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NCT06350123 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 324
- Enrollment target
NCT06350123: Completed Phase 2 study, sponsored by AstraZeneca.
NCT06350123 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 324 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (144% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06350123, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 324 participants
- Enrollment target
Study 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.
Primary Outcome
Evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on Urine Albumin-to-Creatinine Ratio (UACR).
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/dapa gliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 324 participants |
| Start Date | 2024-05-01 |
| Est. Completion | 2025-05-09 |
| Phase | Phase 2 |
What the finished NCT06350123 record still lists
NCT06350123 is an interventional study that assigns participants to a tested intervention. The registered 324 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (144% higher).
The record links to 0 conditions, and to 3 interventions - of which Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg is the first listed.
NCT06350123 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06350123 about?
NCT06350123 is a clinical study titled "Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease". 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-cre...
What is the current status of trial NCT06350123?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 324 participants. The study started on 2024-05-01. Estimated completion is 2025-05-09.
What interventions are being tested in trial NCT06350123?
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/dapa gliflozin (DRUG).
Who is sponsoring clinical trial NCT06350123?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06350123's enrollment target sits among peer trials
324 149th of 2000 higher than 1,851 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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