Evidence map›Paper›PMID 40886054›Full record

Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2025

Simultaneous initiation of finerenone and empagliflozin across the spectrum of kidney risk in the CONFIDENCE trial.

Muthiah Vaduganathan, Jennifer B Green, Hiddo J L Heerspink, Sung Gyun Kim, Johannes F E Mann, Janet B McGill, Amy Mottl, Masaomi Nangaku, Julio Rosenstock, Peter Rossing and 5 more

2 registry-linked trialsAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT05254002. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT05254002 phase2completed

A Parallel-group Treatment, Phase 2, Double-blind, Three-arm Study to Assess Efficacy and Safety of Finerenone Plus Empagliflozin Compared With Either Finerenone or Empagliflozin Alone in Participants With Chronic Kidney Disease and Type 2 Diabetes.

Ran2022Enrolled1,664Registered outcomes22Posted comparisons0ConditionsChronic Kidney Disease, Type 2 Diabetes MellitusArmsempagliflozin, Empagliflozin placebo, Finerenone (BAY94-8862 ) 10 mg, Finerenone (BAY94-8862 ) 20 mg, Finerenone Placebo
Open the trial in the graph
NCT07719621 not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Implication of Albuminuria Reduction and Other Cardiorenal Effects on The Risk of Heart Failure in Patients With CKD and T2D

TypeobservationalSponsorAeterna Medical Solutions SLRan2026 to 2026Enrolled50,000ConditionsCKD - Chronic Kidney Disease, Diabetes Mellitus Type 2
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. 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

15 authors.

Muthiah VaduganathanDivision of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.ORCID 0000-0003-0885-1953
Jennifer B GreenDivision of Endocrinology, Department of Medicine and Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Hiddo J L HeerspinkDepartment Clinical Pharmacy and Pharmacology, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands.ORCID 0000-0002-3126-3730
Sung Gyun KimDivision of Nephrology, Hallym University Sacred Heart Hospital, Anyang, South Korea.
Johannes F E MannKfH (Kuratorium für Dialyse und Nierentransplantation) Kidney Center, Munich, Germany.
Janet B McGillDivision of Endocrinology, Metabolism and Lipid Research, Washington University in St Louis, St Louis, MO, USA.
Amy MottlUniversity of North Carolina (UNC) Kidney Center, UNC School of Medicine, Chapel Hill, NC, USA.
Masaomi NangakuDivision of Nephrology and Endocrinology, The University of Tokyo Graduate School of Medicine, Tokyo, Japan.ORCID 0000-0001-7401-2934
Julio RosenstockVelocity Clinical Research at Medical City, Dallas, TX, USA.ORCID 0000-0001-8324-3275
Peter RossingSteno Diabetes Center Copenhagen and University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-1531-4294
Li LiBayer AG, Berlin, Germany.
Na LiBayer Healthcare, Beijing, China.
Katja RohwedderBayer AG, Berlin, Germany.
Charlie ScottBayer Healthcare Inc., Whippany, NJ, USA.
Rajiv AgarwalDivision of Nephrology, Richard L. Roudebush VA Medical Center, Indianapolis Indiana University School of Medicine, Indianapolis, USA.ORCID 0000-0001-8355-7100

Funding

Bayer AG
6 · The paper itself

Abstract

backgroundThe CONFIDENCE (COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with CKD and type 2 diabetes using a UACR Endpoint) trial investigated the safety and efficacy of simultaneously initiating finerenone and empagliflozin for patients with chronic kidney disease (CKD) and type 2 diabetes. This prespecified analysis aimed to determine if the predicted risk of kidney disease progression, based on KDIGO risk categories, influenced the benefits and safety of this combination therapy.

methodsThe double-blind, double-dummy trial randomized 818 adults with CKD and type 2 diabetes [urine albumin-creatinine ratio (UACR) ≥100 to <5000 mg/g] to receive once-daily finerenone plus empagliflozin, finerenone alone or empagliflozin alone, all in addition to a renin-angiotensin system inhibitor. The relative change in UACR from baseline to day 180 (primary endpoint) and a >30% reduction in UACR (secondary endpoint) across KDIGO risk categories was assessed.

resultsAt baseline, among 781 with available data, 11.3% of participants were classified as low/moderate risk, 29.6% as high risk and 59.2% as very high risk. At 180 days, combination therapy significantly reduced UACR levels across all KDIGO risk categories (low/moderate: -61.7%; high: -60.7%; very high: -52.4%). This reduction was consistently greater than that achieved with either monotherapy alone. More than half of patients on combination therapy experienced UACR reductions of >30% (low/moderate: 58.1%; high: 74.2%; very high: 70.6%), again outperforming monotherapies across all risk groups. While hyperkalemia was more common with combination therapy, early eGFR declines (>30% within 30 days) were less frequent in individuals with higher KDIGO risk compared with lower risk. Overall, the safety profile of combination therapy remained consistent across all KDIGO risk categories, with no unexpected safety signals.

conclusionsThe CONFIDENCE trial demonstrates that the relative efficacy and safety of simultaneous finerenone and empagliflozin combination therapy are consistent across a wide spectrum of predicted kidney disease risk. CLINICAL

trial registrationNCT05254002; EudraCT 2021-003037-11.

Indexed as

Benzhydryl CompoundsDiabetes Mellitus, Type 2GlucosidesNaphthyridinesRenal Insufficiency, ChronicAgedAlbuminuriaDisease ProgressionDouble-Blind MethodDrug Therapy, CombinationFemaleFollow-Up StudiesGlomerular Filtration RateHumansMaleMiddle AgedBenzhydryl CompoundsempagliflozinfinerenoneGlucosidesNaphthyridinesSodium-Glucose Transporter 2 Inhibitorsclinical trialsmineralocorticoid receptor antagonistssodium-glucose co-transporter-2 inhibitors

Identifiers

PMID40886054
PMCPMC12722168

What OpenQuestion 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 OpenQuestion graph.