Evidence mapPaperPMID 42027097Full record

Trial reportDiabetes, obesity & metabolism2026

Outcomes With Finerenone by Baseline Treatment Goals in Type 2 Diabetes and Chronic Kidney Disease: A FIDELITY Analysis.

João Sérgio Neves, Ana Rita Leite, Francisco Vasques-Nóvoa, Bertram Pitt, Gerasimos Filippatos, Luis M Ruilope, Peter Rossing, Stefan D Anker, Gianluigi Savarese, Charlie A B Scott and 3 more

2 registry-linked trialsAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Diabetes, obesity & metabolism, 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. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Trial
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

13 authors.

João Sérgio NevesRISE-Health, Department of Surgery and Physiology, Faculty of Medicine of the University of Porto, Porto, Portugal.ORCID https://orcid.org/0000-0002-8173-8255
Ana Rita LeiteRISE-Health, Department of Surgery and Physiology, Faculty of Medicine of the University of Porto, Porto, Portugal.ORCID https://orcid.org/0000-0002-4111-3787
Francisco Vasques-NóvoaRISE-Health, Department of Surgery and Physiology, Faculty of Medicine of the University of Porto, Porto, Portugal.ORCID https://orcid.org/0000-0001-9701-8538
Bertram PittDepartment of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan, USA.ORCID https://orcid.org/0000-0001-5880-275X
Gerasimos FilippatosDepartment of Cardiology, Attikon University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.ORCID https://orcid.org/0000-0002-5640-0332
Luis M RuilopeCardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain.ORCID https://orcid.org/0000-0001-6278-7951
Peter RossingSteno Diabetes Center Copenhagen, Copenhagen, Denmark.ORCID https://orcid.org/0000-0002-1531-4294
Stefan D AnkerDepartment of Cardiology (CVK) of German Heart Center Charité, German Centre for Cardiovascular Research (DZHK) Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.ORCID https://orcid.org/0000-0002-0805-8683
Gianluigi SavareseDepartment of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.ORCID https://orcid.org/0000-0001-7732-0887
Charlie A B ScottClinical Statistics and Analytics, Bayer Corporation, Whippany, New Jersey, USA.ORCID https://orcid.org/0000-0002-2816-4889
Andrea LageCardiology and Nephrology Clinical Development, Bayer SA, São Paulo, Brazil.ORCID https://orcid.org/0000-0002-9893-2759
Meike D BrinkerCardiology and Nephrology Clinical Development, Bayer AG, Leverkusen, Germany.ORCID https://orcid.org/0000-0002-1560-9535
João Pedro FerreiraRISE-Health, Department of Surgery and Physiology, Faculty of Medicine of the University of Porto, Porto, Portugal.ORCID https://orcid.org/0000-0002-2304-6138

Funding

Bayer AG
6 · The paper itself

Abstract

aimsThe American Diabetes Association recommends achieving treatment goals (glycated haemoglobin ≤ 53 mmol/mol [7.0%], blood pressure < 130/80 mmHg, low-density lipoprotein cholesterol < 1.81 mmol/L and use of sodium-glucose cotransporter-2 inhibitors or glucagon-like peptide-1 receptor agonists), to reduce cardiovascular and kidney complications in people with chronic kidney disease and type 2 diabetes. This exploratory study assessed whether treatment effects of finerenone versus placebo were modified by the number of treatment goals met at baseline. MATERIALS AND

methodsFIDELITY, a prespecified pooled analysis, combined participant-level data from the randomized, double-blind, multicentre phase III FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049) trials. Participants with type 2 diabetes and chronic kidney disease were randomized 1:1 to finerenone or placebo. Composite cardiovascular and kidney outcomes, hospitalization for heart failure or cardiovascular death, hospitalization for heart failure and treatment-emergent adverse events were assessed by subgroups based on the number of treatment goals achieved.

resultsAt baseline, 29%, 40%, 24% and 7% of participants had met 0, 1, 2 and ≥ 3 treatment goals, respectively. Those with more treatment goals met had fewer composite cardiovascular outcomes (events per 100 patient-years in the placebo group: 6.0, 5.1, 4.3 and 3.5 for 0, 1, 2 and ≥ 3 treatment goals, respectively). Similar patterns were observed for other outcomes. There was no heterogeneity in the effect of finerenone versus placebo on outcomes between subgroups. The safety profile of finerenone (vs. placebo) was similar across subgroups.

conclusionsFinerenone demonstrated treatment benefits in people with chronic kidney disease and type 2 diabetes, irrespective of treatment goals achieved at baseline.

Indexed as

Diabetes Mellitus, Type 2Diabetic NephropathiesNaphthyridinesRenal Insufficiency, ChronicAgedCardiovascular DiseasesDouble-Blind MethodFemaleGlycated HemoglobinGoalsHumansMaleMiddle AgedTreatment OutcomefinerenoneGlycated HemoglobinNaphthyridinescardiovascular complicationschronic kidney diseasefinerenonetype 2 diabetes

Identifiers

PMID42027097
PMCPMC13243951

What Socratic holds

Textmetadata
LicenceCC BY-NC
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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.