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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
2026-06-03
Healthy Volunteers
No
Conditions
Interventions
Balcinrenone/dapagliflozin
balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
Dapagliflozin
dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin
Locations (45)
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Ciudad de Buenos Aires, Argentina
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Edmonton, Alberta, Canada
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Winnipeg, Manitoba, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
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Halifax, Canada
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Magdeburg, Germany
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Kita-ku, Japan
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Osaka, Japan
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Olsztyn, Poland
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Warsaw, Poland
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Warsaw, Poland
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Węgrów, Poland
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Wroclaw, Poland
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Żywiec, Poland
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Anyang, South Korea
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Cheonan-si, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Changhua, Taiwan
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Hualien City, Taiwan
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Kaohsiung City, Taiwan
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Kaohsiung City, Taiwan
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New Taipei City, Taiwan
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Taichung, Taiwan
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Taichung, Taiwan
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Taichung, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taoyuan, Taiwan
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Zhubei, Taiwan
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Da Nang, Vietnam
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Hanoi, Vietnam
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Hanoi, Vietnam
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Hà Nội, Vietnam
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Ho Chi Minh City, Vietnam
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Hochiminh City, Vietnam