A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of balcinrenone in fixed combination with dapagliflozin, compared with dapagliflozin, in patients with CKD Stage 3b and 4 (eGFR ≥ 15 to < 45 mL/min/1.73 m2) administered orally once daily in addition to SoC. This is a population with high unmet medical need and an increased risk of CKD progression, who are frequently excluded from interventional trials.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Renal Insufficiency, Chronic

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

18 to 99 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

AstraZeneca

Last updated on ClinicalTrials.gov

September 24, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites