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Open Access Green möglich sobald Postprint bei der ZB eingereicht worden ist.
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)
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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Publikationstyp
Artikel: Journalartikel
Dokumenttyp
Wissenschaftlicher Artikel
Schlagwörter
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
Zeitschrift
Diabetes Research and Clinical Practice
Quellenangaben
Band: 204,
Artikelnummer: 110908
Verlag
Elsevier
Verlagsort
Elsevier House, Brookvale Plaza, East Park Shannon, Co, Clare, 00000, Ireland
Nichtpatentliteratur
Publikationen
Begutachtungsstatus
Peer reviewed
Förderungen
Bayer AG