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


The Latest on Twitter

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


  • 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

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.


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.


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.


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.


  • Commercial Support