New data from the Phase III FINE-ONE trial show that finerenone, a nonsteroidal mineralocorticoid receptor antagonist, significantly reduced urine albumin-to-creatinine ratio (UACR) over six months in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). The results were presented during the opening plenary session at the American Society of Nephrology (ASN) Kidney Week 2025.
The trial met its primary endpoint, with patients receiving finerenone alongside standard care experiencing a 25% reduction in UACR compared to placebo (95% CI=0.75 [0.65–0.87]; p=0.0001). UACR is an established biomarker for kidney disease progression and cardiovascular risk. The study enrolled 242 participants and evaluated once-daily doses of 10 or 20 mg of finerenone over a six-month period.
FINE-ONE is the first Phase III study since the 1990s to focus on patients with both T1D and CKD. Elevated UACR in this population is associated with increased risk for cardiovascular events and kidney function decline. The trial investigated UACR as a bridging biomarker to assess the potential impact of treatment on long-term kidney outcomes.
Safety outcomes in FINE-ONE were generally consistent with previous trials of finerenone in type 2 diabetes. The rate of treatment-emergent adverse events was 47.1% for finerenone and 49.2% for placebo. Serious adverse events occurred in 11.8% and 11.5% of participants, respectively. Hyperkalemia was observed in 10.1% of patients receiving finerenone, compared to 3.3% with placebo, with treatment discontinuation due to hyperkalemia occurring in 1.7% and 0% of cases.
Finerenone is currently approved in the United States for reducing cardiovascular and kidney risks in adults with CKD associated with type 2 diabetes. In July 2025, it also received approval for the treatment of heart failure with preserved ejection fraction. Bayer plans to submit a supplemental New Drug Application to the U.S. Food and Drug Administration based on FINE-ONE results in 2026.
In addition to the FINE-ONE data, results from the CONFIDENCE trial were also presented at ASN 2025. This Phase II study evaluated the combination of finerenone and a sodium-glucose cotransporter 2 inhibitor (SGLT2i) in patients with T2D and CKD. Findings from CONFIDENCE will be highlighted in the “Best of the Journal of the American Medical Association and the New England Journal of Medicine” session.
FINE-ONE is part of Bayer’s broader FINEOVATE clinical development program, which includes ongoing Phase III trials investigating finerenone in heart failure and CKD populations.