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

Hiddo J L Heerspink, Andreas L Birkenfeld, David Z I Cherney, Helen M Colhoun, Linong Ji, Chantal Mathieu, Per-Henrik Groop, Richard E Pratley, Sylvia E Rosas, Peter Rossing, Jay S Skyler, Katherine R Tuttle, Robert Lawatscheck, Charlie Scott, Robert Edfors, Markus F Scheerer, Peter Kolkhof, Janet B McGill

4 Citations (Scopus)

Abstract

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.

Original languageEnglish
Article number110908
JournalDiabetes Research and Clinical Practice
Volume204
Pages (from-to)110908
ISSN0168-8227
DOIs
Publication statusPublished - Oct 2023

Keywords

  • Adult
  • Biomarkers
  • Diabetes Mellitus, Type 1/complications
  • Diabetes Mellitus, Type 2/complications
  • Diabetic Nephropathies/etiology
  • Double-Blind Method
  • Glomerular Filtration Rate
  • Humans
  • Renal Insufficiency, Chronic/drug therapy
  • Renal Insufficiency/complications
  • Chronic kidney disease
  • Albuminuria
  • Finerenone
  • Type 1 diabetes

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