Kidney Week

Abstract: PO2531

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

Session Information

• Late-Breaking Clinical Trials Posters
  November 04, 2021 | Location: On-Demand, Virtual Only
  Abstract Time: 10:00 AM - 12:00 PM

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

George L. Bakris,

• Ruilope, Luis M., Instituto de Investigacion en Ciencias de la Salud, Madrid, Spain

Luis M. Ruilope,

• Anker, Stefan D., Charite Universitatsmedizin Berlin - Campus Virchow-Klinikum, Berlin, Berlin, Germany

Stefan D. Anker,

• Filippatos, Gerasimos, Ethniko kai Kapodistriako Panepistemio Athenon Iatrike Schole, Athens, Attica, Greece

Gerasimos Filippatos,

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

Bertram Pitt,

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

Peter Rossing,

• Fried, Linda F., University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States

Linda F. Fried,

• Roy-Chaudhury, Prabir, University of North Carolina School of Medicine Neuroscience Center, Chapel Hill, North Carolina, United States

Prabir Roy-Chaudhury,

• Sarafidis, Pantelis, Aristoteleio Panepistemio Thessalonikes, Thessaloniki, Central Macedonia, Greece

Pantelis Sarafidis,

• Ahlers, Christiane, Bayer AG, Wuppertal, Nordrhein-Westfalen, Germany

Christiane Ahlers,

• Joseph, Amer, Bayer AG, Wuppertal, Nordrhein-Westfalen, Germany

Amer Joseph,

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

Meike Daniela Brinker,

• Lawatscheck, Robert, Bayer AG, Berlin, Berlin, Germany

Robert Lawatscheck,

• Agarwal, Rajiv, Indiana University School of Medicine, Indianapolis, Indiana, United States

Rajiv Agarwal,

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 (P_interaction 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 –