Evidence map›Paper›PMID 31655812›Full record

ArticleAmerican journal of nephrology2019

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

George L Bakris, Rajiv Agarwal, Stefan D Anker, Bertram Pitt, Luis M Ruilope, Christina Nowack, Peter Kolkhof, Anna C Ferreira, Patrick Schloemer, Gerasimos Filippatos and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in American journal of nephrology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02540993 (A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate the Safety and Efficacy of Finerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease), which is not on this map. Cited by 78 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 4 pooled it
17.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02540993 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate the Safety and Efficacy of Finerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

TypeinterventionalSponsorBayerRan2015 to 2020Enrolled5,734ConditionsChronic Kidney DiseaseArmsFinerenone (BAY94-8862), Placebo
3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 4 syntheses or guidelines pooled it, 175 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Trial
  6. Finerenone in People with CKD, Type 2 Diabetes, and History of Nephrectomy.Clinical journal of the American Society of Nephrology : CJASN · 2026
    Trial
  7. Trial
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  17. The dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial: baseline characteristics.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2020
    Trial
  18. Review
  19. Article
  20. Effect of Finerenone on Morbidity and Mortality in CKD.Journal of the American Society of Nephrology : JASN · 2026
    Article

18 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 5 countries.

George L BakrisDepartment of Medicine, University of Chicago Medicine, Chicago, Illinois, USA, gbakris@gmail.com.
Rajiv AgarwalRichard L. Roudebush VA Medical Center and Indiana University, Indianapolis, Indiana, USA.
Stefan D AnkerDepartment of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.
Bertram PittDepartment of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan, USA.
Luis M RuilopeCardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Hospital Universitario 12 de Octubre, Madrid, Germany.
Christina NowackResearch and Development, Clinical Development Operations, Bayer AG, Wuppertal, Germany.
Peter KolkhofResearch and Development, Preclinical Research Cardiovascular, Bayer AG, Wuppertal, Germany.
Anna C FerreiraResearch and Development, Clinical Operations, Bayer SA, São Paulo, Brazil.
Patrick SchloemerResearch and Development, Statistics and Data Insights, Bayer AG, Berlin, Germany.
Gerasimos FilippatosDepartment of Cardiology, Attikon University Hospital, Athens, Greece.
on behalf of the FIDELIO-DKD study investigators
FIDELIO-DKD study investigators
Bayer (Germany) · DECentro de Investigación en Red en Enfermedades Cardiovasculares · ESGerman Centre for Cardiovascular Research · DERichard L. Roudebush VA Medical Center · USUniversity of Cyprus · CYUniversity of Illinois Chicago · USUniversity of Michigan · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAmong 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.

methodsThe 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 m2 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.

conclusionFIDELIO-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.

Indexed as

AgedAlbuminuriaClinical Trials, Phase III as TopicDiabetes Mellitus, Type 2Diabetic NephropathiesDisease ProgressionDouble-Blind MethodFemaleGlomerular Filtration RateHumansKidney Failure, ChronicMaleMiddle AgedMineralocorticoid Receptor AntagonistsMulticenter Studies as TopicNaphthyridinesfinerenoneMineralocorticoid Receptor AntagonistsNaphthyridinesAldosteroneClinicalDiabetesKidneyMineralocorticoidOutcomes

Identifiers

PMID31655812
PMCPMC6888890
OpenAlexW2982024515

What OpenQuestion holds

Textmetadata
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.