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
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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. / Heerspink, Hiddo J.L.; Birkenfeld, Andreas L.; Cherney, David Z.I.; Colhoun, Helen M.; Ji, Linong; Mathieu, Chantal; Groop, Per Henrik; Pratley, Richard E.; Rosas, Sylvia E.; Rossing, Peter; Skyler, Jay S.; Tuttle, Katherine R.; Lawatscheck, Robert; Scott, Charlie; Edfors, Robert; Scheerer, Markus F.; Kolkhof, Peter; McGill, Janet B.
I: Diabetes Research and Clinical Practice, Bind 204, 110908, 2023.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Rationale and design of a randomised phase III registration trial investigating finerenone in participants with type 1 diabetes and chronic kidney disease
T2 - The FINE-ONE trial
AU - Heerspink, Hiddo J.L.
AU - Birkenfeld, Andreas L.
AU - Cherney, David Z.I.
AU - Colhoun, Helen M.
AU - Ji, Linong
AU - Mathieu, Chantal
AU - Groop, Per Henrik
AU - Pratley, Richard E.
AU - Rosas, Sylvia E.
AU - Rossing, Peter
AU - Skyler, Jay S.
AU - Tuttle, Katherine R.
AU - Lawatscheck, Robert
AU - Scott, Charlie
AU - Edfors, Robert
AU - Scheerer, Markus F.
AU - Kolkhof, Peter
AU - McGill, Janet B.
N1 - Publisher Copyright: © 2023 The Authors
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
KW - Albuminuria
KW - Chronic kidney disease
KW - Finerenone
KW - Type 1 diabetes
U2 - 10.1016/j.diabres.2023.110908
DO - 10.1016/j.diabres.2023.110908
M3 - Journal article
C2 - 37805000
AN - SCOPUS:85174661979
VL - 204
JO - Diabetes Research and Clinical Practice. Supplement
JF - Diabetes Research and Clinical Practice. Supplement
SN - 1572-1671
M1 - 110908
ER -
ID: 375967972