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Cited by 63Chronic Kidney Disease and DiabetesAcute Kidney Injury ResearchDiabetes Treatment and Management

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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Heerspink, Hiddo J.L., Birkenfeld, Andreas L., Cherney, David Z.I., Colhoun, Helen M., Ji, Linong, Mathieu, Chantal, Groop, Per-Henrik, Pratley, Richard E. +10 more·2023·Diabetes Research and Clinical Practice
DOI 10.1016/j.diabres.2023.110908
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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 m 2 . 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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  • Current evidence of kidney benefit is limited to CKD in type 2 diabetes.

    “while current evidence of kidney benefit is limited to CKD in type 2 diabetes, multiple studies are in progress to determine if these therapies also improve kidney outcomes in people with type 1 diabetes (149,150).”

    From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [150]

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  1. Kidney Disease: Improving Global Outcomes Diabetes Work Group. KDIGO 2022 Clinical practice guideline for diabetes management in chronic kidney disease. 2022. https://kdigo.org/wp-content/uploads/2022/03/KDIGO-2022-Diabetes- Management-GL_Public-Review-draft_1Mar2022.pdf [Accessed 11 July 2023].

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Authors
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.
Affiliations
  • University Medical Center Groningen (NL)
  • Helmholtz Munich (DE)
  • University Health Network (CA)
  • Institute of Genetics and Cancer (GB)
  • Peking University People's Hospital (CN)
  • KU Leuven (BE)
  • University of Helsinki (FI)
  • AdventHealth Orlando (US)
  • Joslin Diabetes Center (US)
  • University of Copenhagen (DK)
  • University of Miami (US)
  • University of Washington (US)
  • Bayer (Germany) (DE)
  • Bayer (United Kingdom) (GB)
  • Washington University in St. Louis (US)
Corresponding author
Heerspink, Hiddo J.L.
ORCID
Venue
Diabetes Research and Clinical Practice
Publisher
Elsevier BV
Published
2023-10
Volume
204
Pages
110908
ISSN
0168-8227 (ISSN-L)
DOI
10.1016/j.diabres.2023.110908
OpenAlex
W4387374139
Cited by
63
References
33
Citations by year
2026: 23 · 2025: 26 · 2024: 9 · 2023: 5
FWCI
12.24
Type
journal article
Language
en
Open access
Licence
Locations
  • Diabetes Research and Clinical Practice (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, cc-by)
  • University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion, cc-by)
  • Lirias (KU Leuven) (submittedVersion, cc-by-nc)
  • Digital Commons@Becker (Washington University School of Medicine) (submittedVersion, cc-by)
  • Työväentutkimus Vuosikirja (submittedVersion)
  • Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, cc-by)
  • PuSH - Publication Server of Helmholtz Zentrum München (submittedVersion, cc-by)
Funders
Bayer
Topics
  • Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
  • Health Sciences › Medicine › Nephrology › Acute Kidney Injury Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Keywords
finerenone, type 1 diabetes, chronic kidney disease, urine albumin-creatinine ratio, kidney failure prevention, renin-angiotensin system blockade, hyperkalemia, drug registration, trial design
MeSH terms
Adult, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetic Nephropathies, Double-Blind Method, Glomerular Filtration Rate, Humans, Naphthyridines, Biomarkers, Randomized Controlled Trials as Topic, Clinical Trials, Phase III as Topic, Renal Insufficiency, Chronic, Renal Insufficiency

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