Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease
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Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
324actual
Sites
92
Countries
Austria, Brazil, Bulgaria +12
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-05-01 | actual | When the study began enrolling |
| Primary completion | 2025-05-09 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-05-09 | actual | The whole study's end, after follow-up |
| First posted | 2024-04-05 | actual | When this record first appeared on the registry |
| Results posted | 2026-06-26 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-06-26 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Chronic Kidney Disease
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
Primary outcome
what the primary-completion date above is the date OFRelative Change in Urine Albumin-to-Creatinine Ratio (UACR) From Baseline to Week 12
measured Baseline (Day 1) until Week 12 (Day 85)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-10-04 · 3.1 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-05-27 · 2.1 MB · SAP_001.pdf
Publications
- PMID 41218621 — linked by the registry
- PMID 40623005 — linked by the registry
- PMID 39962632 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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