Late-breaking results from the pivotal Phase III FINE-ONE study show that finerenone significantly reduces the urine albumin-to-creatinine ratio (UACR) in adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D).² The findings, presented at the American Society of Nephrology’s Kidney Week 2025, mark the first positive Phase III results for a new therapy in this high-risk population in over 30 years.²
Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist designed to block the harmful effects of MR overactivation, which contributes to CKD progression and cardiovascular damage.
The FINE-ONE study was a global, randomised, double-blind, placebo-controlled Phase III trial that enrolled 242 participants with CKD and T1D across 80 sites.² Participants were assigned 1:1 to receive either finerenone (10 mg or 20 mg once daily) or a matching placebo, in addition to standard of care. The primary objective was to assess the superiority of finerenone over placebo in reducing UACR from baseline over a six-month period.²
The study met its primary endpoint, with finerenone demonstrating a statistically significant 25% relative reduction in UACR from baseline over six months compared to placebo (least squares geometric mean ratio 0.75; 95% CI, 0.65-0.87; p=0.0001).²
A key secondary finding showed that 68.1% of participants in the finerenone arm achieved at least a 30% reduction in UACR at any point post-baseline, compared to 46.6% in the placebo arm.² The safety profile of finerenone was consistent with previous studies. Hyperkalaemia-related adverse events were more frequent with finerenone (10.1%) than placebo (3.3%), but there were no fatal events and discontinuation rates were low.²
These results address a significant unmet need for patients with CKD and T1D, who face a high residual risk of kidney failure and cardiovascular events despite current therapies. Dr Hiddo Lambers Heerspink, Chair of the study’s Steering Committee, commented, "The positive results of the FINE-ONE study represent a landmark moment and give hope to patients with chronic kidney disease associated with type 1 diabetes who currently have very limited treatment options."²
The findings in T1D add to a growing body of evidence for finerenone across the spectrum of cardiovascular-kidney-metabolic (CKM) conditions. A separate pooled analysis of the FIDELIO-DKD, FIGARO-DKD, and FINEARTS-HF trials in patients with T2D or heart failure demonstrated that finerenone consistently reduced adverse cardiovascular outcomes regardless of baseline body mass index or waist-to-height ratio, suggesting broad applicability in high-risk CKM populations.¹
Bayer plans to submit the data from the FINE-ONE study to health authorities for regulatory assessment.²
This study was funded by Bayer.
References
1. Ostrominski JW, Harrington J, Claggett BL, et al. Anthropometric Measures, Cardiovascular Outcomes, and Treatment Effects of Finerenone in Cardiovascular-Kidney-Metabolic Disease: Pooled Participant-Level Analysis of 3 Global Trials. JACC. 2025;86(20):1781-1801. https://doi.org/10.1016/j.jacc.2025.08.039
2. Bayer. Finerenone showed statistically significant reduction of UACR in adults with chronic kidney disease associated with type 1 diabetes. 6 November 2025. https://www.bayer.com/media/en-us/finerenone-showed-statistically-significant-reduction-of-uacr-in-adults-with-chronic-kidney-disease-associated-with-type-1-diabetes/
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