BENITIONSClinical Trial Intelligence

Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease

Фаза 2 Завершено NCT06350123

ЗаболеваниеChronic Kidney Disease
ФазаФаза 2
СпонсорAstraZeneca
СтатусЗавершено
Участники324 участн.
ВмешательствоBalcinrenone/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
Дата начала1.05.2024
Дата завершения9.05.2025
Публикация результатов26.06.2026

Кратко

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 mg0.76 mg/g
Balcinrenone/Dapagliflozin 40 mg/10 mg0.66 mg/g
Dapagliflozin 10 mg0.98 mg/g
p-value<0.001
Percent change difference-32.77 (95% CI -41.96–-22.14)

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