NCT06350123

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 324 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase IIb, multicentre, randomised, double-blind, dose-finding, parallel group, double-dummy study aiming to determine the effect on albuminuria, as well as safety and tolerability, of balcinrenone/dapagliflozin compared with dapagliflozin, when given once daily on top of other Standard of Care (SoC) to patients with CKD and albuminuria. Study population will include participants with CKD (eGFR ≥ 25 to \< 60 mL/min/1.73 m2) and UACR \> 100 mg/g to ≤ 5000 mg/g. Participants with or without a diagnosis of T2DM and with or without an SGLT2 inhibitor treatment at screening are eligible for the study. The study will be conducted at approximately 110 sites in approximately 16 countries globally. At least 300 participants will be randomised in order to have 300 evaluable participants. Participants will be randomised to one of 3 treatment arms in a 1:1:1 ratio: * Balcinrenone/dapagliflozin 15 mg/10 mg * Balcinrenone/dapagliflozin 40 mg/10 mg * Dapagliflozin 10 mg For each participant, the total duration of participation will be approximately 23 weeks: an up to 3-week screening period followed by a 12-week treatment period, and an 8-week follow-up period after end of investigational medicinal product (IMP) treatment.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg	1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
DRUG	Balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg	1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
DRUG	Dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin	1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-05-09
• Completion: 2025-05-09
• First posted: 2024-04-05
• Last updated: 2025-05-16

Locations

93 sites across 15 countries: United States, Austria, Brazil, Bulgaria, Canada, China, Italy, Japan, Malaysia, Poland, Spain, Taiwan, Turkey (Türkiye), United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study