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 November 12, 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
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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
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Krakow, Poland
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Trnava, Slovakia
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Lenasia, South Africa
Varberg, Sweden
Yung Kang City, Taiwan
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Uzhhorod, Ukraine
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Praha 10, Czechia
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Newton, South Africa
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Bangalore, India
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Gent, Belgium
Police Nad Metují, Czechia
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Reinfeld (Holstein), Germany
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Torino, Italy
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Puchov, Slovakia
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Gotse Delchev, Bulgaria
Kozloduy, Bulgaria
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Bad Oeynhausen, Germany
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Essen, Germany
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Hardenberg, Netherlands
Gdynia, Poland
Kraków, Poland
Tczew, Poland
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
Banska Bystrica, Slovakia
Dolný Kubín, Slovakia
Rožňava, Slovakia
L'hospitalet De Llobregat, Spain
Ankara, Turkey
Vinnytsya, Ukraine
Liverpool, United Kingdom
Da Nang, Vietnam
Ho Chi Minh, Vietnam
Olomouc, Czechia
Heraclion, Greece
Jodhpur, India
Piura, Peru
Belgrade, Serbia
Orlando, Florida, United States
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Bucharest, Romania
Nis, Serbia
Bloemfontein, South Africa
Valencia, Spain
Danderyd, Sweden
Taipei City, Taiwan
Ternopil, Ukraine
Liege, Belgium
Milano, Italy
Parma, Italy
Rzeszów, Poland
Szczecin, Poland
Wrocław, Poland
Midrand, South Africa
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Bien Hoa, Vietnam
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Schwerin, Germany
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La Coruna, Spain
Málaga, Spain
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Kaohsiung, Taiwan
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Lima, Peru
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Changsha, China
Sanya, China
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Haifa, Israel
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Sapporo, Japan
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Surprise, Arizona, United States
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New Bedford, Massachusetts, United States
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Guiyang, China
Cebu City, Philippines
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Port Orange, Florida, United States
Evansville, Indiana, United States
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Lake City, Florida, United States
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Chattanooga, Tennessee, United States
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Changzhou, China
Hengyang, China
New Taipei, Taiwan
Taoyuan City, Taiwan
Gosford, Australia
Dupnitsa, Bulgaria
Surrey, British Columbia, Canada
Saint Louis, Missouri, United States
San Fernando, Philippines
Dammam, Saudi Arabia
Huntington Park, California, United States
Edgewater, Florida, United States
Melbourne, Florida, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Rockford, Illinois, United States
Lufkin, Texas, United States
Woodbridge, Virginia, United States
Edmonton, Alberta, Canada
Viña Del Mar, Chile
Guangzhou, China
Haikou, China
Zhengzhou, China
Bois Guillaume, France
Boulogne Billancourt Cedex, France
Clermont Ferrand, France
La Roche Sur Yon, France
Marseille Cedex 5, France
Toulouse, France
Kawaguchi, Japan
Kurume Shi, Japan
Kyoto Shi, Japan
Naka, Japan
Seoul, Korea, Republic Of
Klang, Malaysia
Košice, Slovakia
Gävle, Sweden
Muang, Thailand
Ubonratchathani, Thailand
Hai Phong, Vietnam
Chester, Pennsylvania, United States
Lanham, Maryland, United States
Curitiba, Brazil
Sao Jose Do Rio Preto, Brazil
Toronto, Ontario, Canada
Austin, Texas, United States
Taichung City, Taiwan
Xiamen, China
Can Tho, Vietnam
Boston, Massachusetts, United States
New York, New York, United States
Kingsport, Tennessee, United States
Caba, Argentina
Darlinghurst, Australia
Changchun, China
Houston, Texas, United States
Leicester, United Kingdom
Lille, France
Denver, Colorado, United States
Lanus, Argentina
Vancouver, British Columbia, Canada
Stoney Creek, Ontario, Canada
Montréal, Quebec, Canada
Daejeon, Korea, Republic Of
Gwangju, Korea, Republic Of
Seoul, Korea, Republic Of
Oradea, Romania
Timisoara, Romania
Kyiv, Ukraine
Pasadena, Texas, United States
Pingxiang, China
Marseille, France
Quimper, France
Vandoeuvre Les Nancy, France
Petah Tikva, Israel
Anyang Si, Korea, Republic Of
Busan, Korea, Republic Of
Cheonan Si, Korea, Republic Of
Hilversum, Netherlands
Olsztyn, Poland
São José Do Rio Preto, Brazil
Praha, Czechia
Bordeaux, France
Clermont Ferrand, France
A Coruña, Spain
L' Hospitalet De Llobregat, Spain
Kaohsiung, Taiwan
Taoyuan, Taiwan
Ansan Si, Korea, Republic Of
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported