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. 2025 Feb 4;40(2):308-319.
doi: 10.1093/ndt/gfae132.

Design and baseline characteristics of the Finerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease (FIND-CKD) randomized trial

Hiddo J L Heerspink  1 , Rajiv Agarwal  2 , George L Bakris  3 , David Z I Cherney  4 , Carolyn S P Lam  5   6 , Brendon L Neuen  7   8 , Pantelis A Sarafidis  9 , Katherine R Tuttle  10   11 , Christoph Wanner  12 , Meike D Brinker  13 , Sara Dizayee  14 , Peter Kolkhof  15 , Patrick Schloemer  16 , Paula Vesterinen  17 , Vlado Perkovic  7 ; FIND-CKD investigators
Collaborators, Affiliations

Design and baseline characteristics of the Finerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease (FIND-CKD) randomized trial

Hiddo J L Heerspink et al. Nephrol Dial Transplant. .

Abstract

Background: Finerenone, a non-steroidal mineralocorticoid receptor antagonist, improved kidney and cardiovascular outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes in two phase 3 outcome trials. The Finerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease (FIND-CKD) study investigates the effect of finerenone in adults with CKD without diabetes.

Methods: FIND-CKD (NCT05047263 and EU CT 2023-506897-11-00) is a randomized, double-blind, placebo-controlled phase 3 trial in patients with CKD of non-diabetic aetiology. Adults with a urinary albumin:creatinine ratio (UACR) ≥200-≤3500 mg/g and an estimated glomerular filtration rate (eGFR) ≥25-<90 ml/min/1.73 m2 receiving a maximum tolerated dose of a renin-angiotensin system inhibitor were randomized 1:1 to once-daily placebo or finerenone 10 or 20 mg depending on eGFR >60 or <60 ml/min/1.73 m2. The primary efficacy outcome is total eGFR slope, defined as the mean annual rate of change in eGFR from baseline to month 32. Secondary efficacy outcomes include a combined cardiorenal composite outcome comprising time to kidney failure, sustained ≥57% decrease in eGFR, hospitalization for heart failure or cardiovascular death, as well as separate kidney and cardiovascular composite outcomes. Adverse events are recorded to assess tolerability and safety.

Results: Across 24 countries, 3231 patients were screened and 1584 were randomized to study treatment. The most common causes of CKD were chronic glomerulonephritis (57.0%) and hypertensive/ischaemic nephropathy (29.0%). Immunoglobulin A nephropathy was the most common glomerulonephritis (26.3% of the total population). At baseline, mean eGFR and median UACR were 46.7 ml/min/1.73 m2 and 818.9 mg/g, respectively. Diuretics were used by 282 participants (17.8%), statins by 851 (53.7%) and calcium channel blockers by 794 (50.1%). Sodium-glucose co-transporter 2 (SGLT2) inhibitors were used in 16.9% of patients; these individuals had a similar mean eGFR (45.6 versus 46.8 ml/min/1.73 m2) and a slightly higher median UACR (871.9 versus 808.3 mg/g) compared with those not using SGLT2 inhibitors at baseline.

Conclusions: FIND-CKD is the first phase 3 trial of finerenone in patients with CKD of non-diabetic aetiology.

Keywords: clinical trial; eGFR slope; finerenone; immunoglobulin A nephropathy; non-diabetic chronic kidney disease.

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Conflict of interest statement

This study is sponsored by Bayer AG. The authors wrote the article with the assistance of a medical writer funded by the sponsor. The sponsor was involved in the study design and the writing of the report. H.J.L.H. has received grants from AstraZeneca, Boehringer Ingelheim, Janssen and Novo Nordisk; consulting fees from AstraZeneca, Alexion, Bayer, Boehringer Ingelheim, CSL Behring, Chinook, Dimerix, Eli Lilly, Gilead, Janssen, Merck, Mitsubishi Tanabe, Novartis, Novo Nordisk and Travere Therapeutics and payments or honoraria for speaking from AstraZeneca. R.A. has received personal fees and non-financial support from Bayer Healthcare Pharmaceuticals; personal fees and non-financial support from Akebia Therapeutics, Boehringer Ingelheim, Eli Lilly and Vifor Pharma; serves as a member of data safety monitoring committees for Chinook and Vertex Pharmaceuticals; serves as a member of steering committees of randomized trials for Akebia Therapeutics and Bayer; serves as Associate Editor for the American Journal of Nephrology and Nephrology Dialysis Transplantation and as an author for UpToDate and has received research grants from the US Veterans Administration and the National Institutes of Health. At the time of the study, G.B. received support from T32 NIH grant DK07011 and was a consultant to Bayer, KBP Biosciences, Ionis, Alynylam, AstraZeneca, Quantum Genomics, Novo Nordisk, Dia Medica Therapeutics and inREGEN. D.Z.I.C. has received honoraria from AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, CSL Behring, Eli Lilly, Janssen, Maze, Merck, Mitsubishi Tanabe, Novartis, Novo Nordisk Otsuka, Prometic, Sanofi, Lexicon and Yeungene and operational funding for clinical trials from AstraZeneca, Boehringer Ingelheim, CSL Behring, Eli Lilly, Janssen, Merck, Novo Nordisk and Sanofi. C.S.P.L. is supported by a Clinician Scientist Award from the National Medical Research Council of Singapore; has received research support from Novo Nordisk and Roche Diagnostics; has served as consultant or on the advisory board/steering committee/executive committee for Alleviant Medical, Allysta Pharma, AnaCardio AB, Applied Therapeutics, AstraZeneca, Bayer, Biopeutics, Boehringer Ingelheim, Boston Scientific, BMS, CardioRenal, Cytokinetics, Darma, EchoNous, Eli Lilly, Impulse Dynamics, Intellia Therapeutics, Ionis Pharmaceutical, Janssen Research & Development, Medscape/WebMD Global, Merck, Novartis, Novo Nordisk, Prosciento, Quidel, Radcliffe Group, Recardio, ReCor Medical, Roche Diagnostics, Sanofi, Siemens Healthcare Diagnostics and Us2.ai and serves as co-founder and non-executive director of Us2.ai. B.L.N. has received fees for travel support, advisory boards, scientific presentations and steering committee roles from AstraZeneca, Bayer, Boehringer Ingelheim, Cornerstone Medical Education, Limbic, Cambridge Healthcare Research, Janssen and Travere Therapeutics, with all honoraria paid to his institution. P.S. has received honoraria for advisory boards from AstraZeneca, Bayer, Innovis Pharma, Primeview, Healthink, Recor Medical, Boehringer Ingelheim, Menarini and Baxter; speaker fees from Winmedica, Boehringer Ingelheim, Bayer, Sanofi, AstraZeneca, Genesis Pharma, Astellas, Springer, Menarini, Peervoice, WebMD and AICME; research support from Boehringer Ingelheim, Genesis Pharma and Vianex; and is a member of steering committees for Bayer and CSL Behring. K.R.T. reports consultancy for Bayer, Boehringer Ingelheim, Novo Nordisk; research funding from Bayer and Travere Therapeutics; honoraria from Bayer, Boehringer Ingelheim and Novo Nordisk; other from Eli Lilly; personal fees and other from Boehringer Ingelheim; grants, personal fees and other from Bayer AG and Novo Nordisk and grants from Travere Therapeutics, outside the submitted work. C.W. has received personal fees from AstraZeneca, Bayer, Boehringer Ingelheim, CSL-Vifor, Eli Lilly, GSK, MSD, Novo Nordisk and Sanofi. P.K. is a full-time employee of Bayer AG, Germany. M.B., S.D. and P.S. are full-time employees of Bayer AG, Germany, and report ownership interest in Bayer AG. P.V. is a full-time employee of Bayer AG, Finland, and reports ownership interest in Bayer AG. V.P. has received fees for an advisory board, steering committee or scientific presentation from AbbVie, Amgen, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Chinook Therapeutics, CSL Vifor, Gilead, GSK, Janssen, Medimmune, Mitsubishi-Tanabe, Mundipharma, Novartis, Novo Nordisk, Otsuka and Travere Therapeutics; received speaker fees from Janssen; served on a data and safety monitoring committee for Dimerix; served on the board of directors for George Clinical, Garvan Institute, George Institute, Victor Chang Cardiac Research Institute, Ingham Institute and Mindgardens Neuroscience Network; and has stock in George Clinical.

Figures

Graphical Abstract
Graphical Abstract
Figure 1:
Figure 1:
Key eligibility criteria. aTo ensure a pre-specified ratio for a population at risk of progressive renal function decline, the number of participants with an eGFR ≥25–<60 ml/min/1.73 m2 and UACR ≥200–<500 mg/g is planned to be capped at ≈10% of the total population. DBP: diastolic blood pressure; HbA1c: glycated haemoglobin; HF: heart failure; SBP: systolic blood pressure; T1D: type 1 diabetes.
Figure 2:
Figure 2:
Study design of FIND-CKDa. aStudy duration and the number of study visits will depend on the time of enrolment of the patient. bStarting dose of finerenone is based on the patient's eGFR level at the screening visit. Finerenone will be up- or down-titrated based on potassium and eGFR levels. cParticipants will stay in the study until the last randomized participant has reached 32 months of treatment. EOT: end of treatment; RND: randomization.
Figure 3:
Figure 3:
Kidney disease aetiology by region. FSGS: focal segmental glomerulosclerosis; MesPGN: mesangial proliferative glomerulonephritis.
See this image and copyright information in PMC

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