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.
Launched by ASTRAZENECA · Feb 13, 2024
Trial Information
Current as of September 11, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a combination of two medications, baxdrostat and dapagliflozin, to see how effective and safe they are for people with chronic kidney disease (CKD) and high blood pressure (hypertension). The trial is open to adults aged 18 and older who have specific health conditions, including a certain level of kidney function and urine protein levels. Participants will be carefully monitored over a period of 24 months, first receiving either the combination medication or dapagliflozin alone, followed by a 6-week period where everyone will take dapagliflozin only.
Eligible participants should have a stable dose of certain blood pressure medications and meet specific criteria regarding their kidney function and blood pressure levels. Throughout the study, participants will have regular check-ups to track their health and how the medications affect their kidneys. If someone needs to stop taking the trial medication early, they will still be able to continue receiving dapagliflozin. Overall, this trial aims to find better treatment options for people dealing with CKD and hypertension while ensuring their safety and health are prioritized.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Participants of any sex and gender must be ≥ 18 years old, or older, at the time of signing the informed consent.
- • 2. Participants with CKD and eGFR ≥ 30 and \< 90 mL/min/1.73 m2 at screening
- • 3. Urine albumin creatinine ratio \> 200 mg/g (22.6 mg/mmol) and \< 5000 mg/g (565 mg/mmol) at screening
- • 4. Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit
- • 5. Stable and maximum tolerated dose of an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to Screening Visit
- 6. 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:
- • 1. Systolic blood pressure \> 180 mmHg, or DBP \> 110 mmHg at screening.
- • 2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.
- • 3. Serum sodium \< 135 mmol/L at the Screening Visit, determined as per central laboratory.
- 4. 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).
- • 5. New York Heart Association functional HF class IV at screening.
- • 6. 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.
- • 7. Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
- • 8. Any acute kidney injury within 3 months prior to the Screening Visit
- • 9. History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).
- • 10. History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2 inhibitor (eg, empagliflozin) or ASI.
- • 11. Any clinical condition requiring systemic immunosuppression therapy other than stable maintenance therapy for at least 3 months prior to Visit 1.
- • 12. 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.
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Denver, Colorado, United States
Ciudad De Buenos Aires, Argentina
Montréal, Quebec, Canada
Cluj Napoca, Romania
Lublin, Poland
Fremont, California, United States
Sandanski, Bulgaria
Desio, Italy
Bochum, Germany
New Delhi, India
Napoli, Italy
Manila, Philippines
Boca Raton, Florida, United States
Boca Raton, Florida, United States
Ningbo, China
Trebic, Czechia
Bologna, Italy
Istanbul, Turkey
Hounslow, United Kingdom
San Carlos, California, United States
Fleming Island, Florida, United States
Atlanta, Georgia, United States
Austin, Texas, United States
København ø, Denmark
århus N, Denmark
Mohali, India
Seoul, Korea, Republic Of
Cluj Napoca, Romania
Leipzig, Germany
Los Alamitos, California, United States
Hazel Crest, Illinois, United States
Hutchinson, Kansas, United States
Statesville, North Carolina, United States
Kosice, Slovakia
Manassas, Virginia, United States
Veliko Tarnovo, Bulgaria
Yambol, Bulgaria
Vancouver, British Columbia, Canada
Caba, Argentina
Mendoza, Argentina
Uherske Hradiste, Czechia
Aalborg, Denmark
Esbjerg, Denmark
Falkensee, Germany
Urumqi, China
Frýdek Místek, Czechia
Jilemnice, Czechia
Hamburg, Germany
Wiesbaden, Germany
Herne, Germany
Witten, Germany
Mainz, Germany
Kecskemét, Hungary
Nyíregyháza, Hungary
Ahmedabad, India
Alexandroupolis, Greece
Ramat Gan, Israel
Chiavari, Italy
Krakow, Poland
Lodz, Poland
Lublin, Poland
Seremban, Malaysia
Warszawa, Poland
Taiping, Malaysia
Trnava, Slovakia
Hilversum, Netherlands
Durban, South Africa
Lenasia, South Africa
Varberg, Sweden
Istanbul, Turkey
Kahramanmaras, Turkey
Yung Kang City, Taiwan
Adapazarı, Turkey
Kayseri, Turkey
Kocaeli, Turkey
Newcastle Under Lyme, United Kingdom
Uzhhorod, Ukraine
Wolverhampton, United Kingdom
Phoenix, Arizona, United States
Hochiminh City, Vietnam
Torrance, California, United States
Arvada, Colorado, United States
Searcy, Arkansas, United States
Lincoln, California, United States
Champaign, Illinois, United States
Hialeah, Florida, United States
Houston, Texas, United States
Chicago, Illinois, United States
Humble, Texas, United States
Saint John, Canada
Hangzhou, China
Brussel, Belgium
Krnov, Czechia
Liège, Belgium
Nachod, Czechia
Praha 10, Czechia
Münster, Germany
Herning, Denmark
Calicut, India
Holbæk, Denmark
Chennai, India
New Delhi, India
Rehovot, Israel
Tel Aviv, Israel
Ruda śląska, Poland
Amersfoort, Netherlands
łódź, Poland
żywiec, Poland
Tilburg, Netherlands
Benoni, South Africa
Utrecht, Netherlands
Chiang Mai, Thailand
Newton, South Africa
Lake Worth, Florida, United States
Leuven, Belgium
Patras, Greece
Roeselare, Belgium
Pécs, Hungary
Bangalore, India
Lom, Bulgaria
Chuo Ku, Japan
Hat Yai, Thailand
Chernivtsі, Ukraine
Vinnytsia, Ukraine
Bristol, United Kingdom
Arequipa, Peru
Plymouth, Massachusetts, United States
Almeria, Spain
Bucuresti, Romania
Tarzana, California, United States
Saint Louis, Missouri, United States
Middletown, New York, United States
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Badalona, Spain
Salt Lake City, Utah, United States
Stara Zagora, Bulgaria
Mar Del Plata, Argentina
Dehradun, India
Hyderabad, India
Nürnberg, Germany
Rozzano, Italy
San Giovanni Rotondo, Italy
Novi Sad, Serbia
Oldenburg, Germany
Cape Town, South Africa
Lugo, Spain
Myjava, Slovakia
Madrid, Spain
Phutthamonthon, Thailand
Fullerton, California, United States
New Bern, North Carolina, United States
Gavle, Sweden
San Antonio, Texas, United States
Göteborg, Sweden
Linkoping, Sweden
Police Nad Metují, Czechia
San Nicolás, Argentina
Gent, Belgium
Ashkelon, Israel
Torino, Italy
Nitra, Slovakia
Praha 6, Czechia
Puchov, Slovakia
Herlev, Denmark
Reinfeld (Holstein), Germany
Gotse Delchev, Bulgaria
Columbus, Ohio, United States
Kozloduy, Bulgaria
Waterloo, Ontario, Canada
Quebec, Canada
Amberg, Germany
Bad Oeynhausen, Germany
Uniontown, Pennsylvania, United States
Berlin, Germany
Arlington, Texas, United States
Essen, Germany
Uijeongbu, Korea, Republic Of
Wonju Si, Korea, Republic Of
Kortrijk, Belgium
Kuantan, Malaysia
Gdynia, Poland
Kraków, Poland
Tczew, Poland
Hardenberg, Netherlands
Stanger, South Africa
Malaga, Spain
Taipei, Taiwan
Adana, Turkey
Palma Demallorca, Spain
Jacksonville, Florida, United States
Afyonkarahisar, Turkey
Cordoba, Argentina
Ieper, Belgium
Ciudad Autonoma De Bs As, Argentina
Ronse, Belgium
Ioannina, Greece
Aarhus N, Denmark
Jerusalem, Israel
Odense, Denmark
Kfar Saba, Israel
Dordrecht, Netherlands
Roosendaal, Netherlands
Iasi, Romania
Dolný Kubín, Slovakia
Banska Bystrica, Slovakia
Rožňava, Slovakia
L'hospitalet De Llobregat, Spain
Ho Chi Minh, Vietnam
Olomouc, Czechia
Heraclion, Greece
Jodhpur, India
Ankara, Turkey
Piura, Peru
Vinnytsya, Ukraine
Belgrade, Serbia
Orlando, Florida, United States
Székesfehérvár, Hungary
Bucharest, Romania
Liverpool, United Kingdom
Nis, Serbia
Bloemfontein, South Africa
Da Nang, Vietnam
Danderyd, Sweden
Taipei City, Taiwan
Valencia, Spain
Ternopil, Ukraine
Liege, Belgium
Szczecin, Poland
Wrocław, Poland
Midrand, South Africa
Milano, Italy
Parma, Italy
Rzeszów, Poland
Kaiserslautern, Germany
Uppsala, Sweden
Schwerin, Germany
Kuala Lumpur, Malaysia
La Coruna, Spain
Málaga, Spain
Bien Hoa, Vietnam
Rättvik, Sweden
Kaohsiung, Taiwan
Taichung, Taiwan
Muang, Thailand
Bursa, Turkey
Ivano Frankivsk, Ukraine
La Plata, Argentina
Praha 4, Czechia
Ratchathewi, Thailand
Sherbrooke, Quebec, Canada
Nanjing, China
Kolkata, India
Antalya, Turkey
Belagavi, India
Kaohsiung City, Taiwan
Pamplona, Spain
Honolulu, Hawaii, United States
Hollywood, Florida, United States
Kansas City, Missouri, United States
Aalst, Belgium
Detroit, Michigan, United States
Plovdiv, Bulgaria
Bonheiden, Belgium
Sliven, Bulgaria
São Paulo, Brazil
London, Ontario, Canada
Olsztyn, Poland
Alkmaar, Netherlands
Poznań, Poland
Kragujevac, Serbia
Presov, Slovakia
Zilina, Slovakia
Sevilla, Spain
Almere, Netherlands
Lima, Peru
Oshawa, Ontario, Canada
Aachen, Germany
München, Germany
Ulm, Germany
Békéscsaba, Hungary
Stockholm, Sweden
Wilmington, North Carolina, United States
Wollongong, Australia
Budapest, Hungary
Völklingen, Germany
Siófok, Hungary
Pune, India
Lucenec, Slovakia
San Francisco, California, United States
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Martin, Slovakia
Thessaloniki, Greece
Bangkok, Thailand
Mannheim, Germany
Szeged, Hungary
Glasgow, United Kingdom
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Kyiv, Ukraine
Sao Paulo, Brazil
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Tsu Shi, Japan
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Targu Mures, Romania
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Belem, Brazil
Campina Grande Do Sul, Brazil
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Shenyang, China
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Yantai, China
Yinchuan, China
Zhengzhou, China
Aarhus, Denmark
Chongqing, China
Amiens Cedex 1, France
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Copenhagen E, Denmark
Bordeaux Cedex, France
Paris, France
Poitiers, France
Quimper Cedex, France
Tours, France
Le Puy En Velay, France
Lille Cedex, France
Marseille Cedex 6, France
Marseille, France
Valenciennes, France
Montpellier, France
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Hiroshima Shi, Japan
Hiroshima, Japan
Vandoeuvre Les Nancy, France
Kofu Shi, Japan
Ina Shi, Japan
Kumagaya Shi, Japan
Shinjyuku Ku, Japan
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Urayasu, Japan
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Osaka Shi, Japan
Osaka, Japan
Riyadh, Saudi Arabia
Davao City, Philippines
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Kyiv, Ukraine
Cambridge, United Kingdom
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Coral Gables, Florida, United States
Lexington, Kentucky, United States
Bethesda, Maryland, United States
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Lewisville, Texas, United States
Santiago, Chile
Valdivia, Chile
Victoria, Chile
Odessa, Texas, United States
Nanchang, China
Panjin, China
Chuangchun, China
Wuxi, China
Harrow, United Kingdom
Takatsuki Shi, Japan
Toride Shi, Japan
Dongguan, China
Toyota Shi, Japan
Yaizu Shi, Japan
Brest Cedex, France
Lanzhou, China
Pontoise, France
Goyang Si, Korea, Republic Of
Huntley, Illinois, United States
Sakai Shi, Japan
Foshan, China
Kogarah, Australia
Baotou, China
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Sarcelles, France
Matsuyama City, Japan
Chrzanów, Poland
Parow, South Africa
Beijing, China
Fukuoka Shi, Japan
Dresden, Germany
Dunaújváros, Hungary
Nottingham, United Kingdom
Dundee, United Kingdom
Can Tho, Vietnam
London, United Kingdom
Conyers, Georgia, United States
Pleven, Bulgaria
Salt Lake City, Utah, United States
Salem, Virginia, United States
Hengyang, China
Vijayawada, India
Obihiro Shi, Japan
Ueda Shi, Japan
Daito Shi, Japan
Kamakura Shi, Japan
Buffalo, New York, United States
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Kota Kinabalu, Malaysia
Yangsan Si, Korea, Republic Of
Chorrillos, Peru
Changsha, China
Sanya, China
Laval, Quebec, Canada
Budapest, Hungary
Haifa, Israel
Montreal, Quebec, Canada
Ha Noi, Vietnam
Macon, Georgia, United States
Peachtree Corners, Georgia, United States
Manhasset, New York, United States
Nishinomiya Shi, Japan
Eatontown, New Jersey, United States
Marugame Shi, Japan
Binghamton, New York, United States
Rockville Centre, New York, United States
Xian, China
Berlin, Germany
Athens, Greece
Madurai, India
Sapporo, Japan
Parkville, Australia
Perth, Australia
Fujisawa Shi, Japan
Winnipeg, Manitoba, Canada
Fort Lauderdale, Florida, United States
Surprise, Arizona, United States
Fort Wayne, Indiana, United States
New Bedford, Massachusetts, United States
Memphis, Tennessee, United States
Burlington, Vermont, United States
Cebu City, Philippines
Quezon City, Philippines
Port Orange, Florida, United States
Evansville, Indiana, United States
Guiyang, China
Lake City, Florida, United States
Tucson, Arizona, United States
Hengyang, China
Riverview, Florida, United States
New Taipei, Taiwan
Taoyuan City, Taiwan
Charleston, South Carolina, United States
Gosford, Australia
Chattanooga, Tennessee, United States
Dupnitsa, Bulgaria
Fairfax, Virginia, United States
Surrey, British Columbia, Canada
Changzhou, China
San Fernando, Philippines
Dammam, Saudi Arabia
Huntington Park, California, United States
Saint Louis, Missouri, United States
Edgewater, Florida, United States
Melbourne, Florida, United States
Lufkin, Texas, United States
Woodbridge, Virginia, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Rockford, Illinois, United States
Zhengzhou, China
Edmonton, Alberta, Canada
Bois Guillaume, France
Boulogne Billancourt Cedex, France
Clermont Ferrand, France
Viña Del Mar, Chile
Guangzhou, China
Haikou, China
La Roche Sur Yon, France
Kawaguchi, Japan
Marseille Cedex 5, France
Kurume Shi, Japan
Kyoto Shi, Japan
Naka, Japan
Seoul, Korea, Republic Of
Klang, Malaysia
Košice, Slovakia
Toulouse, France
Gävle, Sweden
Muang, Thailand
Ubonratchathani, Thailand
Chester, Pennsylvania, United States
Lanham, Maryland, United States
Hai Phong, Vietnam
Austin, Texas, United States
Taichung City, Taiwan
Xiamen, China
Curitiba, Brazil
Can Tho, Vietnam
Boston, Massachusetts, United States
Sao Jose Do Rio Preto, Brazil
Toronto, Ontario, Canada
New York, New York, United States
Kingsport, Tennessee, United States
Houston, Texas, United States
Leicester, United Kingdom
Caba, Argentina
Darlinghurst, Australia
Changchun, China
Lille, France
Denver, Colorado, United States
Lanus, Argentina
Daejeon, Korea, Republic Of
Gwangju, Korea, Republic Of
Seoul, Korea, Republic Of
Oradea, Romania
Timisoara, Romania
Vancouver, British Columbia, Canada
Stoney Creek, Ontario, Canada
Montréal, Quebec, Canada
Kyiv, Ukraine
Pasadena, Texas, United States
Pingxiang, China
Petah Tikva, Israel
Marseille, France
Anyang Si, Korea, Republic Of
Busan, Korea, Republic Of
Cheonan Si, Korea, Republic Of
Hilversum, Netherlands
Olsztyn, Poland
São José Do Rio Preto, Brazil
Quimper, France
Vandoeuvre Les Nancy, France
Kaohsiung, Taiwan
Praha, Czechia
Bordeaux, France
Clermont Ferrand, France
A Coruña, Spain
Taoyuan, Taiwan
Ansan Si, Korea, Republic Of
L' Hospitalet De Llobregat, Spain
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported