Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults with Chronic Kidney Disease - MIRO-CKD

Study identifier:D6405C00002

ClinicalTrials.gov identifier:NCT06350123

EudraCT identifier:N/A

CTIS identifier:2023-509709-63-00

Recruiting

Official Title

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

Medical condition

Chronic Kidney Disease

Phase

Phase 2

Healthy volunteers

No

Study drug

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

Sex

All

Estimated Enrollment

300

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 01 May 2024
Estimated Primary Completion Date: 13 Jan 2026
Estimated Study Completion Date: 13 Jan 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria