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

NCT07624305 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2800

Last updated 2026-06-03

No results posted yet for this study

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.

Conditions

  • Renal Insufficiency, Chronic

Interventions

DRUG

Dapagliflozin

dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin

DRUG

Balcinrenone/dapagliflozin

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2030-07-01
Completion
2030-07-01
FDA Drug
Yes

Countries

  • Argentina
  • Canada
  • Germany
  • Japan
  • Poland
  • South Korea
  • Taiwan
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07624305 on ClinicalTrials.gov