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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
Sponsor: AstraZeneca
Summary
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
5000
Start Date
2025-03-03
Completion Date
2029-12-18
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Baxdrostat/dapagliflozin
baxdrostat tablet dapagliflozin tablet
Placebo/dapagliflozin
dapagliflozin tablet placebo tablet
Locations (756)
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Fairhope, Alabama, United States
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Surprise, Arizona, United States
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Tucson, Arizona, United States
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Durban, South Africa
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Durban, South Africa
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Extension 8, Lenasia, South Africa
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KwaDukuza, South Africa
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Lenasia, South Africa
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Midrand, South Africa
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Newton, South Africa
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Parow, South Africa
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Ansan-si, South Korea
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Anyang-si, South Korea
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Busan, South Korea
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Cheonan-si, South Korea
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Goyang-si, South Korea
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Gwangju, South Korea
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Seongnam-si, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Wŏnju, South Korea
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Yangsan, South Korea
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A Coruña, Spain
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Almería, Spain
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Badalona, Spain
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L'Hospitalet de Llobregat, Spain
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Majadahonda, Spain
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Málaga, Spain
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Palma deMallorca, Spain
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Pamplona, Spain
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Seville, Spain
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Seville, Spain
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Valencia, Spain
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Valencia, Spain
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Huddinge, Sweden
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Karlstad, Sweden
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Linköping, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Vaxjo, Sweden
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New Taipei City, Taiwan
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Taichung, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Yung Kang City, Taiwan
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Bangkok, Thailand
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Bangkok, Thailand
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Bangkok, Thailand
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Banphaeo, Thailand
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Hat Yai, Thailand
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Khon Kaen, Thailand
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Mueang, Thailand
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Phutthamonthon, Thailand
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Ubonratchathani, Thailand
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Adana, Turkey (Türkiye)
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Adapazarı, Turkey (Türkiye)
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Altındağ, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Antalya, Turkey (Türkiye)
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Haliliye, Turkey (Türkiye)
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Kahramanmaraş, Turkey (Türkiye)
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Kayseri, Turkey (Türkiye)
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Kocaeli, Turkey (Türkiye)
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Şahinbey, Turkey (Türkiye)
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Chernivtsі, Ukraine
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Ivano-Frankivsk, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Kyiv, Ukraine
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Ternopil, Ukraine
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Ternopil, Ukraine
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Uzhhorod, Ukraine
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Uzhhorod, Ukraine
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Vinnytsia, Ukraine
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Vinnytsia, Ukraine
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Vinnytsia, Ukraine
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Zhytomyr, Ukraine
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Bradford, United Kingdom
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Bristol, United Kingdom
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Canterbury, United Kingdom
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Cardiff, United Kingdom
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Dundee, United Kingdom
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Glasgow, United Kingdom
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Hounslow, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Salford, United Kingdom
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Southampton, United Kingdom
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Swansea, United Kingdom
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Da Nang, Vietnam
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Haiphong, Vietnam
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam
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Rach Gia, Vietnam