Evidence mapPaperPMID 41533467Full record

Trial reportClinical journal of the American Society of Nephrology : CJASN2026

Finerenone in People with CKD, Type 2 Diabetes, and History of Nephrectomy.

Jair Munoz Mendoza, Matthew R Weir, Stefan D Anker, Gerasimos Filippatos, Peter Rossing, Christiane Ahlers, Meike Brinker, Samuel T Fatoba, Andrea Horvat-Broecker, Katja Rohwedder and 2 more

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

Trial report in Clinical journal of the American Society of Nephrology : CJASN, 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.

Jair Munoz MendozaKatz Family Division of Nephrology and Hypertension, Department of Medicine, Peggy and Harold Katz Family Drug Discovery Center, University of Miami, Miller School of Medicine, Miami, Florida.ORCID 0009-0006-0669-6055
Matthew R WeirDepartment of Medicine, University of Maryland School of Medicine, Baltimore, Maryland.ORCID 0000-0001-8820-5702
Stefan D AnkerDepartment of Cardiology (CVK) of German Heart Center Charité, German Centre for Cardiovascular Research (DZHK) Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany.
Gerasimos FilippatosDepartment of Cardiology, School of Medicine, Attikon University Hospital, National and Kapodistrian University of Athens, Athens, Greece.ORCID 0000-0002-5640-0332
Peter RossingSteno Diabetes Center Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-1531-4294
Christiane AhlersStatistics and Data Insights, Bayer AG, Wuppertal, Germany.
Meike BrinkerCardiology and Nephrology Clinical Development, Bayer AG, Wuppertal, Germany.ORCID 0000-0002-1560-9535
Samuel T FatobaBayer US, LLC, Medical Affairs, Whippany, New Jersey.
Andrea Horvat-BroeckerBayer AG, Medical Affairs and Pharmacovigilance, Wuppertal, Germany.
Katja RohwedderCardio-Renal Medical Affairs Department, Bayer AG, Berlin, Germany.
Alessia FornoniKatz Family Division of Nephrology and Hypertension, Department of Medicine, Peggy and Harold Katz Family Drug Discovery Center, University of Miami, Miller School of Medicine, Miami, Florida.ORCID 0000-0002-1313-7773
FIDELIO-DKD and FIGARO-DKD Investigators

Funding

Bayer AG
6 · The paper itself

Abstract

key pointsFinerenone reduced albuminuria versus placebo in patients with a history of nephrectomy, similar to those without a history of nephrectomy. Incidences of treatment-emergent adverse events or serious adverse events were generally similar in patients with and without history of nephrectomy. Finerenone may delay kidney disease progression in patients with CKD and type 2 diabetes, irrespective of nephrectomy status.

backgroundFinerenone significantly reduced the risk of cardiovascular and kidney outcomes in patients with CKD and type 2 diabetes (T2D) in FIDELITY, a prespecified pooled analysis of two phase 3 trials. This post hoc FIDELITY analysis examined the efficacy and safety of finerenone in patients with CKD, T2D, and a history of nephrectomy.

methodsPatients in FIDELITY were randomized to receive finerenone or placebo and were on optimized renin-angiotensin system inhibition. We identified nephrectomy status using patients' medical history and assessed CKD progression in patients by nephrectomy status at baseline by modeling change in urine albumin-to-creatinine ratio from baseline to months 4-24. Safety outcomes included treatment-emergent adverse events and incident hyperkalemia.

resultsOf 12,990 patients, 108 had a history of nephrectomy at baseline; 101 of 108 had radical nephrectomy, 55 received finerenone, and 53 received placebo. Baseline mean eGFR were numerically lower in patients with a history of nephrectomy (48±17 ml/min per 1.73 m 2 ) than in patients without (58±22 ml/min per 1.73 m 2 ). For patients with a history of nephrectomy, those who received finerenone had a greater urine albumin-to-creatinine ratio reduction at 4 months versus those who received placebo (least-squares mean ratio to baseline, 0.65 versus 1.09; least-squares mean treatment ratio, 0.60; 95% confidence interval, 0.48 to 0.76; P < 0.001). This reduction was maintained for 2 years. Treatment-emergent adverse events were similar in patients with and without a history of nephrectomy. Among patients with a history of nephrectomy, treatment-emergent hyperkalemia occurred in 7% and 6% of finerenone and placebo groups, respectively.

conclusionsFinerenone reduced albuminuria compared with placebo and demonstrated a safety profile consistent with the overall FIDELITY population in patients with and without a history of nephrectomy at baseline. Finerenone may delay CKD progression and associated morbidity in patients with CKD and T2D, irrespective of nephrectomy status. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: FIDELIO-DKD ( NCT02540993 ); FIGARO-DKD ( NCT02545049 ).

Indexed as

AlbuminuriaDiabetes Mellitus, Type 2Diabetic NephropathiesMineralocorticoid Receptor AntagonistsNaphthyridinesNephrectomyRenal Insufficiency, ChronicAgedDisease ProgressionFemaleHumansHyperkalemiaMaleMiddle AgedTreatment OutcomefinerenoneMineralocorticoid Receptor AntagonistsNaphthyridineschronic kidney failureCKDdiabetesdiabetic kidney diseasekidney diseasekidney dysfunctionnephrectomyprogression of renal failure

Identifiers

PMID41533467
PMCPMC12959748

What Socratic holds

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LicenceCC BY
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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.