RECRUITING Phase 3 ClinicalTrials.gov

A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)

Sponsor: AstraZeneca • ClinicalTrials.gov ID: NCT07624305

Registry updated: 2026-09-24

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Description

The purpose of this study is to evaluate the efficacy, safety and tolerability of balcinrenone in fixed combination with dapagliflozin, compared with dapagliflozin, in patients with CKD Stage 3b and 4 (eGFR ≥ 15 to \< 45 mL/min/1.73 m2) administered orally once daily in addition to SoC. This is a population with high unmet medical need and an increased risk of CKD progression, who are frequently excluded from interventional trials.

Interventions

Balcinrenone/dapagliflozin (Drug)
balcinrenone/dapagliflozin 15 mg/10 mg
Dapagliflozin (Drug)
dapagliflozin 10 mg
Placebo matching Dapagliflozin (Drug)
matching placebo for dapagliflozin 10 mg
Placebo matching balcinrenone/dapagliflozin (Drug)
matching placebo for balcinrenone/dapagliflozin

Eligibility criteria

Inclusion Criteria: * Age ≥ 18 years * Diagnosis of CKD and at least one of the following: 1. eGFR ≥ 15 to \< 45 mL/min/1.73 m2 AND: UACR ≥ 30 mg/g (central laboratory) or UACR ≥ 100 mg/g (local laboratory ) or UPCR ≥ 200 mg/g (local laboratory). 2. eGFR ≥ 15 to \< 30 mL/min/1.73 m2 and UACR \< 30 mg/g (local or central laboratory UACR value). * Serum/plasma K+ ≤ 5.0 mmol/L * Maximum tolerated dose of an ACEi or an ARB, unless contraindicated or not tolerated. The dose should be stable for at least 4 weeks before screening. Exclusion Criteria: * Recent (within 90 days prior to screening) or ongoing dialysis, or likely to require dialysis within 3 months following randomisation * UACR ≥ 5000 mg/g or UPCR ≥ 7000 mg/g at screening. * SBP \> 180 mmHg or DBP \> 110 mmHg at screening. * SBP \< 90 mmHg at screening. * HbA1c \> 9% at screening * T1DM, except: 1. For US only: patients with T1DM treated with SGLT2i for at least 4 months prior to screening, without DKA during that period, and who have experience with ketone monitoring are eligible. 2. For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months prior to Screening, without DKA during the period of dapagliflozin treatment are eligible for inclusion. * Autosomal dominant polycystic kidney disease. * Major cardiac or valvular surgery, acute coronary syndrome (myocardial infarction or unstable angina), stroke, transient ischaemic attack within 12 weeks prior to screening. * Severe hepatic impairment (Child-Pugh Class C). * Adrenal insufficiency. * Clinically significant acute kidney injury within 12 weeks prior to the screening. * New York Heart Association functional HF class IV at screening, or hospitalisation for heart failure within 4 weeks prior to screening. * Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months) prior to screening. * Solid organ or bone marrow transplant or a plan for transplant within 6 months following randomisation. * Any use of the following medications and supplements: 1. MRAs 2. Aldosterone analogues 3. Aldosterone synthase inhibitors 4. Any use of potassium binders within 2 weeks prior to screening. Use is allowed after randomisation. 5. Strong or moderate inducers or inhibitors of CYP3A4, prohibited at least one week prior to randomisation

Conditions

Renal Insufficiency, Chronic

Locations

Research Site — Huntsville, Alabama, United States
Research Site — Surprise, Arizona, United States
Research Site — Tempe, Arizona, United States
Research Site — Little Rock, Arkansas, United States
Research Site — Concord, California, United States
Research Site — Daly City, California, United States
Research Site — Fremont, California, United States
Research Site — Huntington Park, California, United States
Research Site — Lancaster, California, United States
Research Site — Lynwood, California, United States
Research Site — Northridge, California, United States
Research Site — Palo Alto, California, United States
Research Site — Pomona, California, United States
Research Site — Riverside, California, United States
Research Site — San Dimas, California, United States
Research Site — Tarzana, California, United States
Research Site — Washington D.C., District of Columbia, United States
Research Site — Boca Raton, Florida, United States
Research Site — Fort Lauderdale, Florida, United States
Research Site — Gainesville, Florida, United States
Research Site — Hollywood, Florida, United States
Research Site — Jacksonville Beach, Florida, United States
Research Site — Lakeland, Florida, United States
Research Site — Melbourne, Florida, United States
Research Site — Orlando, Florida, United States
Research Site — Port Charlotte, Florida, United States
Research Site — Riverview, Florida, United States
Research Site — Weston, Florida, United States
Research Site — Brunswick, Georgia, United States
Research Site — East Point, Georgia, United States
Research Site — Macon, Georgia, United States
Research Site — Savannah, Georgia, United States
Research Site — Oak Brook, Illinois, United States
Research Site — Rockford, Illinois, United States
Research Site — Iowa City, Iowa, United States
Research Site — Wichita, Kansas, United States
Research Site — Louisville, Kentucky, United States
Research Site — Ann Arbor, Michigan, United States
Research Site — Saint Joseph, Michigan, United States
Research Site — Mankato, Minnesota, United States
Research Site — Kansas City, Missouri, United States
Research Site — Albuquerque, New Mexico, United States
Research Site — Albany, New York, United States
Research Site — Long Island City, New York, United States
Research Site — The Bronx, New York, United States
Research Site — Asheville, North Carolina, United States
Research Site — Charlotte, North Carolina, United States
Research Site — Cincinnati, Ohio, United States
Research Site — Cincinnati, Ohio, United States
Research Site — Media, Pennsylvania, United States
Research Site — Columbia, South Carolina, United States
Research Site — Greenville, South Carolina, United States
Research Site — Chattanooga, Tennessee, United States
Research Site — Fort Worth, Texas, United States
Research Site — Houston, Texas, United States
Research Site — Irving, Texas, United States
Research Site — Lufkin, Texas, United States
Research Site — McKinney, Texas, United States
Research Site — Pasadena, Texas, United States
Research Site — San Antonio, Texas, United States
Research Site — San Antonio, Texas, United States
Research Site — Sherman, Texas, United States
Research Site — Stephenville, Texas, United States
Research Site — Sugar Land, Texas, United States
Research Site — Sugar Land, Texas, United States
Research Site — Arlington, Virginia, United States
Research Site — Richmond, Virginia, United States
Research Site — Salem, Virginia, United States
Research Site — Woodbridge, Virginia, United States
Research Site — CABA, Argentina
Research Site — Capital Federal, Argentina
Research Site — Ciudad de Buenos Aires, Argentina
Research Site — La Plata, Argentina
Research Site — Lanús Este, Argentina
Research Site — Mar del Plata, Argentina
Research Site — Rosario, Argentina
Research Site — Rosario, Argentina
Research Site — Rosario, Argentina
Research Site — San Nicolás, Argentina
Research Site — Santa Fe, Argentina
Research Site — Santa Fe, Argentina
Research Site — Feldkirch, Austria
Research Site — Innsbruck, Austria
Research Site — Linz, Austria
Research Site — Sankt Pölten, Austria
Research Site — Vienna, Austria
Research Site — Vienna, Austria
Research Site — Vienna, Austria
Research Site — Vienna, Austria
Research Site — Wels, Austria
Research Site — Wiener Neustadt, Austria
Research Site — Barretos, Brazil
Research Site — Belém, Brazil
Research Site — Belo Horizonte, Brazil
Research Site — Belo Horizonte, Brazil
Research Site — Campinas, Brazil
Research Site — Goiânia, Brazil
Research Site — Natal, Brazil
Research Site — Recife, Brazil
Research Site — São Caetano do Sul, Brazil
Research Site — São José do Rio Preto, Brazil
Research Site — São José dos Campos, Brazil
Research Site — São Paulo, Brazil
Research Site — São Paulo, Brazil
Research Site — São Paulo, Brazil
Research Site — São Paulo, Brazil
Research Site — Blagoevgrad, Bulgaria
Research Site — Nova Zagora, Bulgaria
Research Site — Pleven, Bulgaria
Research Site — Plovdiv, Bulgaria
Research Site — Sandanski, Bulgaria
Research Site — Sevlievo, Bulgaria
Research Site — Sofia, Bulgaria
Research Site — Sofia, Bulgaria
Research Site — Sofia, Bulgaria
Research Site — Stara Zagora, Bulgaria
Research Site — Varna, Bulgaria
Research Site — Calgary, Alberta, Canada
Research Site — Edmonton, Alberta, Canada
Research Site — Winnipeg, Manitoba, Canada
Research Site — Halifax, Nova Scotia, Canada
Research Site — Brampton, Ontario, Canada
Research Site — Greater Sudbury, Ontario, Canada
Research Site — London, Ontario, Canada
Research Site — Mississauga, Ontario, Canada
Research Site — Oakville, Ontario, Canada
Research Site — Toronto, Ontario, Canada
Research Site — Toronto, Ontario, Canada
Research Site — Waterloo, Ontario, Canada
Research Site — Montreal, Quebec, Canada
Research Site — Montreal, Quebec, Canada
Research Site — Montreal, Quebec, Canada
Research Site — Montreal, Quebec, Canada
Research Site — Québec, Quebec, Canada
Research Site — Baotou, China
Research Site — Beijing, China
Research Site — Beijing, China
Research Site — Beijing, China
Research Site — Beijing, China
Research Site — Changchun, China
Research Site — Changsha, China
Research Site — Changzhou, China
Research Site — Changzhou, China
Research Site — Chengdu, China
Research Site — Chengdu, China
Research Site — Chongqing, China
Research Site — Dongguan, China
Research Site — Dongyang, China
Research Site — Ganzhou, China
Research Site — Guangzhou, China
Research Site — Guangzhou, China
Research Site — Guiyang, China
Research Site — Hebei, China
Research Site — Hohhot, China
Research Site — Huaian, China
Research Site — Jinan, China
Research Site — Jining, China
Research Site — Jiujiang, China
Research Site — Linhai, China
Research Site — Nanchang, China
Research Site — Nanjing, China
Research Site — Nanjing, China
Research Site — Nanning, China
Research Site — Nanning, China
Research Site — Ningbo, China
Research Site — Ningbo, China
Research Site — Ningbo, China
Research Site — Ningbo, China
Research Site — Panjin, China
Research Site — Pingxiang, China
Research Site — Qingzhou, China
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Shantou, China
Research Site — Shenyang, China
Research Site — Shenzhen, China
Research Site — Shenzhen, China
Research Site — Suzhou, China
Research Site — Ürümqi, China
Research Site — Wuhan, China
Research Site — Wuhan, China
Research Site — Wuxi, China
Research Site — Xiamen, China
Research Site — Xiamen, China
Research Site — Xuzhou, China
Research Site — Yancheng, China
Research Site — Yangzhou, China
Research Site — Yangzhou, China
Research Site — Yantai, China
Research Site — Yibin, China
Research Site — Yinchuan, China
Research Site — Zhenjiang, China
Research Site — Zhuzhou, China
Research Site — Boulogne-sur-Mer, France
Research Site — Caen, France
Research Site — Cherbourg, France
Research Site — Colmar, France
Research Site — La Roche-sur-Yon, France
Research Site — Le Mans, France
Research Site — Marseille, France
Research Site — Nîmes, France
Research Site — Orléans, France
Research Site — Rouen, France
Research Site — Saint-Priez En Jarez, France
Research Site — Toulouse, France
Research Site — Tours, France
Research Site — Aachen, Germany
Research Site — Bad Nenndorf, Germany
Research Site — Berlin, Germany
Research Site — Berlin, Germany
Research Site — Berlin, Germany
Research Site — Bonn, Germany
Research Site — Brandenburg an der Havel, Germany
Research Site — Braunschweig, Germany
Research Site — Cloppenburg, Germany
Research Site — Essen, Germany
Research Site — Frankfurt am Main, Germany
Research Site — Fulda, Germany
Research Site — Gladbeck, Germany
Research Site — Goslar, Germany
Research Site — Hanover, Germany
Research Site — Heidelberg, Germany
Research Site — Leipzig, Germany
Research Site — Magdeburg, Germany
Research Site — München, Germany
Research Site — München, Germany
Research Site — Münster, Germany
Research Site — Nuremberg, Germany
Research Site — Nuremberg, Germany
Research Site — Obertshausen, Germany
Research Site — Riesa, Germany
Research Site — Rostock, Germany
Research Site — Rotenburg (Wümme), Germany
Research Site — Villingen-Schwenningen, Germany
Research Site — Würzburg, Germany
Research Site — Athens, Greece
Research Site — Athens, Greece
Research Site — Athens, Greece
Research Site — Heraklion, Greece
Research Site — Heraklion, Greece
Research Site — Ioannina, Greece
Research Site — Larissa, Greece
Research Site — Marousi, Greece
Research Site — Piraeus, Greece
Research Site — Rio, Greece
Research Site — Thessaloniki, Greece
Research Site — Aligarh, India
Research Site — Belagavi, India
Research Site — Bhubaneswar, India
Research Site — Calicut, India
Research Site — Coimbatore, India
Research Site — Dehli, India
Research Site — Dehradun, India
Research Site — Hyderabad, India
Research Site — Jaipur, India
Research Site — Jodhpur, India
Research Site — Kanpur, India
Research Site — Kochi, India
Research Site — Kolkata, India
Research Site — Mumbai, India
Research Site — Mumbai, India
Research Site — Mysore, India
Research Site — Nagpur, India
Research Site — New Delhi, India
Research Site — New Delhi, India
Research Site — New Delhi, India
Research Site — Pune, India
Research Site — Thiruvananthapuram, India
Research Site — Vijayawada, India
Research Site — Bari, Italy
Research Site — Bologna, Italy
Research Site — Cosenza, Italy
Research Site — Cremona, Italy
Research Site — Genoa, Italy
Research Site — Milan, Italy
Research Site — Modena, Italy
Research Site — Naples, Italy
Research Site — Palermo, Italy
Research Site — Pavia, Italy
Research Site — Ranica, Italy
Research Site — Verona, Italy
Research Site — Ageo, Japan
Research Site — Asahi-shi, Japan
Research Site — Chiba, Japan
Research Site — Fukaya, Japan
Research Site — Fukui-shi, Japan
Research Site — Izumisano, Japan
Research Site — Izunokuni-shi, Japan
Research Site — Kariya, Japan
Research Site — Kisarazu-shi, Japan
Research Site — Kita-ku, Japan
Research Site — Kitakyusyu-shi, Japan
Research Site — Kofu, Japan
Research Site — Koga-shi, Japan
Research Site — Komatsu-shi, Japan
Research Site — Koshigaya-shi, Japan
Research Site — Kumagaya-shi, Japan
Research Site — Kumamoto, Japan
Research Site — Kurashiki Shi, Japan
Research Site — Kuwana-shi, Japan
Research Site — Kyoto, Japan
Research Site — Kyoto, Japan
Research Site — Matsumoto-shi, Japan
Research Site — Minamiuonuma, Japan
Research Site — Minatoku, Japan
Research Site — Minokamo Shi, Japan
Research Site — Morioka, Japan
Research Site — Nagoya, Japan
Research Site — Nagoya, Japan
Research Site — Naka, Japan
Research Site — Nerima-ku, Japan
Research Site — Osaka, Japan
Research Site — Osaka, Japan
Research Site — Sendai, Japan
Research Site — Takatsuki-shi, Japan
Research Site — Toride-shi, Japan
Research Site — Tsu, Japan
Research Site — Urayasu, Japan
Research Site — Yokohama, Japan
Research Site — Cheras, Malaysia
Research Site — Ipoh, Malaysia
Research Site — Kajang, Malaysia
Research Site — Kota Kinabalu, Malaysia
Research Site — Kuala Lumpur, Malaysia
Research Site — Kuala Lumpur, Malaysia
Research Site — Kuantan, Malaysia
Research Site — Muar town, Malaysia
Research Site — Sarawak Miri, Malaysia
Research Site — Sungai Buloh, Malaysia
Research Site — Benito Juárez, Mexico
Research Site — Culiacán, Mexico
Research Site — Culiacán, Mexico
Research Site — Durango, Mexico
Research Site — Ecatepec de Morelos, Mexico
Research Site — Estado de México, Mexico
Research Site — Mexico City, Mexico
Research Site — México, Mexico
Research Site — Tuxpan, Mexico
Research Site — Veracruz, Mexico
Research Site — Villahermosa, Mexico
Research Site — Xalapa, Mexico
Research Site — Callao, Peru
Research Site — Chorrillos, Peru
Research Site — Cusco, Peru
Research Site — Lima, Peru
Research Site — Lima, Peru
Research Site — Lima, Peru
Research Site — Lima, Peru
Research Site — Lima, Peru
Research Site — Lima, Peru
Research Site — Lima, Peru
Research Site — Piura, Peru
Research Site — Trujillo, Peru
Research Site — Dasmariñas, Philippines
Research Site — Davao DEL SUR, Philippines
Research Site — Iloilo City, Philippines
Research Site — Las Piñas, Philippines
Research Site — Manila, Philippines
Research Site — Quezon City, Philippines
Research Site — Quezon City, Philippines
Research Site — West San Juan City, Philippines
Research Site — Olsztyn, Poland
Research Site — Warsaw, Poland
Research Site — Warsaw, Poland
Research Site — Węgrów, Poland
Research Site — Wroclaw, Poland
Research Site — Żywiec, Poland
Research Site — Brasov, Romania
Research Site — Bucharest, Romania
Research Site — Bucharest, Romania
Research Site — Bucharest, Romania
Research Site — Craiova, Romania
Research Site — Galati, Romania
Research Site — Oradea, Romania
Research Site — Timișoara, Romania
Research Site — Anyang, South Korea
Research Site — Cheonan-si, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Wŏnju, South Korea
Research Site — Yangsan, South Korea
Research Site — Badajoz, Spain
Research Site — Barcelona, Spain
Research Site — Barcelona, Spain
Research Site — Barcelona, Spain
Research Site — Córdoba, Spain
Research Site — Girona, Spain
Research Site — Madrid, Spain
Research Site — Madrid, Spain
Research Site — Majadahonda, Spain
Research Site — Talavera de la Reina, Spain
Research Site — Valencia, Spain
Research Site — Valencia, Spain
Research Site — Changhua, Taiwan
Research Site — Hualien City, Taiwan
Research Site — Kaohsiung City, Taiwan
Research Site — Kaohsiung City, Taiwan
Research Site — New Taipei City, Taiwan
Research Site — Taichung, Taiwan
Research Site — Taichung, Taiwan
Research Site — Taichung, Taiwan
Research Site — Taichung, Taiwan
Research Site — Tainan, Taiwan
Research Site — Tainan, Taiwan
Research Site — Taipei, Taiwan
Research Site — Taipei, Taiwan
Research Site — Taipei, Taiwan
Research Site — Taoyuan, Taiwan
Research Site — Zhubei, Taiwan
Research Site — Bangkok, Thailand
Research Site — Bangkok, Thailand
Research Site — Bangkok, Thailand
Research Site — Bangkok, Thailand
Research Site — Banphaeo, Thailand
Research Site — Changwat Sara Buri, Thailand
Research Site — Chiang Mai, Thailand
Research Site — Hat Yai, Thailand
Research Site — Naimuang, Thailand
Research Site — Phitsanulok, Thailand
Research Site — Ubonratchathani, Thailand
Research Site — Adapazarı, Turkey (Türkiye)
Research Site — Ankara, Turkey (Türkiye)
Research Site — Antalya, Turkey (Türkiye)
Research Site — Dinar, Turkey (Türkiye)
Research Site — İzmit, Turkey (Türkiye)
Research Site — Kahramanmaraş, Turkey (Türkiye)
Research Site — Kayseri, Turkey (Türkiye)
Research Site — Kazımkarabekir, Turkey (Türkiye)
Research Site — Malatya, Turkey (Türkiye)
Research Site — Samsun, Turkey (Türkiye)
Research Site — Ivano-Frankivsk, Ukraine
Research Site — Kyiv, Ukraine
Research Site — Kyiv, Ukraine
Research Site — Kyiv, Ukraine
Research Site — Kyiv, Ukraine
Research Site — Kyiv, Ukraine
Research Site — Kyiv, Ukraine
Research Site — Kyiv, Ukraine
Research Site — Kyiv, Ukraine
Research Site — Lviv, Ukraine
Research Site — Vinnytsia, Ukraine
Research Site — Vinnytsia, Ukraine
Research Site — Vinnytsia, Ukraine
Research Site — Aberdeen, United Kingdom
Research Site — Bristol, United Kingdom
Research Site — Cardiff, United Kingdom
Research Site — Dundee, United Kingdom
Research Site — Glasgow, United Kingdom
Research Site — London, United Kingdom
Research Site — London, United Kingdom
Research Site — London, United Kingdom
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Research Site — Swansea, United Kingdom
Research Site — Can Tho, Vietnam
Research Site — Da Nang, Vietnam
Research Site — Da Nang, Vietnam
Research Site — Hanoi, Vietnam
Research Site — Hanoi, Vietnam
Research Site — Hà Nội, Vietnam
Research Site — Ho Chi Minh City, Vietnam
Research Site — Ho Chi Minh City, Vietnam
Research Site — Hochiminh City, Vietnam
Research Site — Hochiminh, Vietnam
Research Site — Huế, Vietnam

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