Evidence map›Paper›PMID 40021271›Full record

ArticleJACC. Advances2025

Finerenone Efficacy in Patients with Chronic Kidney Disease, Type 2 Diabetes, and Anemia in FIDELITY.

Ajay K Singh, Glen James, Stefan D Anker, Bertram Pitt, Peter Rossing, Luis M Ruilope, Alfredo E Farjat, Youssef M K Farag, Luke Roberts, Gerasimos Filippatos and 1 more

2 registry-linked trialsAbstract read
In one paragraph

Article in JACC. Advances, 2025. 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Article
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

11 authors.

Ajay K SinghRenal Division, Brigham and Women's Hospital, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA. Electronic address: Ajay_Singh@hms.harvard.edu.
Glen JamesIntegrated Evidence Generation and Business Innovation, Bayer PLC, Reading, United Kingdom.
Stefan D AnkerDepartment of Cardiology (CVK) of German Heart Center Charité, Institute of Health Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany; Institute of Heart Diseases, Wrocław Medical University, Wrocław, Poland.
Bertram PittDepartment of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan, USA.
Peter RossingSteno Diabetes Center Copenhagen, Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Luis M RuilopeCardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain; CIBER-CV, Hospital Universitario 12 de Octubre, Madrid, Spain; Faculty of Sport Sciences, European University of Madrid, Madrid, Spain.
Alfredo E FarjatResearch and Development, Clinical Data Sciences and Analytics, Bayer PLC, Reading, United Kingdom.
Youssef M K FaragPostgraduate Medical Education, Harvard Medical School, Boston, Massachusetts, USA; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Luke RobertsClinical Development, Bayer PLC, Reading, United Kingdom.
Gerasimos FilippatosNational and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens, Greece.
FIDELIO-DKD and FIGARO-DKD Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnemia is common in patients with chronic kidney disease and type 2 diabetes. Finerenone improved heart and kidney outcomes in patients with chronic kidney disease and type 2 diabetes in FIDELITY.

objectivesThis post hoc analysis investigated the efficacy and safety of finerenone vs placebo by baseline anemia status.

methodsAnemia was defined as serum hemoglobin levels <13 g/dL (male) or <12 g/dL (female) or treatment with an erythropoiesis-stimulating agent at baseline. Outcomes included cardiovascular (CV) and kidney composites, hospitalization for heart failure, and all-cause mortality. Safety was assessed through treatment-emergent adverse events.

resultsOf 12,971 patients, 33% had anemia at baseline. Finerenone reduced the risk of the CV composite outcome to a greater extent in patients with vs without anemia (HR: 0.75 [95% CI: 0.65-0.88] vs HR: 0.93 [95% CI: 0.82-1.05]; P for interaction = 0.03). Finerenone reduced the risk of the kidney composite outcome vs placebo, with no heterogeneity between patients with vs without anemia (HR: 0.79 [95% CI: 0.65-0.95] and HR: 0.74 [95% CI: 0.60-0.91]; P for interaction = 0.77). The risk of hospitalization for heart failure and all-cause mortality was lower with finerenone vs placebo, irrespective of anemia status. Patients with anemia experienced higher incidence of treatment-emergent hyperkalemia vs those without.

conclusionsFinerenone demonstrated CV and kidney benefit in patients with and without anemia. The benefit of finerenone on CV outcomes was greater in patients with vs without anemia at baseline. Anemia is likely a marker for higher-risk patients who are more susceptible to the benefits of finerenone. (Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease [FIDELIO-DKD], NCT02540993; Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease [FIGARO-DKD], NCT02545049).

Indexed as

all-cause mortalityanemiachronic kidney diseasefinerenonehospitalization for heart failuretype 2 diabetes

Identifiers

PMID40021271
PMCPMC11905162

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.