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NOT YET RECRUITING
NCT07624305
PHASE3

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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

Interventions

DRUG

Balcinrenone/dapagliflozin

balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg

DRUG

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