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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 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 324 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06350123
The ClinicalTrials.gov registry entry for NCT06350123 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 324 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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