Pure Global
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
AstraZeneca·Phase 2·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Chronic Kidney Disease
Drug/Device/Intervention
Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
AstraZeneca
Location
Sheffield,Glendale,San Carlos,Waterbury,Hialeah,Miami Lakes,Annapolis,El Paso,Houston,Houston,San Antonio,Ogden,Salt Lake City,Salt Lake City,Norfolk,Linz,St. Pölten,Vienna,Wels,Wien,Wien,Wien,Sao Pau, Austria,Brazil,Bulgaria,Canada,Chile,China,Italy,Japan,Malaysia,Poland,Spain,Taiwan,United Kingdom,U
Timeline & enrollment
Phase
Phase 2
Start date
May 01, 2024
End date
Jan 13, 2026
Enrollment
300 participants
Primary outcome

Relative change in UACR from baseline to Week 12

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.

ICD-10 classifications
Chronic kidney diseaseChronic kidney disease, unspecifiedChronic kidney disease, stage 1Chronic kidney disease, stage 4Chronic kidney disease, stage 2
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06350123
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06350123 through Pure Global AI's free database. This Phase 2 trial is sponsored by AstraZeneca and is currently Recruiting. The study focuses on Chronic Kidney Disease. Target enrollment is 300 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.