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Kidney Week

Abstract: SA-OR21

Finerenone and Kidney Outcomes in Patients with CKD and Type 2 Diabetes: Results from FIGARO-DKD

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Bakris, George L., Department of Medicine, University of Chicago Medicine, Chicago, Illinois, United States
  • Ruilope, Luis M., Cardiorenal Translational Laboratory and Hypertension Unit, Madrid, Spain
  • Rossing, Peter, Steno Diabetes Center Copenhagen, Gentofte, Denmark
  • 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
  • Filippatos, Gerasimos, National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens, Greece
  • Mentenich, Nicole, Statistics and Data Insights, Bayer AG, Wuppertal, Germany
  • Lage, Andrea Zacouteguy, Cardiology and Nephrology Clinical Development, Bayer SA, São Paulo, Brazil
  • Scheerer, Markus, Medical Affairs & Pharmacovigilance, Pharmaceuticals, Bayer AG, Berlin, Germany
  • 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

In the FIDELIO-DKD trial, finerenone reduced the risk of kidney outcomes in patients with predominantly advanced chronic kidney disease (CKD) and type 2 diabetes (T2D). FIGARO-DKD investigated the effects of finerenone in patients with less advanced CKD and T2D. The primary outcome of FIGARO-DKD was a cardiovascular composite; here we report the secondary kidney outcomes.

Methods

FIGARO-DKD (NCT02545049) was a randomized, double-blind, placebo-controlled phase III trial. Patients with T2D, 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 ≥60 mL/min/1.73 m2, optimized renin–angiotensin system blockade, and screening serum potassium ≤4.8 mEq/L were randomized to finerenone or placebo. The key secondary kidney outcome was an eGFR 40% composite of time to kidney failure, sustained ≥40% eGFR decline from baseline, or renal death. Another similar kidney composite endpoint, exchanging a sustained ≥40% eGFR decrease with a ≥57% decrease, and change in UACR from baseline to month 4 were pre-specified outcomes in the hierarchical testing strategy.

Results

In the 7352 patients included in the analysis, 62% of patients had baseline eGFR ≥60 mL/min/1.73 m2 and 49% had baseline UACR <300 mg/g. Over a median follow-up of 3.4 years, 350 (9.5%) patients treated with finerenone and 395 (10.8%) patients with placebo had a 40% eGFR composite endpoint event (hazard ratio [HR]=0.87, 95% confidence interval [CI] 0.76–1.01; p=0.069). There was a clinically meaningful prolongation of the time to the 57% eGFR composite endpoint with finerenone (HR=0.77, 95% CI 0.60–0.99). Greater reduction in UACR at month 4 was observed with finerenone (ratio of least-squares means 0.68, 95% CI 0.65–0.70). Overall, the incidence of adverse events were similar between treatment arms.

Conclusion

In FIGARO-DKD, patients with stage 1–4 CKD and T2D, finerenone induced a pronounced reduction in albuminuria. Kidney composite outcomes observed were directionally similar to that seen among patients with more advanced kidney disease in the FIDELIO-DKD trial.

Funding

  • Commercial Support