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Search / Trial NCT06268873

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

Chronic Kidney Disease Hypertension Blood Pressure Baxdrostat Dapagliflozin

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.

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

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Kayseri, Turkey

Kocaeli, Turkey

Uzhhorod, Ukraine

Newcastle Under Lyme, United Kingdom

Wolverhampton, United Kingdom

Hochiminh City, Vietnam

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Searcy, Arkansas, United States

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Chicago, Illinois, United States

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

New Delhi, India

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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Oldenburg, Germany

Dehradun, India

Hyderabad, India

Rozzano, Italy

San Giovanni Rotondo, Italy

Novi Sad, Serbia

Myjava, Slovakia

Cape Town, South Africa

Lugo, Spain

Madrid, Spain

Gavle, Sweden

Göteborg, Sweden

Linkoping, Sweden

Phutthamonthon, Thailand

Fullerton, California, United States

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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

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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

Kansas City, Missouri, United States

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

Oshawa, Ontario, Canada

Békéscsaba, Hungary

Stockholm, Sweden

Wilmington, North Carolina, United States

Wollongong, Australia

Budapest, Hungary

Siófok, Hungary

Pune, India

Lucenec, Slovakia

Martin, Slovakia

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Thessaloniki, Greece

Bangkok, Thailand

Mannheim, Germany

Szeged, Hungary

Maumee, Ohio, United States

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Coimbatore, India

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Guiyang, China

Sendai Shi, Japan

Tsu Shi, Japan

Yokohama Shi, Japan

Catanzaro, Italy

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Harderwijk, Netherlands

Targu Mures, Romania

Fairhope, Alabama, United States

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Buenos Aires, Argentina

Birtinya, Australia

Clayton, Australia

St Leonards, Australia

Belem, Brazil

Campina Grande Do Sul, Brazil

Campinas, Brazil

Fortaleza, Brazil

Sioux Falls, South Dakota, United States

Joinville, Brazil

Maringá, Brazil

Halifax, Nova Scotia, Canada

Sydney, Nova Scotia, Canada

Brampton, Ontario, Canada

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Porto Alegre, Brazil

Chengdu, China

Araucania, Chile

Chongqing, China

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Shenyang, China

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Wuhan, China

Huai'an, China

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Amiens Cedex 1, France

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Lille Cedex, France

Marseille Cedex 6, France

Zhengzhou, China

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Montpellier, France

Aarhus, Denmark

Copenhagen E, Denmark

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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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Nanchang, China

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Santiago, Chile

Wuxi, China

Takatsuki Shi, Japan

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Chuangchun, China

Harrow, United Kingdom

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Yaizu Shi, Japan

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Pontoise, France

Dongguan, China

Lanzhou, China

Goyang Si, Korea, Republic Of

Huntley, Illinois, United States

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Kogarah, Australia

Baotou, China

Foshan, China

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Matsuyama City, Japan

Sarcelles, France

Dresden, Germany

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Beijing, China

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Chrzanów, Poland

Parow, South Africa

Nottingham, United Kingdom

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Conyers, Georgia, United States

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Pleven, Bulgaria

Vijayawada, India

Daito Shi, Japan

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Hengyang, China

London, United Kingdom

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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

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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

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported