A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Launched by ASTRAZENECA · Dec 16, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effectiveness and safety of a new treatment called Baxdrostat when combined with another medication, Dapagliflozin. The goal is to see how well this combination can help improve kidney function and reduce the risk of heart-related problems in people who have chronic kidney disease and high blood pressure. The study is open to adults aged 18 and older who meet specific health criteria, including certain levels of kidney function and blood pressure.
Participants in this trial can expect to receive either the new treatment combination or a placebo (a dummy treatment) over a period of time, while doctors monitor their health closely. To be eligible, individuals must have stable kidney function and blood pressure, and they should not have certain medical conditions that could complicate the study. This trial is an important step in finding better ways to manage kidney disease and heart health for those affected.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.
- 2. Participants with:
- • 1. eGFR ≥ 30 and \< 60 mL/min/1.73 m2 (local or central laboratory values) AND UACR ≥ 30 mg/g (3.39 mg/mmol) and \< 500 mg/g (56.5 mg/mmol) (central laboratory values only), or
- • 2. eGFR ≥ 30 and ≤ 75 mL/min/1.73 m2 (local or central laboratory values) AND UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) or UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local or central laboratory values).
- • 3. \[obsolete\]
- • 4. Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit.
- • 5. Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit.
- 6. Participants with:
- • 1. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central laboratory values).
- • 2. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR \< 45 mL/min/1.73 m2 (local or central laboratory values).
- Exclusion Criteria:
- • 1. Systolic blood pressure \> 180 mmHg, or diastolic BP \> 110 mmHg at screening.
- • 2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months prior to screening.
- • 3. Serum sodium \< 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).
- 4. T1DM:
- • 1. 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.
- • 2. 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.
- • 5 Uncontrolled T2DM with HbA1c \> 10.5% (\> 91 mmol/mol) (central or local laboratory values obtained within 3 months prior to screening or at the Screening Visit).
- • 6 New York Heart Association functional HF class IV at screening.
- • 7 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.
- • 8 Documented history of adrenal insufficiency.
- • 9 Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
- • 10 Any acute kidney injury within 3 months prior to the Screening Visit.
- • 11 History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).
- • 12 Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1).
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
Maywood, Illinois, United States
Sofia, , Bulgaria
Port Charlotte, Florida, United States
Nashville, Tennessee, United States
Columbia, South Carolina, United States
Pasadena, Texas, United States
Plovdiv, , Bulgaria
Detroit, Michigan, United States
Hasselt, , Belgium
Liège, , Belgium
Barretos, , Brazil
Nyíregyháza, , Hungary
Székesfehérvár, , Hungary
A Coruña, , Spain
Sevilla, , Spain
San Diego, California, United States
Evansville, Indiana, United States
Ocoee, Florida, United States
New York, New York, United States
Columbus, Ohio, United States
Berlin, , Germany
Fullerton, California, United States
Los Alamitos, California, United States
Las Vegas, Nevada, United States
Canton, Ohio, United States
Leuven, , Belgium
Namur, , Belgium
Roeselare, , Belgium
Quebec, , Canada
Hannover, , Germany
Jerusalem, , Israel
Padova, , Italy
Denver, Colorado, United States
Varna, , Bulgaria
Veliko Tarnovo, , Bulgaria
Dundee, , United Kingdom
Iowa City, Iowa, United States
Paris, , France
Torino, , Italy
London, , United Kingdom
Clermont Ferrand, , France
Essen, , Germany
Athens, , Greece
Nieuwegein, , Netherlands
Málaga, , Spain
Burlington, Vermont, United States
Rehovot, , Israel
Albany, New York, United States
Oshawa, Ontario, Canada
Barranquilla, , Colombia
Jacksonville Beach, Florida, United States
Melbourne, Florida, United States
Rockford, Illinois, United States
Wichita, Kansas, United States
New Bern, North Carolina, United States
Winston Salem, North Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Aalst, , Belgium
Genk, , Belgium
London, Ontario, Canada
Montreal, Quebec, Canada
Santiago, , Chile
Herlev, , Denmark
Vandoeuvre Les Nancy, , France
Heidelberg, , Germany
Mainz, , Germany
Stuttgart, , Germany
Zalaegerszeg, , Hungary
Pavia, , Italy
Groningen, , Netherlands
Presov, , Slovakia
Uppsala, , Sweden
Glasgow, , United Kingdom
Nanning, , China
Ann Arbor, Michigan, United States
Chattanooga, Tennessee, United States
East Providence, Rhode Island, United States
Boynton Beach, Florida, United States
Novara, , Italy
Chihuahua, , Mexico
Boston, Massachusetts, United States
Dallas, Texas, United States
Kortrijk, , Belgium
Karlstad, , Sweden
Reims, , France
Bamberg, , Germany
Görlitz, , Germany
Ulm, , Germany
Wermsdorf, , Germany
Ioannina, , Greece
Patras, , Greece
Thessaloniki, , Greece
Foggia, , Italy
Badalona, , Spain
Maastricht, , Netherlands
Roma, , Italy
Wilmington, North Carolina, United States
Beverly Hills, California, United States
Tel Aviv, , Israel
Szczecin, , Poland
Laval, Quebec, Canada
Miami Lakes, Florida, United States
Greenville, North Carolina, United States
Montreal, Quebec, Canada
Halifax, Nova Scotia, Canada
Leiden, , Netherlands
Manila, , Philippines
Valencia, , Spain
Providence, Rhode Island, United States
Perth, , Australia
Adelaide, , Australia
Nahariya, , Israel
Suceava, , Romania
Atlanta, Georgia, United States
Hickory, North Carolina, United States
Tours, , France
Bordeaux Cedex, , France
Hollywood, Florida, United States
Newport News, Virginia, United States
Sint Truiden, , Belgium
New Delhi, , India
Belgrade, , Serbia
Kragujevac, , Serbia
Nis, , Serbia
Novi Sad, , Serbia
Durban, , South Africa
Budapest, , Hungary
Lublin, , Poland
Fort Lauderdale, Florida, United States
Hutchinson, Kansas, United States
Saint Louis, Missouri, United States
Charleston, South Carolina, United States
Ieper, , Belgium
Cebu City, , Philippines
Quezon City, , Philippines
Bloemfontein, , South Africa
Rozzano, , Italy
Cincinnati, Ohio, United States
Fairfax, Virginia, United States
Bologna, , Italy
Salford, , United Kingdom
Szolnok, , Hungary
Nice, , France
West Des Moines, Iowa, United States
Praha 6, , Czechia
Tucson, Arizona, United States
Vancouver, British Columbia, Canada
Nantes Cedex 1, , France
Morehead City, North Carolina, United States
Majadahonda, , Spain
San Antonio, Texas, United States
Modena, , Italy
Linköping, , Sweden
Seoul, , Korea, Republic Of
Winter Haven, Florida, United States
Norfolk, Nebraska, United States
Albany, New York, United States
Iloilo City, , Philippines
Taipei, , Taiwan
Bangkok, , Thailand
Ubonratchathani, , Thailand
Herning, , Denmark
Durango, , Mexico
Dordrecht, , Netherlands
Amsterdam, , Netherlands
Minato Ku, , Japan
Metairie, Louisiana, United States
Statesville, North Carolina, United States
Knoxville, Tennessee, United States
Buenos Aires, , Argentina
Elizabeth Vale, , Australia
Ronse, , Belgium
Gabrovo, , Bulgaria
Sliven, , Bulgaria
Beijing, , China
Chongqing, , China
Suzhou, , China
Wuhan, , China
Yinchuan, , China
Kaposvár, , Hungary
Busan, , Korea, Republic Of
Kuala Lumpur, , Malaysia
Guadalajara, , Mexico
Amersfoort, , Netherlands
Grodzisk Mazowiecki, , Poland
Cluj Napoca, , Romania
Zilina, , Slovakia
Lenasia, , South Africa
Palma Demallorca, , Spain
Zhytomyr, , Ukraine
Swansea, , United Kingdom
Aalborg, , Denmark
Inglewood, California, United States
Sandanski, , Bulgaria
Toronto, Ontario, Canada
Amiens Cedex 1, , France
Ampang, , Malaysia
Ivano Frankivsk, , Ukraine
Rotenburg (Wümme), , Germany
Sarnia, Ontario, Canada
Praha 4, , Czechia
Slany, , Czechia
Dunaujvaros, , Hungary
Mechelen, , Belgium
Oradea, , Romania
Southampton, , United Kingdom
Marseille, , France
L'hospitalet De Llobregat, , Spain
Pamplona, , Spain
Ipoh, , Malaysia
Tarzana, California, United States
Xi'an, , China
Pisa, , Italy
Sendai Shi, , Japan
Bochum, , Germany
Cape Town, , South Africa
Seongnam Si, , Korea, Republic Of
New Bedford, Massachusetts, United States
Columbus, Ohio, United States
Manassas, Virginia, United States
Port Orange, Florida, United States
Eatontown, New Jersey, United States
Kinston, North Carolina, United States
Arlington, Texas, United States
Gwangju, , Korea, Republic Of
Lyon Cedex 03, , France
Rouen, , France
Strasbourg, , France
Genoa, , Italy
Fremont, California, United States
Honolulu, Hawaii, United States
Rocky Mount, North Carolina, United States
Cordoba, , Argentina
Mar Del Plata, , Argentina
San Nicolás, , Argentina
Santa Fe, , Argentina
Darlinghurst, , Australia
Wollongong, , Australia
Dupnitsa, , Bulgaria
Gotse Delchev, , Bulgaria
Kozloduy, , Bulgaria
Yambol, , Bulgaria
Nanchang, , China
Afula, , Israel
Saga Shi, , Japan
Yokohama Shi, , Japan
Kyiv, , Ukraine
Ho Chi Minh City, , Vietnam
Rosario, , Argentina
Changsha, , China
Tianjin, , China
Wuxi, , China
Limoges, , France
Beppu Shi, , Japan
Tsu Shi, , Japan
Gdynia, , Poland
Ho Chi Minh, , Vietnam
Karlsruhe, , Germany
Brandys Nad Labem, , Czechia
Kocaeli, , Turkey
Canterbury, , United Kingdom
Kfar Saba, , Israel
Zwolle, , Netherlands
Pordenone, , Italy
Gosford, , Australia
Jinan, , China
Shenzhen, , China
Taoyuan, , Taiwan
Győr, , Hungary
Kamakura Shi, , Japan
Fairhope, Alabama, United States
Sanford, North Carolina, United States
Curitiba, , Brazil
Porto Alegre, , Brazil
São Paulo, , Brazil
Lom, , Bulgaria
Waterloo, Ontario, Canada
Pingxiang, , China
Medellin, , Colombia
Kolding, , Denmark
Wonju Si, , Korea, Republic Of
D.F, , Mexico
Lima, , Peru
Davao City, , Philippines
Jasło, , Poland
Rzeszów, , Poland
Dammam, , Saudi Arabia
Uppsala, , Sweden
Hat Yai, , Thailand
Antalya, , Turkey
Hcmc, , Vietnam
Kayseri, , Turkey
Kansas City, Kansas, United States
Santiago Del Estero, , Argentina
Kitakyushu Shi, , Japan
Osaka Shi, , Japan
Cardiff, , United Kingdom
Boca Raton, Florida, United States
Southport, , Australia
Nyiregyhaza, , Hungary
Meguro Ku, , Japan
Sapporo Shi, , Japan
Piaseczno, , Poland
Napoli, , Italy
Singapore, , Singapore
Taipei City, , Taiwan
Hanoi, , Vietnam
Tradate, , Italy
Iwata Shi, , Japan
Kasugai Shi, , Japan
Nagaoka Shi, , Japan
Hai Phong, , Vietnam
Edgewater, Florida, United States
Pernik, , Bulgaria
Khon Kaen, , Thailand
Krnov, , Czechia
San Francisco, California, United States
Jacksonville, North Carolina, United States
Salt Lake City, Utah, United States
Winnipeg, Manitoba, Canada
Vijayawada, , India
Ansan Si, , Korea, Republic Of
Goyang Si, , Korea, Republic Of
Bellavista, , Peru
Tczew, , Poland
New Taipei, , Taiwan
Taichung, , Taiwan
St Leonards, , Australia
La Roche Sur Yon, , France
Haifa, , Israel
Szeged, , Hungary
San Fernando, , Philippines
Barranquilla, , Colombia
Nimes, , France
Berlin, , Germany
Ternopil, , Ukraine
Pearland, Texas, United States
Parow, , South Africa
Aarhus, , Denmark
Rostock, , Germany
Anyang Si, , Korea, Republic Of
Craiova, , Romania
Alexandroupolis, , Greece
St. John, New Brunswick, Canada
Kobe Shi, , Japan
Saint Joseph, Michigan, United States
Praha 10, , Czechia
Shanghai, , China
Sao Paulo, , Brazil
Iizuka Shi, , Japan
Osaka Shi, , Japan
Kashiwara Shi, , Japan
Riverdale, Georgia, United States
Lanzhou, , China
Linhai, , China
Bradford, , United Kingdom
Bad Homburg, , Germany
Hamburg, , Germany
Puchov, , Slovakia
Yantai, , China
Tiberias, , Israel
Itabashi Ku, , Japan
Alexandria, , Egypt
Brussel, , Belgium
Mueang, , Thailand
Córdoba, , Argentina
Arequipa, , Peru
Ningbo, , China
Oita Shi, , Japan
Benoni, , South Africa
Madurai, , India
Toyoake Shi, , Japan
Olomouc, , Czechia
Canoga Park, California, United States
Lewisville, Texas, United States
Byala, , Bulgaria
Praha, , Czechia
łódź, , Poland
Austin, Texas, United States
Uzhhorod, , Ukraine
Augusta, Georgia, United States
Toyohashi Shi, , Japan
Valdivia, , Chile
West Monroe, Louisiana, United States
Vinnytsya, , Ukraine
Zhengzhou City, , China
Humble, Texas, United States
Hengyang, , China
Shenzhen, , China
Campinas, , Brazil
Baotou, , China
Joinville, , Brazil
Amagasaki Shi, , Japan
Yaizu Shi, , Japan
Mazatlán, , Mexico
Chorrillos, , Peru
Hefei, , China
Białystok, , Poland
Lake City, Florida, United States
Surprise, Arizona, United States
Shantou, , China
Seremban, , Malaysia
Seri Manjung, , Malaysia
Nitra, , Slovakia
Chengdu, , China
Guangzhou, , China
Kanazawa Shi, , Japan
Yoshida Gun, , Japan
Boca Raton, Florida, United States
Zhuzhou, , China
Rio De Janeiro, , Brazil
Landshut, , Germany
Vinnytsia, , Ukraine
Nachod, , Czechia
Kraków, , Poland
Radom, , Poland
Adana, , Turkey
San Luis Potosí, , Mexico
Viña Del Mar, , Chile
Herne, , Germany
Karlsruhe, , Germany
Kurashiki Shi, , Japan
Bucuresti, , Romania
Omihachiman Shi, , Japan
Changzhou, , China
Cheonan Si, , Korea, Republic Of
Encs, , Hungary
Sao Jose Do Rio Preto, , Brazil
Bogota, , Colombia
Be'er Ya'akov, , Israel
Goettingen, , Germany
Yangsan Si, , Korea, Republic Of
Belem, , Brazil
Ashdod, , Israel
Kyoto Shi, , Japan
Morioka Shi, , Japan
Osaka, , Japan
Obihiro Shi, , Japan
Krakow, , Poland
Bristol, , United Kingdom
Lanus Este, , Argentina
Atlanta, Georgia, United States
Champaign, Illinois, United States
Tanabe Shi, , Japan
Piura, , Peru
Ruse, , Bulgaria
Conyers, Georgia, United States
Frýdek Místek, , Czechia
Woodbridge, Virginia, United States
Narita Shi, , Japan
Cuauhtemoc, , Mexico
Riverview, Florida, United States
Chester, Pennsylvania, United States
Naka, , Japan
Riyadh, , Saudi Arabia
Brandenburg An Der Havel, , Germany
Hengyang, , China
Jilemnice, , Czechia
Bassano Del Grappa, , Italy
Zapopan, , Mexico
Jiaxing, , China
Brasilia, , Brazil
Natal, , Brazil
Merida, , Mexico
Reinfeld (Holstein), , Germany
Caba, , Argentina
Cuauhtémoc, , Mexico
Shenyang, , China
Veracruz, , Mexico
Yung Kang City, , Taiwan
Kajang, , Malaysia
Almeria, , Spain
Brunswick, Georgia, United States
Jette, , Belgium
Sahinbey, , Turkey
Monteria, , Colombia
Newton, , South Africa
La Plata, , Argentina
Phutthamonthon, , Thailand
Hamamatsu Shi, , Japan
Matsusaka Shi, , Japan
Creteil, , France
Matsuyama City, , Japan
Panjin, , China
Potsdam, , Germany
Adapazarı, , Turkey
Huddinge, , Sweden
Pune, , India
Kolkata, , India
Petah Tikva, , Israel
Timisoara, , Romania
Montréal, Quebec, Canada
Cali, , Colombia
Campina Grande Do Sul, , Brazil
Midrand, , South Africa
Holbæk, , Denmark
Da Nang, , Vietnam
Kumagaya Shi, , Japan
Zigong, , China
Pierre Bénite, , France
Riyadh/Mena, , Saudi Arabia
Kahramanmaras, , Turkey
Heraclion, , Greece
Desio, , Italy
żywiec, , Poland
Myjava, , Slovakia
Danderyd, , Sweden
Chernivtsі, , Ukraine
Mladá Boleslav, , Czechia
Plzeň, , Czechia
Hakodate Shi, , Japan
Medellin, , Colombia
Hownslow, , United Kingdom
Saint Priest En Jarez, , France
Araucania, , Chile
Brest Cedex, , France
Kráľovský Chlmec, , Slovakia
Prešov, , Slovakia
Xianyang, , China
Kota Bharu, , Malaysia
New Britain, Connecticut, United States
Fortaleza, , Brazil
Copenhagen E, , Denmark
Marseille Cedex 6, , France
Laguna, , Philippines
Hyderabad, , India
Ankara, , Turkey
Dresden, , Germany
Bangalore, , India
Kitakyushu, , Japan
Cheras, , Malaysia
Altındağ, , Turkey
Banphaeo, , Thailand
Zhongshan, , China
Huaian, , China
Minokamo Shi, , Japan
Quimper, , France
Hilversum, , Netherlands
Jining, , China
Lanus, , Argentina
Temperley, , Argentina
Victoria, , Chile
Friedrichsthal, , Germany
Obertshausen, , Germany
Offenbach Am Main, , Germany
Zwenkau, , Germany
Lucknow, , India
Mumbai, , India
Higashihiroshima Shi, , Japan
Inashiki Gun, , Japan
Kuwana Shi, , Japan
Shibuya Ku, , Japan
Katowice, , Poland
Poznań, , Poland
Warszawa, , Poland
Wrocław, , Poland
świecie, , Poland
Brasov, , Romania
Bucharest, , Romania
Växjö, , Sweden
Haliliye, , Turkey
Izmit, , Turkey
Taichung City, , Taiwan
Ciudad De Buenos Aires, , Argentina
Surrey, British Columbia, Canada
Austell, Georgia, United States
Garden City, Michigan, United States
Ciudad Autonoma De Bs As, , Argentina
Edmonton, Alberta, Canada
Dongwan, , China
Pasto, , Colombia
Karlsburg, , Germany
New Delhi, , India
Bassano Del Grappa, , Italy
Aira City, , Japan
Chigasaki Shi, , Japan
Kagoshima, , Japan
Kita Ku, , Japan
Kuse Gun, , Japan
Miyakonojo Shi, , Japan
Ome, , Japan
Al Ahsa, , Saudi Arabia
Koshice, , Slovakia
Brandýs Nad Labem, , Czechia
Fujinomiya Shi, , Japan
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported