Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07624305 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from AstraZeneca

Record History

  1. Primary endpoint(s) modified Recruitment opened · Trial sites expanded: 45 → 478 locations · Interventions modified · 3 more Show 6 more changesShow less
    • Recruitment opened
    • Trial sites expanded: 45 → 478 locations
    • Interventions modified
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints revised (5)
    • Study description expanded, about 2 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07624305
Lead Sponsor AstraZeneca
Conditions Renal Insufficiency, Chronic
Enrollment 2,800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov