Evidence mapPaperPMID 41915602Full record

ArticleAmerican journal of nephrology2026

Effect of Finerenone Treatment Discontinuation on Kidney and Cardiovascular Outcomes: A Fidelity Analysis.

Ajay K Singh, Stefan D Anker, Bertram Pitt, Peter Rossing, Luis M Ruilope, Christiane Ahlers, Youssef M K Farag, Marc Lambelet, Meike Brinker, Katja Rohwedder and 2 more

2 registry-linked trialsAbstract read
In one paragraph

Article in American journal of nephrology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
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
NCT02545049 phase3completednot on this map

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

TypeinterventionalSponsorBayerRan2015 to 2021Enrolled7,352ConditionsDiabetic Kidney DiseaseArmsFinerenone (BAY94-8862), Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Ajay K SinghHarvard Medical School, Renal Division, Brigham and Women's Hospital/Dana Farber Cancer Institute, Boston, Massachusetts, USA, ajay_singh@hms.harvard.edu.
Stefan D AnkerDepartment of Cardiology (CVK) of German Heart Center Charité, German Centre for Cardiovascular Research (DZHK) partner site Berlin, Charité Universitätsmedizin, Berlin, Germany.
Bertram PittDepartment of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan, USA.
Peter RossingSteno Diabetes Center Copenhagen, Copenhagen, Denmark.
Luis M RuilopeCardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain.
Christiane AhlersStatistics and Data Insights, Bayer AG, Berlin, Germany.
Youssef M K FaragPostgraduate Medical Education, Harvard Medical School, Boston, Massachusetts, USA.
Marc LambeletChrestos GmbH, Essen, Germany.
Meike BrinkerCardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany.
Katja RohwedderCardio-Renal Medical Affairs Department, Bayer AG, Berlin, Germany.
Zihe ZhengMedical Affairs Cardio-Renal Division, Bayer U.S. LLC, Whippany, New Jersey, USA.
Gerasimos FilippatosNational and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens, Greece.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionFinerenone reduced the risk of heart and kidney events in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) in FIDELITY, a prespecified pooled analysis combining data from the phase III FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049) trials. This FIDELITY analysis aimed to identify and assess key predictors of finerenone discontinuation and evaluate the impact of discontinuation on its efficacy in people with CKD and T2D.

methodsAdults with CKD (urine albumin-to-creatinine ratio 30-≤5,000 mg/g, estimated glomerular filtration rate [eGFR] ≥25 mL/min/1.73 m2) and T2D on optimized renin-angiotensin system inhibition were randomized 1:1 to finerenone or placebo. Baseline characteristics were identified and assessed as predictors of treatment discontinuation using a multivariate Cox proportional hazards model. Stratified Cox models with treatment discontinuation as a time-varying covariate were used to assess the effect of treatment discontinuation on composite kidney and cardiovascular (CV) outcomes (kidney: kidney failure, sustained ≥57% eGFR decrease from baseline over at least 4 weeks, or kidney-related death; CV: CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure).

resultsAmong 12,990 participants included in the analysis, 22.8% and 21.6% prematurely discontinued treatment in the finerenone and placebo arms, respectively. Advanced age, White/Black race, lower eGFR, higher urine albumin-to-creatinine ratio, and higher serum potassium at baseline were identified as predictors of finerenone discontinuation. Crude event rates per 100 patient-years for the composite kidney and CV outcomes were lower with finerenone versus placebo under treatment (kidney: 1.09 vs. 1.71; CV: 2.98 vs. 3.78) as well as after discontinuation (kidney: 11.95 vs. 13.67; CV: 14.07 vs. 14.73). The effect of finerenone on composite kidney and CV outcomes appeared to be reduced after discontinuation (hazard ratio [HR] = 0.82; 95% confidence interval [CI] 0.66-1.02; HR = 0.93; 95% CI: 0.79-1.09, respectively) versus the time on-treatment (HR = 0.65; 95% CI: 0.54-0.78; p

conclusionIn FIDELITY, treatment discontinuation rates were similar in the finerenone and placebo arms. Finerenone demonstrated numerically higher kidney and CV benefits during treatment versus after discontinuation.

Indexed as

Cardiovascular outcomesChronic kidney diseaseKidney outcomesTreatment discontinuationType 2 diabetes

Identifiers

PMID41915602
PMCPMC13225798

What Socratic holds

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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 Socratic graph.