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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Standard

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

Harvard

Heerspink, HJL, Birkenfeld, AL, Cherney, DZI, Colhoun, HM, Ji, L, Mathieu, C, Groop, PH, Pratley, RE, Rosas, SE, Rossing, P, Skyler, JS, Tuttle, KR, Lawatscheck, R, Scott, C, Edfors, R, Scheerer, MF, Kolkhof, P & McGill, JB 2023, '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 Research and Clinical Practice, bind 204, 110908. https://doi.org/10.1016/j.diabres.2023.110908

APA

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. F., Kolkhof, P., & McGill, J. B. (2023). 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 Research and Clinical Practice, 204, [110908]. https://doi.org/10.1016/j.diabres.2023.110908

Vancouver

Heerspink HJL, Birkenfeld AL, Cherney DZI, Colhoun HM, Ji L, Mathieu C o.a. 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 Research and Clinical Practice. 2023;204. 110908. https://doi.org/10.1016/j.diabres.2023.110908

Author

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. / 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. I: Diabetes Research and Clinical Practice. 2023 ; Bind 204.

Bibtex

@article{c2cdcd37f0804b69a8b110f1e3e39603,
title = "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",
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{\textquoteright} 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.",
keywords = "Albuminuria, Chronic kidney disease, Finerenone, Type 1 diabetes",
author = "Heerspink, {Hiddo J.L.} and Birkenfeld, {Andreas L.} and Cherney, {David Z.I.} and Colhoun, {Helen M.} and Linong Ji and Chantal Mathieu and Groop, {Per Henrik} and Pratley, {Richard E.} and Rosas, {Sylvia E.} and Peter Rossing and Skyler, {Jay S.} and Tuttle, {Katherine R.} and Robert Lawatscheck and Charlie Scott and Robert Edfors and Scheerer, {Markus F.} and Peter Kolkhof and McGill, {Janet B.}",
note = "Publisher Copyright: {\textcopyright} 2023 The Authors",
year = "2023",
doi = "10.1016/j.diabres.2023.110908",
language = "English",
volume = "204",
journal = "Diabetes Research and Clinical Practice. Supplement",
issn = "1572-1671",
publisher = "Elsevier Ireland Ltd",

}

RIS

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