Pure Global

Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease. - Trial NCT06350123

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.

Free Database
Powered by Pure Global AI
840K+ Trials
NCT06350123
Phase 2
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06350123
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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

Study Focus

Chronic Kidney Disease

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

Interventional

drug

Sponsor & Location

AstraZeneca

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. Pรถlten,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 2

May 01, 2024

Jan 13, 2026

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 disease
Chronic kidney disease, unspecified
Chronic kidney disease, stage 1
Chronic kidney disease, stage 4
Chronic kidney disease, stage 2

Data Source

ClinicalTrials.gov

NCT06350123

Non-Device Trial