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 October 02, 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
Leipzig, Germany
Mohali, India
Seoul, Korea, Republic Of
Cluj Napoca, Romania
Kosice, Slovakia
Los Alamitos, California, United States
Hazel Crest, Illinois, United States
Hutchinson, Kansas, United States
Statesville, North Carolina, United States
Manassas, Virginia, United States
Caba, Argentina
Mendoza, Argentina
Veliko Tarnovo, Bulgaria
Yambol, Bulgaria
Vancouver, British Columbia, Canada
Urumqi, China
Frýdek Místek, Czechia
Jilemnice, Czechia
Uherske Hradiste, Czechia
Aalborg, Denmark
Esbjerg, Denmark
Falkensee, Germany
Hamburg, Germany
Herne, Germany
Mainz, Germany
Wiesbaden, Germany
Witten, Germany
Alexandroupolis, Greece
Kecskemét, Hungary
Nyíregyháza, Hungary
Ahmedabad, India
Ramat Gan, Israel
Chiavari, Italy
Seremban, Malaysia
Taiping, Malaysia
Hilversum, Netherlands
Krakow, Poland
Lodz, Poland
Lublin, Poland
Warszawa, Poland
Trnava, Slovakia
Durban, South Africa
Lenasia, South Africa
Varberg, Sweden
Yung Kang City, Taiwan
Adapazarı, Turkey
Istanbul, Turkey
Kahramanmaras, Turkey
Kayseri, Turkey
Kocaeli, Turkey
Uzhhorod, Ukraine
Newcastle Under Lyme, United Kingdom
Wolverhampton, United Kingdom
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Phoenix, Arizona, United States
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Lincoln, California, United States
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Hialeah, Florida, United States
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Houston, Texas, United States
Humble, Texas, United States
Brussel, Belgium
Liège, Belgium
Saint John, Canada
Hangzhou, China
Krnov, Czechia
Nachod, Czechia
Praha 10, Czechia
Herning, Denmark
Holbæk, Denmark
Münster, Germany
Calicut, India
Chennai, India
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Rehovot, Israel
Tel Aviv, Israel
Amersfoort, Netherlands
Tilburg, Netherlands
Utrecht, Netherlands
Ruda śląska, Poland
łódź, Poland
żywiec, Poland
Benoni, South Africa
Newton, South Africa
Chiang Mai, Thailand
Lake Worth, Florida, United States
Leuven, Belgium
Roeselare, Belgium
Lom, Bulgaria
Patras, Greece
Pécs, Hungary
Bangalore, India
Chuo Ku, Japan
Arequipa, Peru
Bucuresti, Romania
Badalona, Spain
Hat Yai, Thailand
Chernivtsі, Ukraine
Vinnytsia, Ukraine
Bristol, United Kingdom
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Rozzano, Italy
San Giovanni Rotondo, Italy
Novi Sad, Serbia
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Cape Town, South Africa
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Madrid, Spain
Gavle, Sweden
Göteborg, Sweden
Linkoping, Sweden
Phutthamonthon, Thailand
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San Nicolás, Argentina
Gent, Belgium
Police Nad Metují, Czechia
Praha 6, Czechia
Herlev, Denmark
Reinfeld (Holstein), Germany
Ashkelon, Israel
Torino, Italy
Nitra, Slovakia
Puchov, Slovakia
Columbus, Ohio, United States
Uniontown, Pennsylvania, United States
Arlington, Texas, United States
Kortrijk, Belgium
Gotse Delchev, Bulgaria
Kozloduy, Bulgaria
Waterloo, Ontario, Canada
Quebec, Canada
Amberg, Germany
Bad Oeynhausen, Germany
Berlin, Germany
Essen, Germany
Uijeongbu, Korea, Republic Of
Wonju Si, Korea, Republic Of
Kuantan, Malaysia
Hardenberg, Netherlands
Stanger, South Africa
Malaga, Spain
Palma Demallorca, Spain
Taipei, Taiwan
Adana, Turkey
Afyonkarahisar, Turkey
Jacksonville, Florida, United States
Ciudad Autonoma De Bs As, Argentina
Cordoba, Argentina
Ieper, Belgium
Ronse, Belgium
Aarhus N, Denmark
Odense, Denmark
Ioannina, Greece
Jerusalem, Israel
Kfar Saba, Israel
Dordrecht, Netherlands
Roosendaal, Netherlands
Iasi, Romania
Gdynia, Poland
Kraków, Poland
Banska Bystrica, Slovakia
Tczew, Poland
Dolný Kubín, Slovakia
Ankara, Turkey
Vinnytsya, Ukraine
Liverpool, United Kingdom
Rožňava, Slovakia
L'hospitalet De Llobregat, Spain
Ho Chi Minh, Vietnam
Da Nang, Vietnam
Piura, Peru
Belgrade, Serbia
Orlando, Florida, United States
Székesfehérvár, Hungary
Olomouc, Czechia
Heraclion, Greece
Jodhpur, India
Bloemfontein, South Africa
Valencia, Spain
Danderyd, Sweden
Bucharest, Romania
Nis, Serbia
Taipei City, Taiwan
Ternopil, Ukraine
Liege, Belgium
Szczecin, Poland
Wrocław, Poland
Midrand, South Africa
Uppsala, Sweden
Milano, Italy
Parma, Italy
Bien Hoa, Vietnam
Rzeszów, Poland
Kaiserslautern, Germany
Schwerin, Germany
Kuala Lumpur, Malaysia
La Coruna, Spain
Málaga, Spain
Kaohsiung, Taiwan
Taichung, Taiwan
Muang, Thailand
Rättvik, Sweden
Bursa, Turkey
Ivano Frankivsk, Ukraine
Ratchathewi, Thailand
Sherbrooke, Quebec, Canada
La Plata, Argentina
Nanjing, China
Kolkata, India
Praha 4, Czechia
Belagavi, India
Antalya, Turkey
Hollywood, Florida, United States
Detroit, Michigan, United States
Pamplona, Spain
Honolulu, Hawaii, United States
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Aalst, Belgium
Bonheiden, Belgium
Kaohsiung City, Taiwan
Plovdiv, Bulgaria
Sliven, Bulgaria
São Paulo, Brazil
Alkmaar, Netherlands
Almere, Netherlands
Lima, Peru
Olsztyn, Poland
London, Ontario, Canada
Presov, Slovakia
Zilina, Slovakia
Poznań, Poland
Sevilla, Spain
Aachen, Germany
München, Germany
Ulm, Germany
Kragujevac, Serbia
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Stockholm, Sweden
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Siófok, Hungary
Pune, India
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Martin, Slovakia
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Amiens Cedex 1, France
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Zhengzhou, China
Marseille, France
Montpellier, France
Aarhus, Denmark
Copenhagen E, Denmark
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Tours, France
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Hiroshima Shi, Japan
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Osaka, Japan
Davao City, Philippines
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Laguna, Philippines
Riyadh, Saudi Arabia
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Lexington, Kentucky, United States
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Panjin, China
Santiago, Chile
Wuxi, China
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Victoria, Chile
Chuangchun, China
Harrow, United Kingdom
Toride Shi, Japan
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Yaizu Shi, Japan
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Pontoise, France
Dongguan, China
Lanzhou, China
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Baotou, China
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Matsuyama City, Japan
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Chrzanów, Poland
Parow, South Africa
Nottingham, United Kingdom
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Conyers, Georgia, United States
Dundee, United Kingdom
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Pleven, Bulgaria
Vijayawada, India
Daito Shi, Japan
Kamakura Shi, Japan
Hengyang, China
London, United Kingdom
Obihiro Shi, Japan
Ueda Shi, Japan
Buffalo, New York, United States
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Chorrillos, Peru
Laval, Quebec, Canada
Yangsan Si, Korea, Republic Of
Changsha, China
Sanya, China
Budapest, Hungary
Haifa, Israel
Montreal, Quebec, Canada
Ha Noi, Vietnam
Macon, Georgia, United States
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Nishinomiya Shi, Japan
Marugame Shi, Japan
Peachtree Corners, Georgia, United States
Eatontown, New Jersey, United States
Binghamton, New York, United States
Rockville Centre, New York, United States
Parkville, Australia
Perth, Australia
Winnipeg, Manitoba, Canada
Xian, China
Berlin, Germany
Athens, Greece
Madurai, India
Fujisawa Shi, Japan
Sapporo, Japan
Fort Lauderdale, Florida, United States
Fort Wayne, Indiana, United States
New Bedford, Massachusetts, United States
Surprise, Arizona, United States
Cebu City, Philippines
Quezon City, Philippines
Port Orange, Florida, United States
Evansville, Indiana, United States
Tucson, Arizona, United States
Lake City, Florida, United States
Memphis, Tennessee, United States
Burlington, Vermont, United States
Riverview, Florida, United States
Guiyang, China
Charleston, South Carolina, United States
Chattanooga, Tennessee, United States
Fairfax, Virginia, United States
Hengyang, China
New Taipei, Taiwan
Taoyuan City, Taiwan
Gosford, Australia
Dupnitsa, Bulgaria
Changzhou, China
Surrey, British Columbia, Canada
Saint Louis, Missouri, United States
San Fernando, Philippines
Dammam, Saudi Arabia
Huntington Park, California, United States
Edgewater, Florida, United States
Lufkin, Texas, United States
Melbourne, Florida, United States
Woodbridge, Virginia, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Rockford, Illinois, United States
Zhengzhou, China
Bois Guillaume, France
Boulogne Billancourt Cedex, France
Clermont Ferrand, France
Edmonton, Alberta, Canada
Viña Del Mar, Chile
Guangzhou, China
Haikou, China
Kawaguchi, Japan
La Roche Sur Yon, France
Kurume Shi, Japan
Kyoto Shi, Japan
Naka, Japan
Seoul, Korea, Republic Of
Klang, Malaysia
Košice, Slovakia
Marseille Cedex 5, France
Gävle, Sweden
Toulouse, France
Muang, Thailand
Hai Phong, Vietnam
Chester, Pennsylvania, United States
Ubonratchathani, Thailand
Austin, Texas, United States
Taichung City, Taiwan
Xiamen, China
Can Tho, Vietnam
Lanham, Maryland, United States
Boston, Massachusetts, United States
New York, New York, United States
Kingsport, Tennessee, United States
Caba, Argentina
Darlinghurst, Australia
Changchun, China
Curitiba, Brazil
Sao Jose Do Rio Preto, Brazil
Houston, Texas, United States
Toronto, Ontario, Canada
Lille, France
Leicester, United Kingdom
Lanus, Argentina
Denver, Colorado, United States
Vancouver, British Columbia, Canada
Daejeon, Korea, Republic Of
Gwangju, Korea, Republic Of
Seoul, Korea, Republic Of
Stoney Creek, Ontario, Canada
Oradea, Romania
Timisoara, Romania
Kyiv, Ukraine
Pasadena, Texas, United States
Pingxiang, China
Montréal, Quebec, Canada
Petah Tikva, Israel
Marseille, France
Quimper, France
Vandoeuvre Les Nancy, France
Anyang Si, Korea, Republic Of
Busan, Korea, Republic Of
Olsztyn, Poland
São José Do Rio Preto, Brazil
Praha, Czechia
Bordeaux, France
Cheonan Si, Korea, Republic Of
Hilversum, Netherlands
Kaohsiung, Taiwan
Taoyuan, Taiwan
Clermont Ferrand, France
A Coruña, Spain
L' Hospitalet De Llobregat, Spain
Ansan Si, Korea, Republic Of
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported