Evidence map›Paper›PMID 33198491›Full record

Trial reportCirculation2021

Finerenone and Cardiovascular Outcomes in Patients With Chronic Kidney Disease and Type 2 Diabetes.

Gerasimos Filippatos, Stefan D Anker, Rajiv Agarwal, Bertram Pitt, Luis M Ruilope, Peter Rossing, Peter Kolkhof, Patrick Schloemer, Ingo Tornus, Amer Joseph and 2 more

5 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Circulation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 150 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
150citing papers in PubMed, 7 pooled it
25.5field-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
NCT05593055 phase4recruitingnot on this mapstarted 2023, after this paper: background citation

Mineralocorticoid Receptor, Coronary Microvascular Function, and Cardiac Efficiency in Hypertension

TypeinterventionalSponsorBrigham and Women's HospitalRan2023 to 2027Enrolled75ConditionsHypertension, Left Ventricular HypertrophyArmsEplerenone, Chlorthalidone, Potassium
NCT06301022 unknown statusnot on this mapstarted 2022, after this paper: background citation

Effectiveness and Safety of Finerenone in Chinese CKD Patients Without Diabetes Mellitus: A Real-world Retrospective Study

TypeobservationalSponsorFirst Affiliated Hospital of Harbin Medical UniversityRan2022 to 2024Enrolled90ConditionsChronic Kidney Diseases
NCT06457074 phase4recruitingnot on this mapstarted 2024, after this paper: background citation

Finerenone for Patients With Primary Aldosteronism (FAIRY): A Multicenter, Randomized Clinical Trial

TypeinterventionalSponsorQifu LiRan2024 to 2026Enrolled306ConditionsPrimary AldosteronismArmsFinerenone Oral Tablet, Spironolactone Oral Tablet
NCT07356388 phase3active not recruitingnot on this mapstarted 2025, after this paper: background citation

An Study on the Efficacy and Safety of Finerenone in Proteinuria Patients After Kidney Transplantation

TypeinterventionalSponsorkewen Chen,MDRan2025 to 2028Enrolled54ConditionsKidney Transplantation Recipients, Proteinuria PatientsArmsExperimental Group, Control (Standard treatment)
3 · Its place in the literature

Who cites it

150 citing papers in PubMed, 7 syntheses or guidelines pooled it, 267 citations in OpenAlex.

  1. Pooled it
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  6. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
  7. Pooled it
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  12. Effects of canagliflozin versus finerenone on cardiorenal outcomes: exploratory post hoc analyses from FIDELIO-DKD compared to reported CREDENCE results.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2022 · on this map
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90 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 8 institutions in 5 countries.

Gerasimos FilippatosNational and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Greece (G.F.).
Stefan D AnkerDepartment of Cardiology, and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.).
Rajiv AgarwalRichard L. Roudebush VA Medical Center and Indiana University, Indianapolis (R.A.).
Bertram PittDepartment of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.).
Luis M RuilopeCardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain (L.M.R.).
Peter RossingSteno Diabetes Center Copenhagen, Gentofte, Denmark (P.R.).
Peter KolkhofResearch and Development, Preclinical Research Cardiovascular (P.K.), Bayer AG, Wuppertal, Germany.
Patrick SchloemerResearch and Development, Statistics and Data Insights (P.S.), Bayer AG, Wuppertal, Germany.
Ingo TornusCardiology and Nephrology Clinical Development (I.T., A.J.), Bayer AG, Wuppertal, Germany.
Amer JosephCardiology and Nephrology Clinical Development (I.T., A.J.), Bayer AG, Wuppertal, Germany.
George L BakrisDepartment of Medicine, University of Chicago Medicine, IL (G.L.B.).
FIDELIO-DKD Investigators
Bayer (Germany) · DEBerlin Institute of Health at Charité - Universitätsmedizin Berlin · DEMadrid Institute for Advanced Studies · ESNational and Kapodistrian University of Athens · GRRichard L. Roudebush VA Medical Center · USUniversity of Copenhagen · DKUniversity of Illinois Chicago · USUniversity of Michigan · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe FIDELIO-DKD trial (Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease) evaluated the effect of the nonsteroidal, selective mineralocorticoid receptor antagonist finerenone on kidney and cardiovascular outcomes in patients with chronic kidney disease and type 2 diabetes with optimized renin-angiotensin system blockade. Compared with placebo, finerenone reduced the composite kidney and cardiovascular outcomes. We report the effect of finerenone on individual cardiovascular outcomes and in patients with and without history of atherosclerotic cardiovascular disease (CVD).

methodsThis randomized, double-blind, placebo-controlled trial included patients with type 2 diabetes and urine albumin-to-creatinine ratio 30 to 5000 mg/g and an estimated glomerular filtration rate ≥25 to <75 mL per min per 1.73 m

resultsBetween September 2015 and June 2018, 13 911 patients were screened and 5674 were randomized; 45.9% of patients had CVD at baseline. Over a median follow-up of 2.6 years (interquartile range, 2.0-3.4 years), finerenone reduced the risk of the composite cardiovascular outcome compared with placebo (hazard ratio, 0.86 [95% CI, 0.75-0.99];

conclusionsAmong patients with chronic kidney disease and type 2 diabetes, finerenone reduced incidence of the composite cardiovascular outcome, with no evidence of differences in treatment effect based on preexisting CVD status. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02540993.

Indexed as

Cardiovascular DiseasesDiabetes Mellitus, Type 2Double-Blind MethodFemaleHumansMaleNaphthyridinesRenal Insufficiency, ChronicfinerenoneNaphthyridinescardiovascular diseasechronic kidney diseaseclinical trialfinerenonemineralocorticoid receptorprimary and secondary preventiontype 2 diabetes

Identifiers

PMID33198491
PMCPMC7864612
OpenAlexW3103813916

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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 Socratic graph.