FINE-ONE Study Outcome
The FINE-ONE study is an ongoing phase III trial that has not yet reported outcomes—it is designed to evaluate finerenone versus placebo in patients with type 1 diabetes and chronic kidney disease, using change in urinary albumin-to-creatinine ratio (UACR) as the primary endpoint over 6 months. 1
Study Design and Current Status
FINE-ONE (NCT05901831) is a randomized, placebo-controlled, double-blind phase III trial with a planned duration of 7.5 months enrolling approximately 220 adults with type 1 diabetes 1
Eligible participants must have UACR ≥200 to <5000 mg/g (≥22.6 to <565 mg/mmol) and eGFR ≥25 to <90 mL/min/1.73 m² 1
The primary endpoint is the relative change in UACR from baseline over 6 months, using UACR as a bridging biomarker since finerenone's treatment effect on UACR was associated with its efficacy on kidney outcomes in type 2 diabetes trials 1
Rationale for the Study
Despite guideline-recommended treatments including renin-angiotensin system inhibition, up to 40% of individuals with type 1 diabetes develop chronic kidney disease, putting them at risk of kidney failure 1
Finerenone is already approved to reduce the risk of kidney failure in individuals with type 2 diabetes based on the FIDELIO-DKD and FIGARO-DKD trials, which demonstrated an 18% reduction in kidney composite outcomes (HR 0.82,95% CI 0.73-0.93) and 36% reduction in end-stage kidney disease (HR 0.64,95% CI 0.41-0.995) 2
The FIDELITY pooled analysis of 13,026 patients with type 2 diabetes showed a 23% reduction in composite kidney outcomes (HR 0.77,95% CI 0.67-0.88) across the spectrum of CKD severity 2
Regulatory Context
Based on regulatory authority feedback, UACR can be used as a bridging biomarker for kidney outcomes to support registration of finerenone in type 1 diabetes, provided necessary criteria are met 1
In type 2 diabetes trials, early albuminuria reduction mediated 84% of the treatment effect on kidney outcomes when analyzed as a continuous variable, and 64% when using the guideline-recommended 30% reduction threshold 3
Secondary Outcomes Being Evaluated
Secondary outcomes in FINE-ONE include incidences of treatment-emergent adverse events, treatment-emergent serious adverse events, and hyperkalemia 1
This safety monitoring is critical given that hyperkalemia occurred in 10.8% versus 5.3% with placebo in the type 2 diabetes trials, though discontinuation rates remained low at 1.2% for finerenone versus 0.4% for placebo 2, 4
Clinical Significance if Successful
If FINE-ONE demonstrates efficacy, finerenone could become the first registered treatment for CKD associated with type 1 diabetes in almost 30 years 1
This would address a critical unmet need, as current evidence for finerenone's cardiovascular and kidney benefits is limited to type 2 diabetes populations with eGFR 25-90 mL/min/1.73 m² and albuminuria 2, 5