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.
Start Date
12/5/2025
Completion Date
5/24/2027
Summary
International, Multicenter and Double-Blind study. The purpose is to measure the effect of baxdrostat in combination with dapagliflozin compared with baxdrostat/placebo on albuminuria, as well as safety, in participants with chronic kidney disease and high blood pressure.
Detailed Description
This is a Phase IIb, randomised, multicentre, double-blind, parallel-group study aiming to determine the effect on albuminuria, as well as safety, of baxdrostat/dapagliflozin compared with baxdrostat/placebo, when given to participants with CKD and high blood pressure. Study population will include participants ≥ 18 years old with CKD. Participants with or without a diagnosis of T2DM and with or without an SGLT2i treatment at screening are eligible for the study. The study will include an optional pre-screening period, where participants will be assessed for at least one of the following parameters: eGFR, UACR, potassium, sodium, and BP. Participants who are being treated with SGLT2i at the time of the screening visit will complete a washout period After screening and initial confirmation of eligibility, participants will be randomised to receive either baxdrostat/dapagliflozin or baxdrostat/placebo. For randomisation there will be stratification and capping linked to T2DM status. The primary objective is to assess the effect of baxdrostat/dapagliflozin compared with baxdrostat/matching placebo on albuminuria, which will be evaluated by change from baseline in UACR. The end of the study is defined as the date of the last visit of the last participant in the study or last scheduled procedure shown in the SoA for the last participant in the study globally, whichever occurs last. A participant is considered to have completed the study if they have completed all periods of the study including the last scheduled procedure shown in the SoA.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Baxdrostat/dapagliflozin
Baxdrostat/Placebo
Conditions
Locations
Research Site
Surprise, Arizona 85374
United States
Research Site
Hollywood, Florida 33021
United States
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Port Charlotte, Florida 33952
United States
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Port Orange, Florida 32127
United States
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Atlanta, Georgia 30344
United States
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Champaign, Illinois 61822
United States
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Wichita, Kansas 67214
United States
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Eatontown, New Jersey 07724
United States
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Greenville, North Carolina 27834
United States
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Jacksonville, North Carolina 28546
United States
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New Bern, North Carolina 28562
United States
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Columbus, Ohio 43215
United States
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Media, Pennsylvania 19063
United States
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East Providence, Rhode Island 02914
United States
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Arlington, Texas 76015
United States
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Pasadena, Texas 77504
United States
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San Antonio, Texas 78212
United States
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Woodbridge, Virginia 22192
United States
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Buenos Aires, C1060AAB
Argentina
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Ciudad de Buenos Aires, C1425AGC
Argentina
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Mar del Plata, 7600
Argentina
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Rosario, S2000CVD
Argentina
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San Nicolás, B2900DMH
Argentina
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Pernik, 2300
Bulgaria
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Plovdiv, 4004
Bulgaria
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Sofia, 1431
Bulgaria
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Sofia, 1680
Bulgaria
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Sofia, 1756
Bulgaria
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Sofia, 1756
Bulgaria
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Yambol, 8600
Bulgaria
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Courtice, Ontario L1E 2J5
Canada
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Etobicoke, Ontario M9W 6V1
Canada
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Stouffville, Ontario L4A1H2
Canada
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Waterloo, Ontario N2T 0C1
Canada
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Montreal, Quebec H4J 1C5
Canada
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Anyang-si, 14068
South Korea
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Cheonan-si, 31151
South Korea
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Goyang-si, 10380
South Korea
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Seoul, 04401
South Korea
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Badalona, 08916
Spain
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Pamplona, 31008
Spain
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Valencia, 46010
Spain
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Kaohsiung City, 80756
Taiwan
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Kaohsiung City, 83301
Taiwan
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New Taipei City, 235
Taiwan
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Taichung, 402
Taiwan
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Taichung, 433004
Taiwan
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Taipei, 10002
Taiwan
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Taipei, 110
Taiwan
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Taoyuan, 333
Taiwan
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Bangkoknoi, 10700
Thailand
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Changwat Sara Buri, 18000
Thailand
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Hat Yai, 90110
Thailand
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Muang, 50200
Thailand
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Ratchathewi, 10400
Thailand
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Adana, 01060
Turkey (Türkiye)
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Adapazarı, 54290
Turkey (Türkiye)
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Kahramanmaraş, 46040
Turkey (Türkiye)
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Kayseri, 38039
Turkey (Türkiye)
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Kocaeli, 41380
Turkey (Türkiye)
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Kyiv, 01601
Ukraine
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Kyiv, 02002
Ukraine
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Kyiv, 02091
Ukraine
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Kyiv, 03037
Ukraine
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Kyiv, 03049
Ukraine
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Kyiv, 04210
Ukraine
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Uzhhorod, 88018
Ukraine
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Vinnytsia, 21029
Ukraine
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Dundee, DD1 9SY
United Kingdom
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Liverpool, L9 7AL
United Kingdom
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London, E1 1FR
United Kingdom