Evidence map›Paper›PMID 35700142›Full record

ArticleNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2023

Design of the COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with chronic kidney disease and type 2 diabetes using a UACR Endpoint study (CONFIDENCE).

Jennifer B Green, Amy K Mottl, George Bakris, Hiddo J L Heerspink, Johannes F E Mann, Janet B McGill, Masaomi Nangaku, Peter Rossing, Charlie Scott, Alain Gay and 1 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2023. 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 86 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
86citing papers in PubMed, 5 pooled it
20.1field-weighted citation impact, top 1% of its field
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
NCT07434791 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

GOaL Directed-STrategic Approach With New Disease-modifying theraApies to Reduce Kidney and Cardiovascular Risk in Patients With Diabetic Kidney Disease

TypeinterventionalSponsorSunnybrook Health Sciences CentreRan2026 to 2029Enrolled100ConditionsDiabetic Kidney Disease (DKD)ArmsEarly goal-directed Cardio-Kidney-Metabolic (CKM) care, Standard care (Comparison arm)
3 · Its place in the literature

Who cites it

86 citing papers in PubMed, 5 syntheses or guidelines pooled it, 152 citations in OpenAlex.

  1. Pooled it
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  8. Simultaneous initiation of finerenone and empagliflozin across the spectrum of kidney risk in the CONFIDENCE trial.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
    Trial
  9. Trial
  10. COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with chronic kidney disease and type 2 diabetes using a UACR Endpoint (CONFIDENCE) trial: baseline clinical characteristics.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025 · on this map
    Trial
  11. Sodium-Glucose Cotransporter 2 Inhibitors in Patients with Primary Aldosteronism.Clinical journal of the American Society of Nephrology : CJASN · 2026
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26 more citing papers are in PubMed but not listed here.

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 at 10 institutions in 6 countries.

Jennifer B GreenDuke University School of Medicine and Duke Clinical Research Institute, Durham, NC, USA.
Amy K MottlDivision of Nephrology and Hypertension, University of North Carolina Kidney Center, UNC School of Medicine, Chapel Hill, NC, USA.
George BakrisUniversity of Chicago Medicine, Chicago, IL, USA.
Hiddo J L HeerspinkDepartment of Clinical Pharmacy and Pharmacology, University of Groningen University Medical Centre Groningen, Groningen, The Netherlands.
Johannes F E MannKfH Kidney Centre, Munich, Germany, and Friedrich Alexander University, Erlangen, Germany.
Janet B McGillDivision of Endocrinology, Metabolism and Lipid Research, Washington University in St. Louis, School of Medicine, St. Louis, MO, USA.
Masaomi NangakuUniversity of Tokyo Graduate School of Medicine, Tokyo, Japan.
Peter RossingSteno Diabetes Centre Copenhagen, Gentofte, Denmark.
Charlie ScottData Science and Analytics, Bayer PLC, Reading, UK.
Alain GayMedical Affairs & Pharmacovigilance, Pharmaceuticals, Bayer AG, Berlin, Germany.
Rajiv AgarwalRichard L. Roudebush VA Medical Center and Indiana University, Indianapolis, IN, USA.
Bayer (Germany) · DEBayer (United Kingdom) · GBDuke University · USRichard L. Roudebush VA Medical Center · USThe University of Tokyo · JPUniversity of Chicago · USUniversity of Copenhagen · DKUniversity of Groningen · NLUniversity of North Carolina at Chapel Hill · USWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite available interventions, people with type 2 diabetes (T2D) remain at risk of chronic kidney disease (CKD). Finerenone, a potent and selective nonsteroidal mineralocorticoid receptor antagonist, and sodium-glucose cotransporter 2 inhibitors (SGLT2is) can reduce both kidney and cardiovascular risks in people with CKD and T2D. Here we outline the design of a study to investigate whether dual therapy with finerenone and an SGLT2i is superior to either agent alone.

methodsCONFIDENCE (NCT05254002) is a randomized, controlled, double-blind, double-dummy, international, multicenter, three-armed, parallel-group, 7.5 - to 8.5-month, Phase 2 study in 807 adults with T2D, stage 2-3 CKD and a urine albumin:creatinine ratio (UACR) ≥300-<5000 mg/g. The primary objective is to demonstrate that 6 months of dual therapy comprising finerenone and the SGLT2i empagliflozin is superior for reducing albuminuria versus either agent alone. Interventions will be once-daily finerenone 10 mg or 20 mg (target dose) plus empagliflozin 10 mg, or empagliflozin 10 mg alone, or finerenone 10 mg or 20 mg (target dose) alone.

resultsThe primary outcome is a relative change from baseline in UACR among the three groups. Secondary outcomes will further characterize efficacy and safety, including changes in estimated glomerular filtration rate and incident hyperkalemia.

conclusionsCONFIDENCE is evaluating the safety, tolerability and efficacy of dual use of finerenone and an SGLT2i in adults with CKD and T2D. Should an additive effect be shown, early and efficient intervention with dual finerenone and SGLT2i therapy could slow disease progression and provide long-term benefits for people with CKD and T2D.

Indexed as

Diabetes Mellitus, Type 2Diabetic NephropathiesRenal Insufficiency, ChronicBenzhydryl CompoundsClinical Trials, Phase II as TopicGlucosidesHumansMulticenter Studies as TopicNaphthyridinesRandomized Controlled Trials as TopicBenzhydryl CompoundsempagliflozinfinerenoneGlucosidesNaphthyridineschronic kidney diseasediabetesempagliflozinfinerenonemacroalbuminuria

Identifiers

PMID35700142
PMCPMC10064838
OpenAlexW4282925091

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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 OpenQuestion graph.