Rationale and design of a randomised phase III registration trial investigating finerenone in participants with type 1 diabetes and chronic kidney disease: The FINE-ONE trial
Study context
- Population
- Adults with T1D, urine albumin/creatinine ratio (UACR) ≥200–<5000 mg/g (≥22.6–<565 mg/mmol) and eGFR ≥25–<90 ml/min/1.73 m²planned
- Participants
- ∼220 adults
- Planned comparison
- Finerenone vs placebo
- Primary endpoint
- Relative change in UACR from baseline
- Follow-up
- Over 6 months
Methodological detailsplacebo-controlled, double-blind, phase III, registration trial, Trial duration 7.5 months, Secondary outcomes: incidences of treatment-emergent AEs, treatment-emergent serious AEs and hyperkalaemia
- Placebo-controlled
- Double-blind
- Phase III
- Registration trial
- Trial duration 7.5 months
- Secondary outcomes: incidences of treatment-emergent AEs, treatment-emergent serious AEs and hyperkalaemia
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Rationale and design of a randomised phase III registration trial investigating finerenone in participants with type 1 diabetes and chronic kidney disease: The FINE-ONE trial. Diabetes Res Clin Pract. Published 5 October 2023. doi:10.
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