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

• Late-Breaking Clinical Trials (Posters)
  November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
  Abstract Time: 10:00 AM - 12:00 PM

Category: Diabetic Kidney Disease

• 602 Diabetic Kidney Disease: Clinical

Authors

• Navaneethan, Sankar D., Baylor College of Medicine, Houston, Texas, United States

Sankar D. Navaneethan,

• Agarwal, Rajiv, Richard L Roudebush VA Medical Center, Indianapolis, Indiana, United States

Rajiv Agarwal,

• Anker, Stefan D., German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany

Stefan D. Anker,

• Bakris, George L., The University of Chicago Medicine, Chicago, Illinois, United States

George L. Bakris,

• Filippatos, Gerasimos, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece

Gerasimos Filippatos,

• Pitt, Bertram, University of Michigan School of Medicine, Ann Arbor, Michigan, United States

Bertram Pitt,

• Rossing, Peter, Steno Diabetes Center Copenhagen, Herlev, Denmark

Peter Rossing,

• Ruilope, Luis M., Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain

Luis M. Ruilope,

• August, Phyllis, Weill Cornell Medicine, New York, New York, United States

Phyllis August,

• Jardine, Alan G., University of Glasgow, Glasgow, Glasgow, United Kingdom

Alan G. Jardine,

• Sarafidis, Pantelis, University of Thessaloniki, Thessaloniki, Greece

Pantelis Sarafidis,

• Brinker, Meike Daniela, Bayer AG, Wuppertal, Nordrhein-Westfalen, Germany

Meike Daniela Brinker,

• Lage, Andrea Zacouteguy, Bayer SA, São Paulo, Brazil

Andrea Zacouteguy Lage,

• Roberts, Luke, Bayer plc, Reading, Berkshire, United Kingdom

Luke Roberts,

• Scott, Charlie, Bayer plc, Reading, Berkshire, United Kingdom

Charlie Scott,

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 (p_interaction=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 – Bayer AG