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Kidney Week

Abstract: SA-OR22

Finerenone in Patients with CKD and Type 2 Diabetes by SGLT-2i Treatment: The FIDELITY Analysis

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Rossing, Peter, Steno Diabetes Center Copenhagen, Gentofte, Denmark
  • Filippatos, Gerasimos, National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens, Greece
  • Bakris, George L., Department of Medicine, University of Chicago Medicine, Chicago, Illinois, United States
  • Anker, Stefan D., Department of Cardiology (CVK) and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany
  • Pitt, Bertram, Department of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan, United States
  • Ruilope, Luis M., Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain
  • Gebel, Martin, Research and Development, Pharmaceuticals, Bayer AG, Wuppertal, Germany
  • Scheerer, Markus, Medical Affairs & Pharmacovigilance, Pharmaceuticals, Bayer AG, Berlin, Germany
  • Roberts, Luke, Study Medical Experts, Bayer PLC, Reading, United Kingdom
  • Joseph, Amer, Cardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany
  • Agarwal, Rajiv, Richard L. Roudebush VA Medical Center and Indiana University, Indianapolis, Indiana, United States
Background

The aim of the FIDELITY analysis is to evaluate the efficacy and safety of finerenone, a novel, nonsteroidal, selective mineralocorticoid receptor antagonist, across the spectrum of patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) in the FIDELIO-DKD and FIGARO-DKD trials. Sodium-glucose co-transporter-2 inhibitors (SGLT-2is) are recommended for patients with CKD and T2D to reduce the risk of CKD progression, thus their combined use with finerenone is of interest. We report the pooled FIDELITY analysis of patients by SGLT-2i use.

Methods

This prespecified analysis combines patient-level data from the FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049) phase III, randomized, double-blind, placebo-controlled, multicenter clinical trials. Patients were randomized 1:1 to oral finerenone or placebo. Patients had T2D and either a urine albumin-to-creatinine ratio (UACR) ≥30–<300 mg/g and estimated glomerular filtration rate (eGFR) ≥25–≤90 mL/min/1.73 m2, or UACR ≥300–≤5000 mg/g and eGFR ≥25 mL/min/1.73 m2, with optimized renin–angiotensin system blockade. Efficacy outcomes included a cardiovascular (CV) composite endpoint of time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure, and a kidney composite endpoint of time to kidney failure, sustained ≥40% eGFR decline from baseline, or renal death.

Results

The FIDELITY analysis includes 13,026 patients. Approximately 7% of patients (n=877) received an SGLT-2i at baseline (finerenone: 6.7% [n=438]; placebo: 6.7% [n=439]). Compared with placebo, finerenone reduced the risk of the CV composite endpoint irrespective of SGLT-2i use at baseline (with SGLT-2i: hazard ratio [HR]=0.63, 95% confidence interval [CI] 0.40–<1.00; without SGLT-2i: HR=0.87, 95% CI 0.79–0.96; p-interaction 0.41), additional findings for efficacy outcomes, in addition to overall safety and hyperkalemia-related events by SGLT-2i treatment, will be presented.

Conclusion

FIDELIO-DKD and FIGARO-DKD comprise the largest cardiorenal outcomes program to date; therefore, combining the data for the SGLT2i subgroup in the FIDELITY analysis may provide further insights into the effects of receiving both finerenone and an SGLT-2i.

Funding

  • Commercial Support