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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 22, 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

Kahramanmaras, Turkey

Kayseri, Turkey

Kocaeli, Turkey

Uzhhorod, Ukraine

Newcastle Under Lyme, United Kingdom

Wolverhampton, United Kingdom

Hochiminh City, Vietnam

Phoenix, Arizona, United States

Searcy, Arkansas, United States

Lincoln, California, United States

Torrance, California, United States

Arvada, Colorado, United States

Hialeah, Florida, United States

Champaign, Illinois, United States

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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Tarzana, California, United States

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Middletown, New York, United States

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Mar Del Plata, Argentina

Stara Zagora, Bulgaria

Nürnberg, Germany

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

New Bern, North Carolina, United States

San Antonio, Texas, United States

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

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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

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

Ankara, Turkey

Vinnytsya, Ukraine

Liverpool, United Kingdom

Dolný Kubín, Slovakia

Da Nang, Vietnam

Ho Chi Minh, Vietnam

Olomouc, Czechia

Rožňava, Slovakia

Heraclion, Greece

L'hospitalet De Llobregat, Spain

Piura, Peru

Belgrade, Serbia

Jodhpur, India

Orlando, Florida, United States

Bucharest, Romania

Székesfehérvár, Hungary

Nis, Serbia

Bloemfontein, South Africa

Valencia, Spain

Ternopil, Ukraine

Danderyd, Sweden

Taipei City, Taiwan

Milano, Italy

Liege, Belgium

Szczecin, Poland

Parma, Italy

Rzeszów, Poland

Wrocław, Poland

Kaiserslautern, Germany

Schwerin, Germany

Midrand, South Africa

Uppsala, Sweden

Bien Hoa, Vietnam

Kuala Lumpur, Malaysia

Kaohsiung, Taiwan

La Coruna, Spain

Málaga, Spain

Taichung, Taiwan

Muang, Thailand

Rättvik, Sweden

Bursa, Turkey

Ivano Frankivsk, Ukraine

Ratchathewi, Thailand

La Plata, Argentina

Praha 4, Czechia

Belagavi, India

Sherbrooke, Quebec, Canada

Nanjing, China

Kolkata, India

Antalya, Turkey

Hollywood, Florida, United States

Kaohsiung City, Taiwan

Detroit, Michigan, United States

Honolulu, Hawaii, United States

Pamplona, Spain

Kansas City, Missouri, United States

Plovdiv, Bulgaria

Aalst, Belgium

Bonheiden, Belgium

São Paulo, Brazil

Sliven, Bulgaria

London, Ontario, Canada

Olsztyn, Poland

Alkmaar, Netherlands

Poznań, Poland

Kragujevac, Serbia

Almere, Netherlands

Presov, Slovakia

Lima, Peru

Zilina, Slovakia

Sevilla, Spain

Oshawa, Ontario, Canada

Békéscsaba, Hungary

Stockholm, Sweden

Aachen, Germany

München, Germany

Ulm, Germany

Völklingen, Germany

Pune, India

Wilmington, North Carolina, United States

Wollongong, Australia

Budapest, Hungary

Siófok, Hungary

San Francisco, California, United States

Maumee, Ohio, United States

Lucenec, Slovakia

Glasgow, United Kingdom

Martin, Slovakia

Bangkok, Thailand

Thessaloniki, Greece

Mannheim, Germany

Szeged, Hungary

Miami Lakes, Florida, United States

Sao Paulo, Brazil

Coimbatore, India

Sioux Falls, South Dakota, United States

Kyiv, Ukraine

Guiyang, China

Sendai Shi, Japan

Tsu Shi, Japan

Yokohama Shi, Japan

Catanzaro, Italy

Nagoya Shi, Japan

Leipzig, Germany

Harderwijk, Netherlands

Fairhope, Alabama, United States

Targu Mures, Romania

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Pontiac, Michigan, United States

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Newport News, Virginia, United States

Richmond, Virginia, United States

Buenos Aires, Argentina

Dallas, Texas, United States

Birtinya, Australia

Clayton, Australia

Fortaleza, Brazil

Joinville, Brazil

Maringá, Brazil

St Leonards, Australia

Porto Alegre, Brazil

Halifax, Nova Scotia, Canada

Belem, Brazil

Campina Grande Do Sul, Brazil

Campinas, Brazil

Sydney, Nova Scotia, Canada

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Concord, Ontario, Canada

Chengdu, China

Araucania, Chile

Chongqing, China

Shanghai, China

Shenyang, China

Shenzhen, China

Wuhan, China

Yantai, China

Huai'an, China

Yinchuan, China

Zhengzhou, China

Amiens Cedex 1, France

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Bordeaux Cedex, France

Le Puy En Velay, France

Lille Cedex, France

Marseille Cedex 6, France

Marseille, France

Aarhus, Denmark

Montpellier, France

Copenhagen E, Denmark

Nimes, France

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Tours, France

Quimper Cedex, France

Valenciennes, France

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Kofu Shi, Japan

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Hiroshima, Japan

Oita Shi, Japan

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Ina Shi, Japan

Osaka, Japan

Shizuoka Shi, Japan

Shinjyuku Ku, Japan

Tsu Shi, Japan

Davao City, Philippines

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Laguna, Philippines

Riyadh, Saudi Arabia

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Cambridge, United Kingdom

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Urayasu, Japan

Santiago, Chile

Bethesda, Maryland, United States

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Victoria, Chile

Chuangchun, China

Lewisville, Texas, United States

Nanchang, China

Panjin, China

Wuxi, China

Odessa, Texas, United States

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Takatsuki Shi, Japan

Toride Shi, Japan

Dongguan, China

Toyota Shi, Japan

Yaizu Shi, Japan

Brest Cedex, France

Lanzhou, China

Goyang Si, Korea, Republic Of

Huntley, Illinois, United States

Kogarah, Australia

Baotou, China

Foshan, China

Pontoise, France

Sarcelles, France

Sakai Shi, Japan

Kasugai Shi, Japan

Matsuyama City, Japan

Chrzanów, Poland

Parow, South Africa

Beijing, China

Dresden, Germany

Dunaújváros, Hungary

Nottingham, United Kingdom

Fukuoka Shi, Japan

Dundee, United Kingdom

London, United Kingdom

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Pleven, Bulgaria

Vijayawada, India

Daito Shi, Japan

Kamakura Shi, Japan

Hengyang, China

Conyers, Georgia, United States

Obihiro Shi, Japan

Ueda Shi, Japan

Yangsan Si, Korea, Republic Of

Buffalo, New York, United States

Salt Lake City, Utah, United States

Salem, Virginia, United States

Kota Kinabalu, Malaysia

Chorrillos, Peru

Roseburg, Oregon, United States

Changsha, China

Sanya, China

Budapest, Hungary

Haifa, Israel

Ha Noi, Vietnam

Manhasset, New York, United States

Nishinomiya Shi, Japan

Macon, Georgia, United States

Laval, Quebec, Canada

Montreal, Quebec, Canada

Marugame Shi, Japan

Peachtree Corners, Georgia, United States

Rockville Centre, New York, United States

Xian, China

Berlin, Germany

Eatontown, New Jersey, United States

Athens, Greece

Binghamton, New York, United States

Madurai, India

Parkville, Australia

Sapporo, Japan

Perth, Australia

Winnipeg, Manitoba, Canada

Fujisawa Shi, 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

Memphis, Tennessee, United States

Evansville, Indiana, United States

Burlington, Vermont, United States

Tucson, Arizona, United States

Guiyang, China

Riverview, Florida, United States

Charleston, South Carolina, United States

Chattanooga, Tennessee, United States

Fairfax, Virginia, United States

Lake City, Florida, United States

Hengyang, China

New Taipei, Taiwan

Changzhou, China

Taoyuan City, Taiwan

Gosford, Australia

Dupnitsa, Bulgaria

Surrey, British Columbia, Canada

San Fernando, Philippines

Dammam, Saudi Arabia

Saint Louis, Missouri, United States

Melbourne, Florida, United States

Huntington Park, California, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Rockford, Illinois, United States

Lufkin, Texas, United States

Edgewater, Florida, United States

Woodbridge, Virginia, United States

Zhengzhou, China

Bois Guillaume, France

Boulogne Billancourt Cedex, France

Clermont Ferrand, France

Edmonton, Alberta, Canada

La Roche Sur Yon, France

Viña Del Mar, Chile

Guangzhou, China

Marseille Cedex 5, France

Toulouse, France

Haikou, China

Seoul, Korea, Republic Of

Kawaguchi, Japan

Kurume Shi, Japan

Kyoto Shi, Japan

Naka, Japan

Klang, Malaysia

Košice, Slovakia

Hai Phong, Vietnam

Gävle, Sweden

Chester, Pennsylvania, United States

Muang, Thailand

Ubonratchathani, Thailand

Lanham, Maryland, United States

Curitiba, Brazil

Sao Jose Do Rio Preto, Brazil

Toronto, Ontario, Canada

Austin, Texas, United States

Xiamen, China

Taichung City, Taiwan

Can Tho, Vietnam

Caba, Argentina

Boston, Massachusetts, United States

New York, New York, United States

Kingsport, Tennessee, United States

Darlinghurst, Australia

Changchun, China

Houston, Texas, United States

Lille, France

Denver, Colorado, United States

Leicester, United Kingdom

Lanus, Argentina

Daejeon, Korea, Republic Of

Gwangju, Korea, Republic Of

Seoul, Korea, Republic Of

Oradea, Romania

Vancouver, British Columbia, Canada

Timisoara, Romania

Stoney Creek, Ontario, Canada

Montréal, Quebec, Canada

Kyiv, Ukraine

Petah Tikva, Israel

Anyang Si, Korea, Republic Of

Busan, Korea, Republic Of

Cheonan Si, Korea, Republic Of

Hilversum, Netherlands

Pasadena, Texas, United States

Pingxiang, China

Marseille, France

Quimper, France

Vandoeuvre Les Nancy, France

Olsztyn, Poland

Kaohsiung, Taiwan

Taoyuan, Taiwan

Ansan Si, Korea, Republic Of

São José Do Rio Preto, Brazil

Praha, Czechia

Bordeaux, France

Clermont Ferrand, France

A Coruña, Spain

L' Hospitalet De Llobregat, Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported