Site
  - Roskilde, Denmark, 4000
    - Recruiting
    - Research Site
France
- - La Tronche, France, 38700
    - Not yet recruiting
    - Research Site
  - Mulhouse, France, 68100
    - Not yet recruiting
    - Research Site
  - Nice, France, 06000
    - Not yet recruiting
    - Research Site
  - Nimes, France, 30000
    - Not yet recruiting
    - Research Site
  - Rouen, France, 76031
    - Not yet recruiting
    - Research Site
  - St-Priest-en-Jarez, France, 42270
    - Not yet recruiting
    - Research Site
  - Strasbourg, France, 67090
    - Not yet recruiting
    - Research Site
  - Tours, France, 37000
    - Recruiting
    - Research Site
Germany
- - Aachen, Germany, 52074
    - Not yet recruiting
    - Research Site
  - Bad Oeynhausen, Germany, 32545
    - Recruiting
    - Research Site
  - Berlin, Germany, 10117
    - Not yet recruiting
    - Research Site
  - Fulda, Germany, 36043
    - Withdrawn
    - Research Site
  - Geilenkirchen, Germany, 52511
    - Not yet recruiting
    - Research Site
  - Hannover, Germany, 30625
    - Not yet recruiting
    - Research Site
  - Köln, Germany, 01279
    - Not yet recruiting
    - Research Site
  - Köln, Germany, 50931
    - Suspended
    - Research Site
  - Mainz, Germany, 55131
    - Recruiting
    - Research Site
  - München, Germany, 80336
    - Not yet recruiting
    - Research Site
India
- - Belagavi, India, 590010
    - Not yet recruiting
    - Research Site
Israel
- - Ashkelon, Israel, 78278
    - Recruiting
    - Research Site
  - Haifa, Israel, 3109601
    - Recruiting
    - Research Site
  - Jerusalem, Israel, 9372212
    - Recruiting
    - Research Site
  - Kfar-Saba, Israel, 44281
    - Recruiting
    - Research Site
  - Nahariya, Israel, 22100
    - Recruiting
    - Research Site
  - Petah Tikva, Israel, 49372
    - Recruiting
    - Research Site
  - Ramat Gan, Israel, 52621
    - Recruiting
    - Research Site
  - Rehovot, Israel, 76100
    - Recruiting
    - Research Site
Italy
- - Bergamo, Italy, 24127
    - Not yet recruiting
    - Research Site
  - Bologna, Italy, 40138
    - Not yet recruiting
    - Research Site
  - Foggia, Italy, 71100
    - Not yet recruiting
    - Research Site
  - Genoa, Italy, 16132
    - Recruiting
    - Research Site
  - Napoli, Italy, 80138
    - Not yet recruiting
    - Research Site
  - Pisa, Italy, 56124
    - Not yet recruiting
    - Research Site
  - Roma, Italy, 161
    - Recruiting
    - Research Site
  - Torino, Italy, 10126
    - Not yet recruiting
    - Research Site
  - Viterbo, Italy, 01100
    - Not yet recruiting
    - Research Site
Japan
- - Chuo-ku, Japan, 103-0027
    - Recruiting
    - Research Site
  - Fujisawa-shi, Japan, 251-0041
    - Recruiting
    - Research Site
  - Fukuoka-shi, Japan, 810-8563
    - Not yet recruiting
    - Research Site
  - Fukuoka-shi, Japan, 810-0001
    - Not yet recruiting
    - Research Site
  - Fukuoka-shi, Japan, 819-0168
    - Recruiting
    - Research Site
  - Hamada-shi, Japan, 697-8511
    - Withdrawn
    - Research Site
  - Hashima-gun, Japan, 501-6061
    - Not yet recruiting
    - Research Site
  - Kamakura-shi, Japan, 247-0056
    - Recruiting
    - Research Site
  - Kasuga-shi, Japan, 816-0864
    - Recruiting
    - Research Site
  - Kawaguchi-shi, Japan, 332-0012
    - Not yet recruiting
    - Research Site
  - Kitakyushu-shi, Japan, 802-8555
    - Not yet recruiting
    - Research Site
  - Kitakyusyu-shi, Japan, 806-8501
    - Not yet recruiting
    - Research Site
  - Kofu-shi, Japan, 400-8506
    - Not yet recruiting
    - Research Site
  - Kurume-shi, Japan, 830-0011
    - Not yet recruiting
    - Research Site
  - Kurume-shi, Japan, 830-8543
    - Recruiting
    - Research Site
  - Kusatsu-shi, Japan, 525-8585
    - Not yet recruiting
    - Research Site
  - Kyoto-shi, Japan, 607-8062
    - Not yet recruiting
    - Research Site
  - Matsumoto-shi, Japan, 390-8510
    - Not yet recruiting
    - Research Site
  - Meguro-ku, Japan, 153-0061
    - Not yet recruiting
    - Research Site
  - Minato-ku, Japan, 108-0073
    - Recruiting
    - Research Site
  - Minokamo shi, Japan, 505-0010
    - Not yet recruiting
    - Research Site
  - Miyazaki, Japan, 889-1301
    - Withdrawn
    - Research Site
  - Nishinomiya-Shi, Japan, 662-0918
    - Not yet recruiting
    - Research Site
  - Nishinomiya-shi, Japan, 662-0971
    - Not yet recruiting
    - Research Site
  - Okawa-shi, Japan, 831-0016
    - Recruiting
    - Research Site
  - Osaka-shi, Japan, 559-0012
    - Not yet recruiting
    - Research Site
  - Osaka-shi, Japan, 550-0006
    - Not yet recruiting
    - Research Site
  - Oyama-shi, Japan, 323-0022
    - Recruiting
    - Research Site
  - Saku-shi, Japan, 385-8558
    - Not yet recruiting
    - Research Site
  - Sanuki-shi, Japan, 769-2401
    - Withdrawn
    - Research Site
  - Sapporo-shi, Japan, 062-0931
    - Not yet recruiting
    - Research Site
  - Sapporo-shi, Japan, 003-0026
    - Not yet recruiting
    - Research Site
  - Sendai-shi, Japan, 980-8574
    - Not yet recruiting
    - Research Site
  - Soka-shi, Japan, 340-0015
    - Not yet recruiting
    - Research Site
  - Takamatsu-shi, Japan, 760-0076
    - Recruiting
    - Research Site
  - Takasago-shi, Japan, 676-0812
    - Recruiting
    - Research Site
  - Tondabayashi-shi, Japan, 584-0082
    - Not yet recruiting
    - Research Site
  - Toride-shi, Japan, 302-0022
    - Not yet recruiting
    - Research Site
  - Urayasu, Japan, 279-0001
    - Not yet recruiting
    - Research Site
  - Utsunomiya-shi, Japan, 320-8580
    - Not yet recruiting
    - Research Site
Korea, Republic of
- - Ansan-si, Korea, Republic of, 15355
    - Not yet recruiting
    - Research Site
  - Busan, Korea, Republic of, 49241
    - Not yet recruiting
    - Research Site
  - Cheonan-si, Korea, Republic of, 31151
    - Not yet recruiting
    - Research Site
  - Daegu, Korea, Republic of, 41944
    - Not yet recruiting
    - Research Site
  - Goyang-si, Korea, Republic of, 10380
    - Not yet recruiting
    - Research Site
  - Seoul, Korea, Republic of, 06591
    - Not yet recruiting
    - Research Site
  - Seoul, Korea, Republic of, 120-752
    - Not yet recruiting
    - Research Site
  - Seoul, Korea, Republic of, 156-707
    - Not yet recruiting
    - Research Site
Malaysia
- - Alor Setar, Malaysia, 5460
    - Not yet recruiting
    - Research Site
  - Ipoh, Malaysia, 30990
    - Not yet recruiting
    - Research Site
  - Kota Kinabalu, Malaysia, 88200
    - Not yet recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 59100
    - Not yet recruiting
    - Research Site
  - Seremban, Malaysia, 70300
    - Not yet recruiting
    - Research Site
  - Seri Manjung, Malaysia, 32040
    - Not yet recruiting
    - Research Site
Mexico
- - Cuautitlán, Mexico, 91900
    - Withdrawn
    - Research Site
  - Cuernavaca, MOR, Mexico, 62448
    - Not yet recruiting
    - Research Site
  - Mazatlán, Mexico, 82110
    - Not yet recruiting
    - Research Site
  - Mazatlán, Mexico, 82000
    - Not yet recruiting
    - Research Site
  - Mexico, Mexico, 14080
    - Not yet recruiting
    - Research Site
  - Monterrey, Mexico, 64460
    - Not yet recruiting
    - Research Site
  - Saltillo, Mexico, 25230
    - Withdrawn
    - Research Site
  - Veracruz, Mexico, 91900
    - Not yet recruiting
    - Research Site
  - Veracruz, Mexico, 91910
    - Not yet recruiting
    - Research Site
Netherlands
- - Amersfoort, Netherlands, 3813 TZ
    - Recruiting
    - Research Site
  - Breda, Netherlands, 4818 CK
    - Not yet recruiting
    - Research Site
  - Dordrecht, Netherlands, 3318 AT
    - Not yet recruiting
    - Research Site
Norway
- - Bodø, Norway, 8073
    - Not yet recruiting
    - Research Site
  - Lørenskog, Norway, 1478
    - Not yet recruiting
    - Research Site
  - Oslo, Norway, 0450
    - Not yet recruiting
    - Research Site
  - Stavanger, Norway, 4011
    - Not yet recruiting
    - Research Site
  - Tromsø, Norway, 9019
    - Not yet recruiting
    - Research Site
Philippines
- - Angeles City, Philippines, 2009
    - Not yet recruiting
    - Research Site
  - Davao DEL SUR, Philippines, 8000
    - Not yet recruiting
    - Research Site
  - Iloilo City, Philippines, 5000
    - Not yet recruiting
    - Research Site
  - Manila, Philippines, 1000
    - Not yet recruiting
    - Research Site
  - Pasig City, Philippines, 1605
    - Not yet recruiting
    - Research Site
  - Quezon City, Philippines, 1101
    - Not yet recruiting
    - Research Site
Poland
- - Chrzanów, Poland, 32-500
    - Not yet recruiting
    - Research Site
  - Katowice, Poland, 40-611
    - Withdrawn
    - Research Site
  - Krakow, Poland, 31-501
    - Recruiting
    - Research Site
  - Kraków, Poland, 31-156
    - Not yet recruiting
    - Research Site
  - Lublin, Poland, 20-954
    - Not yet recruiting
    - Research Site
  - Poznań, Poland, 60-354
    - Not yet recruiting
    - Research Site
  - Radom, Poland, 26-600
    - Recruiting
    - Research Site
  - Rzeszów, Poland, 35-055
    - Recruiting
    - Research Site
  - Szczecin, Poland, 70-111
    - Not yet recruiting
    - Research Site
  - Warszawa, Poland, 03-291
    - Not yet recruiting
    - Research Site
  - Łódź, Poland, 92-213
    - Not yet recruiting
    - Research Site
Slovakia
- - Kosice, Slovakia, 04001
    - Not yet recruiting
    - Research Site
  - Lucenec, Slovakia, 984 01
    - Not yet recruiting
    - Research Site
  - Presov, Slovakia, 080 01
    - Recruiting
    - Research Site
  - Puchov, Slovakia, 020 01
    - Not yet recruiting
    - Research Site
  - Roznava, Slovakia, 048 01
    - Not yet recruiting
    - Research Site
  - Trebišov, Slovakia, 07501
    - Not yet recruiting
    - Research Site
South Africa
- - Benoni, South Africa, 1501
    - Not yet recruiting
    - Research Site
  - Cape Town, South Africa, 7925
    - Not yet recruiting
    - Research Site
  - Chatsworth, South Africa, 4092
    - Not yet recruiting
    - Research Site
  - Durban, South Africa, 4450
    - Not yet recruiting
    - Research Site
  - Lenasia, South Africa, 1827
    - Not yet recruiting
    - Research Site
  - Midrand, South Africa, 1685
    - Not yet recruiting
    - Research Site
  - Parow, South Africa, 7505
    - Not yet recruiting
    - Research Site
  - Soweto, South Africa, 2013
    - Withdrawn
    - Research Site
Spain
- - Girona, Spain, 17007
    - Not yet recruiting
    - Research Site
  - L'Hospitalet de Llobregat, Spain, 08907
    - Not yet recruiting
    - Research Site
  - Lugo, Spain, 27004
    - Not yet recruiting
    - Research Site
  - Madrid, Spain, 28041
    - Not yet recruiting
    - Research Site
  - Majadahonda, Spain, 28222
    - Not yet recruiting
    - Research Site
  - Sevilla, Spain, 41071
    - Not yet recruiting
    - Research Site
  - Valencia, Spain, 46010
    - Not yet recruiting
    - Research Site
Sweden
- - Göteborg, Sweden, 413 46
    - Recruiting
    - Research Site
  - Linköping, Sweden, 581 85
    - Recruiting
    - Research Site
  - Rättvik, Sweden, 79530
    - Not yet recruiting
    - Research Site
  - Stockholm, Sweden, 141 86
    - Not yet recruiting
    - Research Site
  - Uppsala, Sweden, 751 85
    - Recruiting
    - Research Site
Taiwan
- - Kaohsiung, Taiwan, 807
    - Recruiting
    - Research Site
  - Kaohsiung city, Taiwan, 833
    - Recruiting
    - Research Site
  - New Taipei, Taiwan, 220
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40705
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 10002
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 11490
    - Recruiting
    - Research Site
  - Taipei City, Taiwan, 110
    - Recruiting
    - Research Site
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Research Site
  - Yong Kang City, Taiwan, 710
    - Recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10700
    - Not yet recruiting
    - Research Site
  - Bangkok, Thailand, 10330
    - Not yet recruiting
    - Research Site
  - Chaingmai, Thailand, 50200
    - Not yet recruiting
    - Research Site
  - Hat Yai, Thailand, 90110
    - Not yet recruiting
    - Research Site
  - Khon Kaen, Thailand, 40002
    - Not yet recruiting
    - Research Site
  - Ratchathewi, Thailand, 10400
    - Not yet recruiting
    - Research Site
Turkey
- - Adapazarı, Turkey, 54100
    - Not yet recruiting
    - Research Site
  - Ankara, Turkey, 06230
    - Not yet recruiting
    - Research Site
  - Antalya, Turkey, 07100
    - Not yet recruiting
    - Research Site
  - Bursa, Turkey, 16059
    - Not yet recruiting
    - Research Site
  - Dinar, Turkey, 03400
    - Not yet recruiting
    - Research Site
  - Kahramanmaras, Turkey, 46040
    - Not yet recruiting
    - Research Site
  - Kayseri, Turkey, 38039
    - Not yet recruiting
    - Research Site
  - Kocaeli, Turkey, 41380
    - Not yet recruiting
    - Research Site
United Kingdom
- - Cardiff, United Kingdom, CF14 4XW
    - Recruiting
    - Research Site
  - Glasgow, United Kingdom, G51 4TF
    - Recruiting
    - Research Site
  - London, United Kingdom, NW3 2QG
    - Not yet recruiting
    - Research Site
  - London, United Kingdom, EC1A 2BE
    - Recruiting
    - Research Site
  - London, United Kingdom, SE5 9RJ
    - Recruiting
    - Research Site
  - York, United Kingdom, YO21 8HE
    - Recruiting
    - Research Site
United States
- Alabama
  - Huntsville, Alabama, United States, 35805
    - Recruiting
    - Research Site
  - Irondale, Alabama, United States, 35210
    - Not yet recruiting
    - Research Site
- Arizona
  - Sun City West, Arizona, United States, 85375
    - Recruiting
    - Research Site
- Arkansas
  - Little Rock, Arkansas, United States, 72202
    - Not yet recruiting
    - Research Site
- California
  - Bakersfield, California, United States, 93309
    - Recruiting
    - Research Site
  - Huntington Park, California, United States, 90255
    - Recruiting
    - Research Site
  - Northridge, California, United States, 91324
    - Recruiting
    - Research Site
  - Oxnard, California, United States, 93036
    - Not yet recruiting
    - Research Site
  - Redwood City, California, United States, 94062
    - Not yet recruiting
    - Research Site
  - San Carlos, California, United States, 94070
    - Suspended
    - Research Site
  - San Dimas, California, United States, 91773
    - Recruiting
    - Research Site
  - Tarzana, California, United States, 91356
    - Recruiting
    - Research Site
  - Victorville, California, United States, 92392
    - Recruiting
    - Research Site
- Colorado
  - Arvada, Colorado, United States, 80002
    - Not yet recruiting
    - Research Site
  - Denver, Colorado, United States, 80230
    - Not yet recruiting
    - Research Site
- Connecticut
  - Hamden, Connecticut, United States, 06517
    - Withdrawn
    - Research Site
  - Waterbury, Connecticut, United States, 06708
    - Withdrawn
    - Research Site
- Florida
  - Boynton Beach, Florida, United States, 33435
    - Recruiting
    - Research Site
  - Hialeah, Florida, United States, 33016
    - Not yet recruiting
    - Research Site
  - Hollywood, Florida, United States, 33024
    - Not yet recruiting
    - Research Site
  - Hollywood, Florida, United States, 33021
    - Not yet recruiting
    - Research Site
  - Jacksonville, Florida, United States, 32204
    - Not yet recruiting
    - Research Site
  - Jensen Beach, Florida, United States, 34957
    - Not yet recruiting
    - Research Site
  - Miami, Florida, United States, 33165
    - Recruiting
    - Research Site
  - Miami, Florida, United States, 33126
    - Not yet recruiting
    - Research Site
  - Orlando, Florida, United States, 32806
    - Not yet recruiting
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30315
    - Not yet recruiting
    - Research Site
  - Fayetteville, Georgia, United States, 30214
    - Not yet recruiting
    - Research Site
- Illinois
  - Champaign, Illinois, United States, 61822
    - Not yet recruiting
    - Research Site
  - Chicago, Illinois, United States, 60612
    - Not yet recruiting
    - Research Site
  - Chicago, Illinois, United States, 60616
    - Not yet recruiting
    - Research Site
  - Hinsdale, Illinois, United States, 60521
    - Not yet recruiting
    - Research Site
  - Island Lake, Illinois, United States, 60042
    - Not yet recruiting
    - Research Site
  - Skokie, Illinois, United States, 60077
    - Not yet recruiting
    - Research Site
- Kentucky
  - Bowling Green, Kentucky, United States, 42101
    - Not yet recruiting
    - Research Site
- Louisiana
  - Shreveport, Louisiana, United States, 71101
    - Not yet recruiting
    - Research Site
- Maryland
  - Silver Spring, Maryland, United States, 20901
    - Not yet recruiting
    - Research Site
- Michigan
  - Flint, Michigan, United States, 48504
    - Recruiting
    - Research Site
  - Flint, Michigan, United States, 48532
    - Recruiting
    - Research Site
  - Pontiac, Michigan, United States, 48341
    - Not yet recruiting
    - Research Site
  - Troy, Michigan, United States, 48098
    - Not yet recruiting
    - Research Site
- Missouri
  - Saint Peters, Missouri, United States, 63376
    - Not yet recruiting
    - Research Site
- New York
  - Albany, New York, United States, 12205
    - Recruiting
    - Research Site
  - Orchard Park, New York, United States, 14127
    - Not yet recruiting
    - Research Site
  - Smithtown, New York, United States, 11787
    - Not yet recruiting
    - Research Site
- North Carolina
  - Greenville, North Carolina, United States, 27834
    - Recruiting
    - Research Site
  - Jacksonville, North Carolina, United States, 28546
    - Recruiting
    - Research Site
  - Kinston, North Carolina, United States, 28504
    - Recruiting
    - Research Site
  - New Bern, North Carolina, United States, 28562
    - Recruiting
    - Research Site
  - Wilmington, North Carolina, United States, 28401
    - Recruiting
    - Research Site
  - Winston-Salem, North Carolina, United States, 27103
    - Recruiting
    - Research Site
- Ohio
  - Maumee, Ohio, United States, 43537
    - Recruiting
    - Research Site
- Pennsylvania
  - Pottstown, Pennsylvania, United States, 19465
    - Not yet recruiting
    - Research Site
- Tennessee
  - Bartlett, Tennessee, United States, 38133
    - Not yet recruiting
    - Research Site
  - Kingsport, Tennessee, United States, 37660
    - Recruiting
    - Research Site
- Texas
  - Arlington, Texas, United States, 76015
    - Recruiting
    - Research Site
  - Austin, Texas, United States, 78726
    - Not yet recruiting
    - Research Site
  - Fort Worth, Texas, United States, 76132
    - Not yet recruiting
    - Research Site
  - Houston, Texas, United States, 77004
    - Recruiting
    - Research Site
  - Houston, Texas, United States, 77099
    - Recruiting
    - Research Site
  - Missouri City, Texas, United States, 77459
    - Not yet recruiting
    - Research Site
  - Pearland, Texas, United States, 77584
    - Recruiting
    - Research Site
  - San Antonio, Texas, United States, 78212
    - Recruiting
    - Research Site
  - San Antonio, Texas, United States, 78207
    - Not yet recruiting
    - Research Site
  - San Antonio, Texas, United States, 78204
    - Recruiting
    - Research Site
- Utah
  - Salt Lake City, Utah, United States, 84115
    - Not yet recruiting
    - Research Site
- Virginia
  - Newport News, Virginia, United States, 23606
    - Recruiting
    - Research Site
- Washington
  - Spokane, Washington, United States, 99202
    - Not yet recruiting
    - Research Site
Vietnam
- - Ha Noi, Vietnam, 100000
    - Not yet recruiting
    - Research Site
  - Hai Phong, Vietnam, 180000
    - Not yet recruiting
    - Research Site
  - Ho Chi Minh, Vietnam, 700000
    - Not yet recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 70000
    - Not yet recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam
    - 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:

Participant must be ≥ 18 years of age and of legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.
Diagnosis of CKD, defined as eGFR ≥ 20 and < 90 mL/min/1.73 m2 and UACR > 700 mg/g (> 79 mg/mmol) or UPCR > 1000 mg/g (> 113 mg/mmoL).
All female participants must have a negative serum pregnancy test result at screening.
Female participants must be either
- not of child-bearing potential or
- women of child bearing potential (WOCBP) using at least one highly effective birth control method for at least 3 months prior to first dose of study intervention
Capable of giving signed informed consent
Provision of signed informed consent prior to any study specific procedure.
Provision of electronic informed consent prior to completion of the optional Study Participant Feedback Questionnaire (SPFQ).
Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form prior to collection of samples for optional genomics imitative research that supports the Genomic Initiative.
Receiving RAASi therapy (ACEi or ARB), and for the patient maximum tolerated labelled daily dose, that has been stable for at least 4 weeks.

Exclusion Criteria:

Participants with NYHA class III or class IV Congestive HF at the time of enrolment.
Participants hospitalised for HF during the last 6 month prior to screening.
Evidence of rales or jugular venous distention on physical examination.
Participants with type 1 diabetes mellitus.
History of any life-threatening ventricular dysrhythmia (continuous or paroxysmal).
Blood pressure above 160 mmHg systolic.
Blood pressure below 90 mmHg systolic.
Participants hospitalised for heart disease or cardiac procedures or for COVID-19 during the last 3 months prior to screening.
History of solid organ transplantation or bone marrow transplant.
History or ongoing allergy/hypersensitivity, as judged by the Investigator, to SGLT2i therapy (eg, dapagliflozin, canagliflozin, empagliflozin or other SGLT2 inhibitors) or Endothelin Receptor Antagonists (eg, ambrisentan, atrasentan, bosentan, or other).
Any condition with a life expectancy of less than 2 years based on investigator´s clinical judgment.
Malignancy within the past 5 years. Exceptions to this criterion include non-melanoma skin cancer and curatively treated cervical carcinoma in situ.
Significant liver disease as judged by the investigator or severe hepatic impairment with AST or ALT > 3 × ULN; or total bilirubin > 2 × ULN at time of screening. An isolated increase in bilirubin in participants with known Gilbert's syndrome is not a reason for exclusion.
Known blood-borne diseases.
Clinically significant, unstable, or uncontrolled medical condition as assessed by the Investigator.
Participants on renal replacement therapy or previous kidney transplant.
Known history of drug or alcohol abuse within 12 months of screening.
Participants on treatment with strong or moderate CYP3A4 inducer.
Participants on systemic immunosuppression therapy other than stable maintenance therapy defined as prednisone 10 mg/day (or equivalent) or less, aziothioprine 100 mg/day or less; MMF 1000 mg/day or less for at least 3 months prior to Visit 1. Inhaled, nasal or dermatological steroids are also allowed.
Participants treated or expecting to be treated with tolvaptan, any other ERAs, or budesonide (where used to treat IBD or IgAN).
Participation in another clinical study with a study intervention administered in the last 3 months.

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: Zibotentan/Dapagliflozin dose A or Zibotentan/Dapagliflozin dose B Drug dose (dose A or B) are determined based on eGFR values. Participants will receive daily oral dose of zibotentan/dapagliflozin in fixed dose combination.	Drug: Zibotentan/Dapagliflozin Participants will receive zibotentan/dapagliflozin in fixed-dose combination as per the arms they are randomized to
Active Comparator: Dapagliflozin alone Participants will receive daily oral dose of dapagliflozin.	Drug: Dapagliflozin Participants will receive dapagliflozin as per the arms they are randomized to

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in eGFR from baseline Time Frame: At month 24	To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone to slow decline in kidney function	At month 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Urine Protein to Creatinine Ratio (UPCR) from baseline to each participant's mean level Time Frame: Across the visits from Day 15 up to Month 24	To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone in reducing proteinuria	Across the visits from Day 15 up to Month 24
Change in UACR from baseline to each participant's mean level Time Frame: Across the visits from Day 15 up to Month 24	To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone in reducing albuminuria	Across the visits from Day 15 up to Month 24
Time to the first occurrence of any of the components of the renal composite endpoint of 40% sustained decline in eGFR or ESKD or renal death Time Frame: Through study completion, approximately 43 months	To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone in reducing the incidence of the renal composite endpoint of 40% sustained decline in eGFR or ESKD or renal death	Through study completion, approximately 43 months
Change in systolic blood pressure from baseline to each participant's mean level Time Frame: Across the visits from Day 15 up to Month 24	To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone in reducing systolic blood pressure	Across the visits from Day 15 up to Month 24
Proportion of participants achieving Urine Protein to Creatinine Ratio (UPCR) < 1000 mg/g and > 30% reduction from baseline for each participant's mean level Time Frame: Across the visits from Day 15 up to Month 24	To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone, in reducing proteinuria, as measured by the proportion of participants achieving Urine Protein to Creatinine Ratio (UPCR) < 1000 mg/g and > 30% reduction from baseline	Across the visits from Day 15 up to Month 24

Collaborators and Investigators

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

Sponsor

AstraZeneca

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)

November 7, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

October 4, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D4325C00010

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. 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 shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer 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 de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:

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

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 (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

Collaborators and Investigators

Sponsor

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 With High Proteinuria

Clinical Trials on Zibotentan/Dapagliflozin

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Sponsors and Collaborators

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Drug Interventions

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Conditions

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Dietary Supplements

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