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Cited by 184Chronic Kidney Disease and DiabetesAcute Kidney Injury ResearchDiabetes Treatment and Management

Design and Baseline Characteristics of the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease Trial

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Bakris, George L., Agarwal, Rajiv, Anker, Stefan D., Pitt, Bertram, Ruilope, Luis M., Nowack, Christina, Kolkhof, Peter, Ferreira, Anna C. +3 more·2019·American Journal of Nephrology
DOI 10.1159/000503713PMC PMC6888890
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Abstract

Background: Among diabetics, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality, and progression of their underlying disease. Finerenone is a novel, non-steroidal, selective mineralocorticoid-receptor antagonist which has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD), while revealing only a low risk of hyperkalemia. However, the effect of finerenone on renal and CV outcomes has not been investigated in long-term trials yet. Methods: The Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease ­(FIDELIO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important renal and CV outcomes in T2D patients with CKD. FIDELIO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 5.5 years. FIDELIO-DKD randomized 5,734 patients with an estimated glomerular filtration rate (eGFR) ≥25–<75 mL/min/1.73 m 2 and albuminuria (urinary albumin-to-creatinine ratio ≥30–≤5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of primary outcome (overall two-sided significance level α = 0.05), the composite of time to first occurrence of kidney failure, a sustained decrease of eGFR ≥40% from baseline over at least 4 weeks, or renal death. Conclusion: FIDELIO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of renal and CV events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen.

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  • To account for multiple testing, the weighted Bonferroni-Holm procedure was used for the primary outcome and the key secondary outcome, followed by a hierarchical testing procedure of additional secondary outcomes.

    “To account for multiple testing, the weighted Bonferroni-Holm procedure was used for the primary outcome and the key secondary outcome, followed by a hierarchical testing procedure of additional secondary outcomes, as described previously.16”

    From Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes (2020) · cites this paper as [16]

    The Statistical Considerations—Statistical Analyses section specifies the weighted Bonferroni-Holm procedure for the primary renal and key secondary cardiovascular endpoints, followed by hierarchical testing of further secondary endpoints. As a design paper, however, it says these procedures “will be used”; it does not establish that they were actually used. (LLM, conf=0.82)

    Experimental — accuracy not yet measured

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Authors
Bakris, G. L., Agarwal, R., Anker, S. D., Pitt, B., Ruilope, L. M., Nowack, C., Kolkhof, P., Ferreira, A. C., Schloemer, P., Filippatos, G., & on behalf of the FIDELIO-DKD study investigators
Affiliations
  • University of Chicago (US)
  • Richard L. Roudebush VA Medical Center (US)
  • German Centre for Cardiovascular Research (DE)
  • University of Michigan (US)
  • Research Institute Hospital 12 de Octubre (ES)
  • Bayer (Germany) (DE)
  • University of Cyprus (CY)
ORCID
Venue
American Journal of Nephrology
Publisher
S. Karger AG
Published
2019
Volume
50
Issue
5
Pages
333-344
ISSN
  • 0250-8095 (ISSN-L)
  • 1421-9670
DOI
10.1159/000503713
PMC
PMC6888890
OpenAlex
W2982024515
Cited by
184
References
10
Citations by year
2026: 16 · 2025: 14 · 2024: 22 · 2023: 23 · 2022: 28 · 2021: 35 · 2020: 44 · 2019: 1 · 2012: 1
FWCI
20.86
Type
journal article
Language
en
Open access
Licence
Locations
  • American Journal of Nephrology (publishedVersion, cc-by-nc-nd)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • Lirias (submittedVersion, other-oa)
  • National University of Singapore (submittedVersion)
  • ABACUS. Repositorio de Producción Científica (Universidad Europea) (submittedVersion, other-oa)
  • Archivio Istituzionale della Ricerca (Universita Degli Studi Di Milano) (submittedVersion, other-oa)
  • BOA (University of Milano-Bicocca) (submittedVersion, cc-by-nc-nd)
  • Bern Open Repository and Information System (University of Bern) (submittedVersion, cc-by-nc-nd)
  • LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, other-oa)
  • University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, cc-by-nc-nd)
  • Open Access CRIS of the University of Bern
Funders
  • Bayer
  • Barts Charity (MGD&U0002)
  • Bayer Canada
  • Bayer, United Kingdom
  • Bayer Korea
  • National Institute of Diabetes and Digestive and Kidney Diseases (R01DK104753)
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, diabetic nephropathy, type 2 diabetes, chronic kidney disease, mineralocorticoid receptor antagonists, renal failure, cardiovascular outcomes, renal outcomes, albuminuria, estimated glomerular filtration rate decline, renal death, trial design
MeSH terms
Aged, Albuminuria, Mineralocorticoid Receptor Antagonists, Diabetes Mellitus, Type 2, Diabetic Nephropathies, Double-Blind Method, Female, Glomerular Filtration Rate, Humans, Kidney Failure, Chronic, Male, Middle Aged, Naphthyridines, Research Design, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Treatment Outcome, Clinical Trials, Phase III as Topic, Disease Progression

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