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A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)
Sponsor: AstraZeneca
Summary
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.
Official title: A Phase III, Randomised, Double-blind, Study to Evaluate the Effect of Balcinrenone/Dapagliflozin Compared With Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Chronic Kidney Disease (Stage 3b and 4)
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
2800
Start Date
2026-09-01
Completion Date
2030-07-01
Last Updated
2026-09-24
Healthy Volunteers
No
Conditions
Interventions
Balcinrenone/dapagliflozin
balcinrenone/dapagliflozin 15 mg/10 mg
Dapagliflozin
dapagliflozin 10 mg
Placebo matching Dapagliflozin
matching placebo for dapagliflozin 10 mg
Placebo matching balcinrenone/dapagliflozin
matching placebo for balcinrenone/dapagliflozin
Locations (478)
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Huntsville, Alabama, United States
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Surprise, Arizona, United States
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Tempe, Arizona, United States
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Little Rock, Arkansas, United States
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Concord, California, United States
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Daly City, California, United States
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Fremont, California, United States
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Huntington Park, California, United States
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Lancaster, California, United States
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Lynwood, California, United States
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Northridge, California, United States
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Palo Alto, California, United States
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Pomona, California, United States
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Riverside, California, United States
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San Dimas, California, United States
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Tarzana, California, United States
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Washington D.C., District of Columbia, United States
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Boca Raton, Florida, United States
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Fort Lauderdale, Florida, United States
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Gainesville, Florida, United States
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Hollywood, Florida, United States
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Jacksonville Beach, Florida, United States
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Lakeland, Florida, United States
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Melbourne, Florida, United States
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Orlando, Florida, United States
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Port Charlotte, Florida, United States
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Riverview, Florida, United States
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Weston, Florida, United States
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Brunswick, Georgia, United States
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East Point, Georgia, United States
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Macon, Georgia, United States
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Savannah, Georgia, United States
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Oak Brook, Illinois, United States
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Rockford, Illinois, United States
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Iowa City, Iowa, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Ann Arbor, Michigan, United States
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Saint Joseph, Michigan, United States
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Mankato, Minnesota, United States
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Kansas City, Missouri, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Long Island City, New York, United States
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The Bronx, New York, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Media, Pennsylvania, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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Chattanooga, Tennessee, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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Lufkin, Texas, United States
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McKinney, Texas, United States
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Pasadena, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Sherman, Texas, United States
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Stephenville, Texas, United States
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Sugar Land, Texas, United States
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Sugar Land, Texas, United States
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Arlington, Virginia, United States
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Richmond, Virginia, United States
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Salem, Virginia, United States
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Woodbridge, Virginia, United States
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CABA, Argentina
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Capital Federal, Argentina
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Ciudad de Buenos Aires, Argentina
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La Plata, Argentina
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Lanús Este, Argentina
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Mar del Plata, Argentina
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Rosario, Argentina
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Rosario, Argentina
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Rosario, Argentina
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San Nicolás, Argentina
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Santa Fe, Argentina
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Santa Fe, Argentina
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Feldkirch, Austria
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Innsbruck, Austria
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Linz, Austria
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Sankt Pölten, Austria
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Vienna, Austria
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Vienna, Austria
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Vienna, Austria
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Vienna, Austria
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Wels, Austria
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Wiener Neustadt, Austria
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Barretos, Brazil
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Belém, Brazil
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Belo Horizonte, Brazil
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Belo Horizonte, Brazil
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Campinas, Brazil
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Goiânia, Brazil
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Natal, Brazil
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Recife, Brazil
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São Caetano do Sul, Brazil