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Clinical Trial
. 2023 Oct:204:110908.
doi: 10.1016/j.diabres.2023.110908. Epub 2023 Oct 5.

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  1 , Andreas L Birkenfeld  2 , David Z I Cherney  3 , Helen M Colhoun  4 , Linong Ji  5 , Chantal Mathieu  6 , Per-Henrik Groop  7 , Richard E Pratley  8 , Sylvia E Rosas  9 , Peter Rossing  10 , Jay S Skyler  11 , Katherine R Tuttle  12 , Robert Lawatscheck  13 , Charlie Scott  14 , Robert Edfors  15 , Markus F Scheerer  16 , Peter Kolkhof  17 , Janet B McGill  18
Affiliations
Free article
Clinical Trial

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 et al. Diabetes Res Clin Pract. 2023 Oct.
Free article

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.

Keywords: Albuminuria; Chronic kidney disease; Finerenone; Type 1 diabetes.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: This study is sponsored by Bayer AG. The authors wrote the paper with the assistance of a medical writer funded by the sponsor. HJLH is a consultant for AstraZeneca, Bayer, Boehringer Ingelheim, Chinook, CSL Behring, Dimerix, Eli Lilly, Gilead, Janssen, Merck, Mitsubishi Tanabe, Novartis, Novo Nordisk and Travere. He received research support from AstraZeneca, Boehringer Ingelheim, Janssen and Novo Nordisk. ALB reports receiving personal fees from AstraZeneca, Bayer, Boehringer Ingelheim and Novo Nordisk paid to the University Clinic Tübingen. DZIC reports institutional grant funding from Boehringer Ingelheim, Eli Lilly, Merck, Janssen, Sanofi, AstraZeneca, CSL-Behring and Novo Nordisk and consultancy fees and honorarium from AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Bristol Myers Squibb, CSL-Behring, Gilead, Janssen, Lexicon, Maze, Merck, Mitsubishi-Tanabe, Novartis, Otsuka, Prometic, Sanofi, Youngene and Novo Nordisk. HMC reports trial advisory board fees from Bayer, Novo Nordisk, Regeneron, Sanofi and Eli Lilly; grant funding from AstraZeneca and Novo Nordisk; lecture fees from Medscape and owns shares in Bayer and Roche. LJ reports receiving consulting or lecture fees from Eli Lilly, Novo Nordisk, Merck, Bayer, Sanofi-Aventis, Roche, MSD, Medtronic, AstraZeneca, Boehringer Ingelheim and Abbott. CM serves or has served on the advisory panel for ActoBio Therapeutics, AstraZeneca, Avotres, Boehringer Ingelheim, Eli Lilly, Imcyse, Insulet, Mannkind, Medtronic, Merck Sharp and Dohme Ltd., Novartis, Novo Nordisk, Pfizer, Roche, Sanofi, Vertex and Zealand Pharma. Financial compensation for these activities has been received by KU Leuven; KU Leuven has received research support for CM from ActoBio Therapeutics, Imcyse, Medtronic, Novo Nordisk and Sanofi; CM serves or has served on the speaker’s bureau for AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, Sanofi and Novartis. Financial compensation for these activities has been received by KU Leuven. P-HG reports receiving lecture honoraria from Astellas, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Medscape, MSD, Mundipharma, Novo Nordisk, PeerVoice, Sanofi and SCIARC; and being an advisory board member of Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Elo Water, Medscape, MSD, Mundipharma, Nestlé, Novo Nordisk, PeerVoice, Sanofi and SCIARC. REP reports grants from Hanmi Pharmaceutical Co, Janssen and Poxel SA; consulting fees from Merck, Pfizer, Scohia Pharma, Inc. and Sun Pharmaceutical Industries; grants, speaker fees and consulting fees from Novo Nordisk; and grants and consulting fees from Sanofi. REP’s services were paid for directly to AdventHealth, a non-profit organisation. SER participated in at least one advisory board for AstraZeneca, Bayer and Traverse. Joslin Diabetes Center receives research support from AstraZeneca and Bayer. PR reports personal fees from Bayer; has received research support and personal fees from AstraZeneca and Novo Nordisk; and personal fees from Astellas, Boehringer Ingelheim, Eli Lilly, MSD, Gilead and Sanofi. All fees given to Steno Diabetes Center Copenhagen. JSS has been an advisor to 4Immune, Abvance, Adocia, Altheia, Arecor, AstraZeneca, Avotres, Bayer, COUR, Cue Biopharma, Dance Biopharm/Aerami, Dexcom, Diasome, Enthera, Imcyse, Immunomolecular Therapeutics, Kriya, Novo Nordisk, Oramed, Orgenesis, Precigen/ActoBiotics, Provention Bio, Sanofi, Signos, Vertex and Viacyte. JSS is also a member of the Board of Directors of Applied Therapeutics and Chair of the Strategic Advisory Board of the EU INNODIA consortium. KRT reports consultancy fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novo Nordisk and Travere; grant support from Bayer and Travere; and speaker fees from AstraZeneca, Eli Lilly and Novo Nordisk. RL is an employee of Bayer AG, Germany. CS is an employee of Bayer PLC, UK. RE is an employee of Bayer AB, Sweden. MFS is an employee of Bayer AG, Germany. MFS is also a shareholder in AstraZeneca, Bayer AG, Eli Lilly and Novo Nordisk. PK is an employee of Bayer AG, Germany. PK is s a co-inventor of finerenone and holds US and European patents relating to finerenone (US8436180B2 and EP2132206B1). JBM reports personal fees from Bayer, ClearNote Health, Gilead, Mannkind, Provention Bio and Thermo Fisher. JBM has received research support and personal fees from Novo Nordisk and research support from Beta Bionics, Dexcom and Medtronic.

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