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Heerspink, H.J.L.* ; Birkenfeld, A.L. ; Cherney, D.Z.I.* ; Colhoun, H.M.* ; Ji, L.* ; Mathieu, C.* ; Groop, P.H.* ; Pratley, R.E.* ; Rosas, S.E.* ; Rossing, P.* ; Skyler, J.S.* ; Tuttle, K.R.* ; Lawatscheck, R.* ; Scott, C.* ; Edfors, R.* ; Scheerer, M.* ; Kolkhof, P.* ; McGill, J.B.*

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. 204:110908 (2023)

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AIMS: Despite guideline-recommended treatments, including renin angiotensin system inhibition, up to 40 % of individuals with type 1 diabetes develop chronic kidney disease (CKD) putting them at risk of kidney failure. Finerenone is approved to reduce the risk of kidney failure in individuals with type 2 diabetes. We postulate that finerenone will demonstrate benefits on kidney outcomes in people with type 1 diabetes. METHODS: FINE-ONE (NCT05901831) is a randomised, placebo-controlled, double-blind phase III trial of 7.5 months' duration in ∼220 adults with type 1 diabetes, urine albumin/creatinine ratio (UACR) of ≥ 200-< 5000 mg/g (≥ 22.6-< 565 mg/mmol) and eGFR of ≥ 25-< 90 ml/min/1.73 m². RESULTS: The primary endpoint is relative change in UACR from baseline over 6 months. UACR is used as a bridging biomarker (BB), since the treatment effect of finerenone on UACR was associated with its efficacy on kidney outcomes in the type 2 diabetes trials. Based on regulatory authority feedback, UACR can be used as a BB for kidney outcomes to support registration of finerenone in type 1 diabetes, provided necessary criteria are met. Secondary outcomes include incidences of treatment-emergent adverse events, treatment-emergent serious adverse events and hyperkalaemia. CONCLUSIONS: FINE-ONE will evaluate the efficacy and safety of finerenone in type 1 diabetes and CKD. Finerenone could become the first registered treatment for CKD associated with type 1 diabetes in almost 30 years. TRIAL REGISTRATION: ClinicalTrials.gov NCT05901831.

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Publication type Article: Journal article

Document type Scientific Article

Corresponding Author

Keywords Albuminuria ; Chronic Kidney Disease ; Finerenone ; Type 1 Diabetes; Complications-trial/epidemiology; Renal Outcomes; Albuminuria; Microalbuminuria; Spironolactone; Interventions

ISSN (print) / ISBN 0168-8227

e-ISSN 1872-8227

Journal Diabetes Research and Clinical Practice

Quellenangaben Volume: 204, Article Number: 110908

Publisher Elsevier

Publishing Place Elsevier House, Brookvale Plaza, East Park Shannon, Co, Clare, 00000, Ireland

Non-patent literature Publications

Reviewing status Peer reviewed

Institute(s) Institute of Diabetes Research and Metabolic Diseases (IDM)

Grants Bayer AG