CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 324 enrolled / 324 target
Drug / intervention
Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg +2 moredrug
Likely dose
Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06350123
NCT06350123Phase 2CompletedMonitor (12.4/mo)Completion was 13mo ago
CompareCT.gov

A Phase IIb, Multicenter, Randomised, Double-Blind, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of Balcinrenone in Combination With Dapagliflozin Compared With Dapagliflozin in Patients With Chronic Kidney Disease and Albuminuria

AstraZeneca·interventional·Posted Apr 5, 2024·Updated Jun 26, 2026

In Brief

A Phase 2 clinical trial evaluating 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, and 1 other intervention for Chronic Kidney Disease. Completed, enrolled 324 participants across 92 sites in 15 countries.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease
CountriesAustria, Brazil, Bulgaria, Canada, China, Italy, Japan, Malaysia, Poland, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States, Vietnam
Collaborators--

Timeline

Phase 2CompletedFinished
20252026
First PostedApr 5, 2024
Enrollment StartMay 1, 2024
Primary CompletionMay 9, 2025
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 2.2 years ago

Arms & Interventions

Balcinrenone/dapagliflozin 15 mg/10 mgexperimental

Patients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin

Drug: Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
Balcinrenone/dapagliflozin 40 mg/10 mgexperimental

Patients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin

Drug: Balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg
Dapagliflozin 10 mgactive_comparator

Patients will be randomized 1:1:1 to either balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin

Drug: Dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin

Interventions

Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mgdrug

1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use

Balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mgdrug

1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use

Dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozindrug

1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use