Kidney Week

Abstract: FR-OR51

Effect of Finerenone on CKD Outcomes in Type 2 Diabetes

Session Information

• High-Impact Clinical Trials
  October 23, 2020 | Location: Live-Streamed
  Abstract Time: 10:30 AM - 10:45 AM

Category: Diabetic Kidney Disease

• 602 Diabetic Kidney Disease: Clinical

Authors

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

George L. Bakris, MD, MA, FASN

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

Rajiv Agarwal,

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

Stefan D. Anker,

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

Bertram Pitt,

• Ruilope, Luis M., Institute of Research imas12, Madrid, Spain

Luis M. Ruilope,

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

Peter Rossing,

• Kolkhof, Peter, Bayer AG, Wuppertal, Germany

Peter Kolkhof,

• Nowack, Christina, Bayer AG, Wuppertal, Germany

Christina Nowack,

• Schloemer, Patrick, Bayer AG, Berlin, Germany

Patrick Schloemer,

• Joseph, Amer, Bayer AG, Berlin, Germany

Amer Joseph,

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

Gerasimos Filippatos,

Group or Team Name

• on behalf of the FIDELIO-DKD Investigators

Background

Patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) remain at risk of CKD progression despite guideline-directed therapies. Mineralocorticoid receptor (MR) overactivation may drive CKD progression through inflammatory and fibrotic processes. Finerenone, a novel, nonsteroidal MR antagonist, reduces albuminuria independent of hemodynamic effects. We assessed the long-term efficacy and safety of finerenone in slowing CKD progression in patients with CKD and T2D.

Methods

This global, phase 3, double-blind study randomized 5734 patients from 48 countries (1:1) to oral finerenone or placebo. Patients with T2D, urine albumin-to-creatinine ratio 30–5000 mg/g and estimated glomerular filtration rate (eGFR) 25–<75 mL/min/1.73 m², treated with optimized renin–angiotensin system blockade, were included. The primary outcome was time to kidney failure, sustained eGFR decline ≥40% from baseline or renal death. The key secondary outcome was time to cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke or heart failure hospitalization. (NCT02540993)

Results

Mean patient age was 65.6 years; 70.2% were male. At baseline, mean eGFR was 44.3 mL/min/1.73 m² and median UACR 852 mg/g. The primary outcome occurred in 504/2833 (17.8%) and 600/2841 (21.1%) patients treated with finerenone and placebo, respectively (hazard ratio [HR]=0.82; 95% confidence interval [CI] 0.73–0.93; p=0.0014). The prespecified secondary outcome was also reduced with finerenone (13.0%) vs placebo (14.8%; HR=0.86; 95% CI 0.75–0.99, p=0.0339). Overall treatment-emergent adverse events were balanced between groups. The incidence of hyperkalemia-related treatment discontinuation was higher with finerenone than placebo (2.3% and 0.9%, respectively).

Conclusion

Finerenone significantly reduced kidney and CV outcomes in patients with T2D and advanced CKD and was well tolerated. While the primary adverse event was hyperkalemia, it only necessitated treatment discontinuation in 2.3% of patients compared to 0.9% in placebo. These data support the use of finerenone to slow CKD progression and reduce CV risk in patients with CKD and T2D.

Funding

• Commercial Support – Bayer AG