Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease
Phase 2
Completed
NCT06350123
| Condition | Chronic Kidney Disease |
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| Phase | Phase 2 |
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| Sponsor | AstraZeneca |
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| Status | Completed |
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| Enrollment | 324 participants |
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| Interventions | Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg, Balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg, Dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin |
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| Start date | May 1, 2024 |
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| Completion date | May 9, 2025 |
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| Results posted | Jun 26, 2026 |
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Summary
The purpose of the study is to evaluate the efficacy, safety and tolerability of balcinrenone/dapagliflozin compared with dapagliflozin alone on patients with chronic kidney disease (CKD) and albuminuria. This study will evaluate the effect of the balcinrenone/dapagliflozin on urinary albumin-to-creatinine ratio (UACR), compared with dapagliflozin in patients with CKD. This is a dose-finding study aiming to identify an optimal dose of balcinrenone/dapagliflozin for a future Phase III study in patients with CKD.
Relative Change in Urine Albumin-to-Creatinine Ratio (UACR) From Baseline to Week 12
Baseline (Day 1) until Week 12 (Day 85) · mg/g
| Balcinrenone/Dapagliflozin 15 mg/10 mg | 0.76 mg/g |
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| Balcinrenone/Dapagliflozin 40 mg/10 mg | 0.66 mg/g |
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| Dapagliflozin 10 mg | 0.98 mg/g |
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| p-value | <0.001 |
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| Percent change difference | -32.77 (95% CI -41.96–-22.14) |
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Open in BENITIONS
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