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 June 27, 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
Houston, Texas, United States
Montpellier, , France
Arvada, Colorado, United States
Orlando, Florida, United States
Istanbul, , Turkey
Port Charlotte, Florida, United States
Pasadena, Texas, United States
Detroit, Michigan, United States
Gent, , Belgium
Liège, , Belgium
Nyíregyháza, , Hungary
Székesfehérvár, , Hungary
Nitra, , Slovakia
Madrid, , Spain
Malaga, , Spain
Evansville, Indiana, United States
Ocoee, Florida, United States
New York, New York, United States
Fullerton, California, United States
Los Alamitos, California, United States
Leuven, , Belgium
Roeselare, , Belgium
Quebec, , Canada
Napoli, , Italy
Wolverhampton, , United Kingdom
Denver, Colorado, United States
Liege, , Belgium
Plovdiv, , Bulgaria
Veliko Tarnovo, , Bulgaria
Dundee, , United Kingdom
Paris, , France
Torino, , Italy
Parkville, , Australia
Esbjerg, , Denmark
Lille, , France
Marseille, , France
Athens, , Greece
Budapest, , Hungary
Lublin, , Poland
Málaga, , Spain
Stockholm, , Sweden
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Rehovot, , Israel
Buffalo, New York, United States
Oshawa, Ontario, Canada
Denver, Colorado, United States
Melbourne, Florida, United States
Rockford, Illinois, United States
Wichita, Kansas, United States
Columbia, Missouri, United States
Kansas City, Missouri, United States
Saint Louis, Missouri, United States
New Bern, North Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
Richmond, Virginia, United States
Aalst, , Belgium
Bonheiden, , Belgium
Pleven, , Bulgaria
London, Ontario, Canada
Sherbrooke, Quebec, Canada
Santiago, , Chile
Herlev, , Denmark
Odense, , Denmark
Lille Cedex, , France
Vandoeuvre Les Nancy, , France
Mainz, , Germany
Witten, , Germany
Haifa, , Israel
Alkmaar, , Netherlands
Harderwijk, , Netherlands
Hilversum, , Netherlands
Targu Mures, , Romania
Lucenec, , Slovakia
Presov, , Slovakia
Uppsala, , Sweden
Glasgow, , United Kingdom
Rockville Centre, New York, United States
Denver, Colorado, United States
Chattanooga, Tennessee, United States
East Providence, Rhode Island, United States
Boynton Beach, Florida, United States
Atlanta, Georgia, United States
Stanford, California, United States
New York, New York, United States
Boston, Massachusetts, United States
Binghamton, New York, United States
Langhorne, Pennsylvania, United States
Kortrijk, , Belgium
Vandoeuvre Les Nancy, , France
Banska Bystrica, , Slovakia
Utrecht, , Netherlands
Lexington, Kentucky, United States
Manhasset, New York, United States
Quimper Cedex, , France
Berlin, , Germany
Kaiserslautern, , Germany
München, , Germany
Ulm, , Germany
Ioannina, , Greece
Patras, , Greece
Thessaloniki, , Greece
Badalona, , Spain
Leicester, , United Kingdom
Nottingham, , United Kingdom
San Carlos, California, United States
Coral Gables, Florida, United States
New Port Richey, Florida, United States
Wilmington, North Carolina, United States
Kingsport, Tennessee, United States
Beverly Hills, California, United States
Lake Worth, Florida, United States
Ramat Gan, , Israel
Tel Aviv, , Israel
Szczecin, , Poland
Laval, Quebec, Canada
Miami Lakes, Florida, United States
Greenville, North Carolina, United States
Ahmedabad, , India
Montreal, Quebec, Canada
Halifax, Nova Scotia, Canada
Manila, , Philippines
Chiang Mai, , Thailand
Kecskemét, , Hungary
Valencia, , Spain
Providence, Rhode Island, United States
Perth, , Australia
Hialeah, Florida, United States
Bordeaux Cedex, , France
Milano, , Italy
Hollywood, Florida, United States
Newport News, Virginia, United States
New Delhi, , India
Ashkelon, , Israel
Belgrade, , Serbia
Kragujevac, , Serbia
Nis, , Serbia
Novi Sad, , Serbia
Martin, , Slovakia
Durban, , South Africa
Salem, Virginia, United States
Budapest, , Hungary
Fort Lauderdale, Florida, United States
Hutchinson, Kansas, United States
Saint Louis, Missouri, United States
Charleston, South Carolina, United States
Ieper, , Belgium
Beijing, , China
Cebu City, , Philippines
Bloemfontein, , South Africa
Kaohsiung, , Taiwan
Stara Zagora, , Bulgaria
Clermont Ferrand, , France
Rozzano, , Italy
Fairfax, Virginia, United States
Bologna, , Italy
Aachen, , Germany
Bucharest, , Romania
Iasi, , Romania
Praha 6, , Czechia
Kyiv, , Ukraine
Zhengzhou, , China
Tucson, Arizona, United States
Vancouver, British Columbia, Canada
Jacksonville, Florida, United States
Fort Wayne, Indiana, United States
San Antonio, Texas, United States
Phoenix, Arizona, United States
Winter Haven, Florida, United States
Macon, Georgia, United States
Roseburg, Oregon, United States
Sioux Falls, South Dakota, United States
Hiroshima Shi, , Japan
Osaka Shi, , Japan
Sakai Shi, , Japan
Iloilo City, , Philippines
Taipei, , Taiwan
Bangkok, , Thailand
Ubonratchathani, , Thailand
Torrance, California, United States
Sydney, Nova Scotia, Canada
Herning, , Denmark
Dordrecht, , Netherlands
Statesville, North Carolina, United States
Clayton, , Australia
Ronse, , Belgium
Sliven, , Bulgaria
Xian, , China
Yinchuan, , China
Bad Oeynhausen, , Germany
Essen, , Germany
Münster, , Germany
Pécs, , Hungary
Busan, , Korea, Republic Of
Taiping, , Malaysia
Amersfoort, , Netherlands
Hardenberg, , Netherlands
Lublin, , Poland
Cluj Napoca, , Romania
Zilina, , Slovakia
Lenasia, , South Africa
Palma Demallorca, , Spain
Ivano Frankivsk, , Ukraine
København ø, , Denmark
Aalborg, , Denmark
Mannheim, , Germany
Poitiers, , France
Sandanski, , Bulgaria
Amiens Cedex 1, , France
Marseille Cedex 5, , France
Praha 4, , Czechia
Edmonton, Alberta, Canada
Roosendaal, , Netherlands
Oradea, , Romania
Marseille, , France
L'hospitalet De Llobregat, , Spain
Pamplona, , Spain
Tarzana, California, United States
Chengdu, , China
Parma, , Italy
Sendai Shi, , Japan
Nimes, , France
Uherske Hradiste, , Czechia
Bochum, , Germany
Cape Town, , South Africa
Lima, , Peru
Istanbul, , Turkey
New Bedford, Massachusetts, United States
Columbus, Ohio, United States
Manassas, Virginia, United States
Port Orange, Florida, United States
Plymouth, Massachusetts, United States
Pontiac, Michigan, United States
Saint Peters, Missouri, United States
Eatontown, New Jersey, United States
Orchard Park, New York, United States
Arlington, Texas, United States
Austin, Texas, United States
Lufkin, Texas, United States
Gwangju, , Korea, Republic Of
Fremont, California, United States
Huntington Park, California, United States
Honolulu, Hawaii, United States
New Hyde Park, New York, United States
Odessa, Texas, United States
Cordoba, , Argentina
Mar Del Plata, , Argentina
San Nicolás, , Argentina
Darlinghurst, , Australia
Wollongong, , Australia
Dupnitsa, , Bulgaria
Gotse Delchev, , Bulgaria
Kozloduy, , Bulgaria
Yambol, , Bulgaria
Brampton, Ontario, Canada
Concord, Ontario, Canada
Toronto, Ontario, Canada
Guangzhou, , China
Daito Shi, , Japan
Yokohama Shi, , Japan
Chrzanów, , Poland
Ruda śląska, , Poland
Dolný Kubín, , Slovakia
Košice, , Slovakia
Rättvik, , Sweden
Muang, , Thailand
Ratchathewi, , Thailand
Kyiv, , Ukraine
Changsha, , China
Wuxi, , China
San Giovanni Rotondo, , Italy
Tsu Shi, , Japan
Gdynia, , Poland
Bursa, , Turkey
Ho Chi Minh, , Vietnam
Harrow, , United Kingdom
Fleming Island, Florida, United States
Hazel Crest, Illinois, United States
Uniontown, Pennsylvania, United States
Aarhus N, , Denmark
Daejeon, , Korea, Republic Of
Olsztyn, , Poland
Cluj Napoca, , Romania
Kocaeli, , Turkey
Liverpool, , United Kingdom
Amberg, , Germany
Kogarah, , Australia
Takatsuki Shi, , Japan
Poznań, , Poland
Gosford, , Australia
Linkoping, , Sweden
Chuangchun, , China
Nanjing, , China
Shenzhen, , China
Xiamen, , China
Wiesbaden, , Germany
Ankara, , Turkey
Seoul, , Korea, Republic Of
Kamakura Shi, , Japan
Kyoto Shi, , Japan
Oita Shi, , Japan
Lincoln, California, United States
Miami, Florida, United States
Maumee, Ohio, United States
Fairhope, Alabama, United States
Curitiba, , Brazil
São Paulo, , Brazil
Lom, , Bulgaria
Waterloo, Ontario, Canada
Pingxiang, , China
Trebic, , Czechia
Schwerin, , Germany
Kurume Shi, , Japan
Toyota Shi, , Japan
Wonju Si, , Korea, Republic Of
Davao City, , Philippines
Rzeszów, , Poland
Dammam, , Saudi Arabia
Riyadh, , Saudi Arabia
Stanger, , South Africa
Hat Yai, , Thailand
Antalya, , Turkey
Warszawa, , Poland
Kayseri, , Turkey
Catanzaro, , Italy
Fujisawa Shi, , Japan
Boca Raton, Florida, United States
århus N, , Denmark
Békéscsaba, , Hungary
Seoul, , Korea, Republic Of
Tilburg, , Netherlands
Dresden, , Germany
Taipei City, , Taiwan
Kasugai Shi, , Japan
Ueda Shi, , Japan
Newcastle Under Lyme, , United Kingdom
Haikou, , China
Shanghai, , China
Seoul, , Korea, Republic Of
Hai Phong, , Vietnam
Edgewater, Florida, United States
Porto Alegre, , Brazil
Jerusalem, , Israel
Can Tho, , Vietnam
Krnov, , Czechia
Ha Noi, , Vietnam
San Francisco, California, United States
Salt Lake City, Utah, United States
Winnipeg, Manitoba, Canada
Siófok, , Hungary
Vijayawada, , India
Ansan Si, , Korea, Republic Of
Goyang Si, , Korea, Republic Of
Tczew, , Poland
Bucuresti, , Romania
New Taipei, , Taiwan
Taichung, , Taiwan
Lanham, Maryland, United States
St Leonards, , Australia
Sarcelles, , France
La Roche Sur Yon, , France
Szeged, , Hungary
Memphis, Tennessee, United States
San Fernando, , Philippines
Tours, , France
Berlin, , Germany
Oldenburg, , Germany
Ternopil, , Ukraine
Kosice, , Slovakia
Parow, , South Africa
Aarhus, , Denmark
Anyang Si, , Korea, Republic Of
Lugo, , Spain
Kfar Saba, , Israel
Vancouver, British Columbia, Canada
Falkensee, , Germany
Alexandroupolis, , Greece
Saint Joseph, Michigan, United States
Chicago, Illinois, United States
Praha 10, , Czechia
Sao Paulo, , Brazil
Hamburg, , Germany
Chuo Ku, , Japan
Guiyang, , China
Lanzhou, , China
Puchov, , Slovakia
Urumqi, , China
Yantai, , China
Almere, , Netherlands
Hangzhou, , China
Nagoya Shi, , Japan
Brussel, , Belgium
Arequipa, , Peru
Ningbo, , China
Benoni, , South Africa
Madurai, , India
Olomouc, , Czechia
Lewisville, Texas, United States
Nürnberg, , Germany
Austin, Texas, United States
Uzhhorod, , Ukraine
Ina Shi, , Japan
Shizuoka Shi, , Japan
Toride Shi, , Japan
Valdivia, , Chile
Valenciennes, , France
Vinnytsya, , Ukraine
Saint John, , Canada
Humble, Texas, United States
Wuhan, , China
Hengyang, , China
Quezon City, , Philippines
Campinas, , Brazil
Baotou, , China
Belagavi, , India
Kolkata, , India
Fukuoka Shi, , Japan
Buenos Aires, , Argentina
Joinville, , Brazil
Changchun, , China
Foshan, , China
Tsu Shi, , Japan
Yaizu Shi, , Japan
Chorrillos, , Peru
Bien Hoa, , Vietnam
Trnava, , Slovakia
Lake City, Florida, United States
Surprise, Arizona, United States
Canyon Country, California, United States
Zhengzhou, , China
La Coruna, , Spain
Klang, , Malaysia
Kuala Lumpur, , Malaysia
Seremban, , Malaysia
Lodz, , Poland
Dehradun, , India
New Delhi, , India
Dongguan, , China
Vinnytsia, , Ukraine
Nachod, , Czechia
Kraków, , Poland
Adana, , Turkey
Viña Del Mar, , Chile
Herne, , Germany
Boulogne Billancourt Cedex, , France
Stoney Creek, Ontario, Canada
Changzhou, , China
Cheonan Si, , Korea, Republic Of
Kaohsiung City, , Taiwan
Göteborg, , Sweden
Sao Jose Do Rio Preto, , Brazil
Nishinomiya Shi, , Japan
Birtinya, , Australia
Yangsan Si, , Korea, Republic Of
Bethesda, Maryland, United States
Mohali, , India
Coimbatore, , India
Belem, , Brazil
Hiroshima, , Japan
Osaka, , Japan
Obihiro Shi, , Japan
Shinjyuku Ku, , Japan
Krakow, , Poland
Pontoise, , France
Huai'an, , China
Varberg, , Sweden
Bristol, , United Kingdom
łódź, , Poland
Atlanta, Georgia, United States
Champaign, Illinois, United States
Piura, , Peru
Conyers, Georgia, United States
Rožňava, , Slovakia
Frýdek Místek, , Czechia
Woodbridge, Virginia, United States
Riverview, Florida, United States
Chester, Pennsylvania, United States
Naka, , Japan
Kuantan, , Malaysia
Maringá, , Brazil
Hengyang, , China
Jilemnice, , Czechia
Dunaújváros, , Hungary
Sanya, , China
Kahramanmaras, , Turkey
Reinfeld (Holstein), , Germany
Mendoza, , Argentina
Jodhpur, , India
Shenyang, , China
Peachtree Corners, Georgia, United States
Chongqing, , China
Yung Kang City, , Taiwan
Almeria, , Spain
Newton, , South Africa
La Plata, , Argentina
Hochiminh City, , Vietnam
Urayasu, , Japan
Marugame Shi, , Japan
Kofu Shi, , Japan
Phutthamonthon, , Thailand
Calicut, , India
Uijeongbu, , Korea, Republic Of
Toulouse, , France
Matsuyama City, , Japan
Panjin, , China
Cambridge, , United Kingdom
Adapazarı, , Turkey
Sevilla, , Spain
Kota Kinabalu, , Malaysia
Pune, , India
Petah Tikva, , Israel
Timisoara, , Romania
Montréal, Quebec, Canada
Caba, , Argentina
Campina Grande Do Sul, , Brazil
Midrand, , South Africa
Holbæk, , Denmark
Da Nang, , Vietnam
Muang, , Thailand
Kumagaya Shi, , Japan
London, , United Kingdom
Chennai, , India
Caba, , Argentina
Wrocław, , Poland
Searcy, Arkansas, United States
Middletown, New York, United States
Ciudad Autonoma De Bs As, , Argentina
Police Nad Metují, , Czechia
Leipzig, , Germany
Völklingen, , Germany
Heraclion, , Greece
Bangalore, , India
Hyderabad, , India
Chiavari, , Italy
Desio, , Italy
żywiec, , Poland
Myjava, , Slovakia
Danderyd, , Sweden
Gavle, , Sweden
Afyonkarahisar, , Turkey
Chernivtsі, , Ukraine
Nanchang, , China
Victoria, , Chile
Araucania, , Chile
Brest Cedex, , France
Montréal, Quebec, Canada
Guiyang, , China
New Britain, Connecticut, United States
Huntley, Illinois, United States
Upper Marlboro, Maryland, United States
Niagara Falls, New York, United States
Sioux Falls, South Dakota, United States
Fortaleza, , Brazil
Copenhagen E, , Denmark
Annonay Cedex, , France
Le Puy En Velay, , France
Marseille Cedex 6, , France
Kawaguchi, , Japan
Sapporo, , Japan
Laguna, , Philippines
Kyiv, , Ukraine
Leipzig, , Germany
Can Tho, , Vietnam
Bois Guillaume, , France
Gävle, , Sweden
Taoyuan City, , Taiwan
Quimper, , France
Hilversum, , Netherlands
Lanus, , Argentina
Taichung City, , Taiwan
Ciudad De Buenos Aires, , Argentina
Surrey, British Columbia, Canada
Hounslow, , United Kingdom
Olsztyn, , Poland
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported