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NCT06307652 · ClinicalTrials.gov registry record · Phase 3

Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

A Phase 3 study of Heart Failure and Impaired Kidney Function, sponsored by AstraZeneca.

Recruiting
Registry status
Phase 3
Development phase
4,800
Enrollment target
20
Study locations

NCT06307652: Recruiting Phase 3 study of Heart Failure and Impaired Kidney Function, sponsored by AstraZeneca.

NCT06307652 is a Phase 3 study of Heart Failure and Impaired Kidney Function that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 4,800 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (522% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06307652, a Phase 3 study of Heart Failure and Impaired Kidney Function, is actively recruiting participants, sponsored by AstraZeneca.

RECRUITING
Registry status
Phase 3
Development phase
4,800 participants
Enrollment target
20
Study locations

Study Summary

This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.

Primary Outcome

To determine whether balcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of CV death and HF events with and without hospitalisation

Conditions Studied

Heart Failure and Impaired Kidney Function

Interventions

  • DRUG balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
  • DRUG balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg
  • DRUG dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin

Study Locations (20)

California

  • Research Site - Beverly Hills
  • Research Site - Covina
  • Research Site - Encinitas
  • Research Site - Los Angeles
  • Research Site - Los Angeles
  • Research Site - Newport Beach
  • Research Site - Orange
  • Research Site - Redding
  • Research Site - San Diego
  • Research Site - San Francisco
  • Research Site - San Francisco
  • Research Site - Santa Ana
  • Research Site - Thousand Oaks

Alabama

  • Research Site - Alexander City
  • Research Site - Birmingham
  • Research Site - Fairhope
  • Research Site - Huntsville

Arizona

  • Research Site - Phoenix
  • Research Site - Phoenix

Arkansas

  • Research Site - Little Rock

Trial Details

FieldValue
Enrollment Target 4,800 participants
Start Date 2024-04-12
Est. Completion 2027-06-11
Phase Phase 3
AstraZeneca

1,285 total trials

What NCT06307652 shows while recruiting

NCT06307652 is an interventional study that assigns participants to a tested intervention. Its 4,800 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (522% higher).

The record links to 1 condition, with Heart Failure and Impaired Kidney Function appearing as the primary indexed condition, and to 3 interventions - of which balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg is the first listed.

NCT06307652 names 20 study sites across 4 states, led by California, Alabama, Arizona.

Frequently Asked Questions

What is clinical trial NCT06307652 about?

NCT06307652 is a clinical study titled "Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function". This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapag...

What is the current status of trial NCT06307652?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 4,800 participants. The study started on 2024-04-12. Estimated completion is 2027-06-11.

What conditions does trial NCT06307652 study?

This clinical trial studies the following conditions: Heart Failure and Impaired Kidney Function.

What interventions are being tested in trial NCT06307652?

The interventions under investigation include: balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg (DRUG), balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg (DRUG), dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin (DRUG).

Who is sponsoring clinical trial NCT06307652?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06307652 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT06307652's enrollment target sits among peer trials

4,800 53rd of 2000 higher than 1,948 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06307652

Source: ClinicalTrials.gov NCT06307652, the US trial registry maintained by the National Library of Medicine. NCT06307652 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.