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Kidney Week

Abstract: PO2531

Finerenone and Kidney Outcomes in Patients with CKD and T2D: Results from FIDELITY

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Bakris, George L., University of Chicago Medicine Infectious Diseases & Global Health, Chicago, Illinois, United States
  • Ruilope, Luis M., Instituto de Investigacion en Ciencias de la Salud, Madrid, Spain
  • Anker, Stefan D., Charite Universitatsmedizin Berlin - Campus Virchow-Klinikum, Berlin, Berlin, Germany
  • Filippatos, Gerasimos, Ethniko kai Kapodistriako Panepistemio Athenon Iatrike Schole, Athens, Attica, Greece
  • Pitt, Bertram, University of Michigan Medical School, Ann Arbor, Michigan, United States
  • Rossing, Peter, Steno Diabetes Center Copenhagen, Gentofte, Denmark
  • Fried, Linda F., University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States
  • Roy-Chaudhury, Prabir, University of North Carolina School of Medicine Neuroscience Center, Chapel Hill, North Carolina, United States
  • Sarafidis, Pantelis, Aristoteleio Panepistemio Thessalonikes, Thessaloniki, Central Macedonia, Greece
  • Ahlers, Christiane, Bayer AG, Wuppertal, Nordrhein-Westfalen, Germany
  • Joseph, Amer, Bayer AG, Wuppertal, Nordrhein-Westfalen, Germany
  • Brinker, Meike Daniela, Bayer AG, Wuppertal, Nordrhein-Westfalen, Germany
  • Lawatscheck, Robert, Bayer AG, Berlin, Berlin, Germany
  • Agarwal, Rajiv, Indiana University School of Medicine, Indianapolis, Indiana, United States
Background

FIDELITY, a prespecified meta-analysis of FIDELIO-DKD and FIGARO-DKD, evaluates the efficacy and safety of finerenone across a spectrum of patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).

Methods

FIDELITY combines individual patient data from FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049). Eligible patients were adults with T2D and CKD (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 ≥25 mL/min/1.73 m2), treated with optimized renin–angiotensin system blockade. Efficacy outcomes included a composite kidney outcome of time to first onset of kidney failure (end-stage kidney disease [ESKD] or sustained eGFR <15 mL/min/1.73 m2), sustained ≥57% decrease in eGFR from baseline over ≥4 weeks, or renal death.

Results

In 13,026 patients, over 3.0 years’ median follow-up, finerenone reduced the risk of the kidney composite outcome by 23% vs placebo (HR=0.77; 95% CI 0.67–0.88; P=0.0002); consistent benefits were observed across baseline eGFR and UACR subgroups (Pinteraction 0.62 and 0.67, respectively). Compared with placebo, finerenone led to a nominally significant reduction in the incidence of all nonfatal components of the kidney composite outcome, including a 20% lower risk of ESKD (chronic dialysis or kidney transplant; HR=0.80; 95% CI 0.64–0.99; P=0.04). Finerenone caused an initial drop in eGFR vs placebo (least-squares [LS] mean change in eGFR slope from baseline to month 4, –3.3 vs –1.0 mL/min/1.73 m2) but slowed long-term eGFR decline (LS mean change in eGFR slope from month 4 onwards, –2.5 vs –3.7 mL/min/1.73 m2/year). The incidence of adverse events was similar between groups. The incidence of permanent discontinuation due to hyperkalemia in finerenone and placebo recipients with an eGFR <60 mL/min/1.73 m2 was 2.4% and 0.8%, respectively, and 0.6% and 0.3% in those with an eGFR ≥60 mL/min/1.73 m2.

Conclusion

FIDELITY demonstrates robust kidney benefits and safety of finerenone in patients with T2D across the spectrum of CKD severity.

Funding

  • Commercial Support