FINE-ONE: finerenone for CKD associated with T1D
What this study tests
Completed randomized phase-3 trial of finerenone versus placebo on top of standard care in adults with T1D and albuminuric chronic kidney disease. It met its six-month albuminuria endpoint, but did not test kidney failure or cardiovascular outcomes.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2025-10-21.
Most recent recorded citation date: 2026-03-04. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults with insulin-treated T1D, HbA1c below 10%, eGFR 25 to below 90 mL/min/1.73 m2, UACR 200 to below 5,000 mg/g, and potassium at or below 4.8 mmol/L. See registry for full criteria. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- The paper reports 242 randomized participants. UACR fell 34% with finerenone and 12% with placebo, a 25% greater reduction (ratio 0.75, 95% CI 0.65-0.87; P<0.001). Hyperkalemia occurred in 10.1% versus 3.3%, and 1.7% stopped finerenone because of it. This short surrogate-endpoint trial does not show fewer kidney failures, cardiovascular events, or deaths.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: United States, United Kingdom, European Union, Canada, Other regions. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Relative change in urinary albumin-to-creatinine ratio from baseline to six months
The full picture
This record has no longer discussion. Use the study criteria, reported results and original sources on this page to assess what is known and what remains unresolved.
Sources
- [1]Finerenone in Type 1 Diabetes and Chronic Kidney Disease · Peer-reviewed study · 2026-03-04 — Peer-reviewed phase-3 results. The publication reports 242 randomized participants and explicitly uses UACR change as the primary outcome.
- [2]NCT05901831: FINE-ONE · Trial registry · 2025-10-21 — COMPLETED; actual start 26 February 2024, primary completion 20 August 2025, study completion 15 September 2025. Registry actual enrollment is 241, one fewer than the paper's randomized count; no registry results are posted.