ASN's Mission

To create a world without kidney diseases, the ASN Alliance for Kidney Health elevates care by educating and informing, driving breakthroughs and innovation, and advocating for policies that create transformative changes in kidney medicine throughout the world.

learn more

Contact ASN

1401 H St, NW, Ste 900, Washington, DC 20005

email@asn-online.org

202-640-4660

The Latest on Twitter

Kidney Week

Abstract: TH-PO974

Efficacy and Safety of Finerenone in Patients With an Acute Change in Estimated Glomerular Filtration Rate: FIDELITY Analysis

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Navaneethan, Sankar D., Baylor College of Medicine, Houston, Texas, United States
  • Agarwal, Rajiv, Richard L Roudebush VA Medical Center, Indianapolis, Indiana, United States
  • Anker, Stefan D., German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany
  • Bakris, George L., The University of Chicago Medicine, Chicago, Illinois, United States
  • Filippatos, Gerasimos, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece
  • Pitt, Bertram, University of Michigan School of Medicine, Ann Arbor, Michigan, United States
  • Rossing, Peter, Steno Diabetes Center Copenhagen, Herlev, Denmark
  • Ruilope, Luis M., Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain
  • August, Phyllis, Weill Cornell Medicine, New York, New York, United States
  • Jardine, Alan G., University of Glasgow, Glasgow, Glasgow, United Kingdom
  • Sarafidis, Pantelis, University of Thessaloniki, Thessaloniki, Greece
  • Brinker, Meike Daniela, Bayer AG, Wuppertal, Nordrhein-Westfalen, Germany
  • Lage, Andrea Zacouteguy, Bayer SA, São Paulo, Brazil
  • Roberts, Luke, Bayer plc, Reading, Berkshire, United Kingdom
  • Scott, Charlie, Bayer plc, Reading, Berkshire, United Kingdom

Group or Team Name

  • On behalf of the FIDELIO-DKD and FIGARO-DKD Investigators
Background

Renin–angiotensin–aldosterone blocker use is associated with an acute decline in estimated glomerular filtration rate (eGFR). This pooled, post hoc analysis of FIDELIO-DKD and FIGARO-DKD trial data assesses the efficacy and safety of finerenone, a distinct, nonsteroidal mineralocorticoid receptor antagonist in patients who sustained an acute change in eGFR upon drug initiation.

Methods

Patients (N=13,171) with type 2 diabetes (T2D), eGFR ≥25 ml/min/1.73 m2, and albuminuria, on optimized renin–angiotensin system blockade were randomized to finerenone or placebo. Risks of composite cardiovascular (CV) (CV death, nonfatal myocardial infarction, nonfatal stroke, or heart failure hospitalization) and composite kidney (kidney failure, sustained eGFR decrease ≥57%, or renal death) outcomes were analyzed by eGFR change (>10% decline, 0–10% decline, 0–10% increase, >10% increase) from baseline to month 1. Safety was assessed by investigator-reported adverse events (AEs).

Results

Of 12,834 patients, 24.7%, 33.8%, 23.5%, and 16.6% had a >10% eGFR decline, 0–10% decline, 0–10% increase, and >10% increase in eGFR, respectively. Finerenone consistently reduced the risk of CV and kidney outcomes irrespective of percentage eGFR change to month 1 (pinteraction=0.60 and 0.35, respectively; Figure 1). Treatment-emergent AEs were similar across subgroups.

Conclusion

The efficacy and safety of finerenone in reducing CV and kidney outcomes were not modified by eGFR change at month 1.

Funding

  • Commercial Support