Study Suggests Bayer’s Finerenone Slows CKD Progression in Patients With Kidney Disease and T2D
George L. Bakris, M.D., from the University of Chicago Medicine, pictured above. Photo courtesy of Mr. Bakris.
Findings from a recently published Phase III study show that Bayer’s nonsteroidal antimineralocorticoid drug, finerenone, slowed progression of renal and cardiovascular events better than placebo in patients with chronic kidney disease (CKD) and type two diabetes over a nearly three-year period. The findings from this study were presented at the virtual American Society of Nephrology’s (ASN) Kidney Week 2020 on October 23, and the full study was published in a recent online edition of the New England Journal of Medicine.
While current treatments for patients with CKD and diabetes focus on metabolic and hemodynamic pathways, there is currently a lack of therapies for these patients that can reduce the residual increased risk of kidney disease progression, according to a statement made by leading study research, George L. Bakris, M.D., from the University of Chicago Medicine.
“The findings from FIDELIO-DKD provide important evidence suggesting a potential new strategy for treating these patients,” Bakris said. “Overactivation of the mineralocorticoid receptor contributes to inflammation and fibrosis in the kidneys and heart, which represents an unmet medical need. The results with finerenone are highly relevant for these patients who currently have limited options.”
In the Bayer-funded FIDELIO-DKD trial, a team of investigators from the U.S. and Europe randomized a total of 5,734 patients with CKD and type 2 diabetes to either once-daily oral finerenone at 10 mg or 20 mg or a matching placebo. Patients received renin–angiotensin system blockade adjusted prior to randomization, according to the manufacturer’s label, to the maximum dose not associated with unacceptable side effects.
The primary composite outcome of the trial included kidney failure, a sustained decrease of at least 40% in the eGFR from baseline, or death from renal causes. An additional composite outcome comprised several cardiovascular events, including death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke or hospitalization for heart failure.
Over a median follow-up period of 2.6 years, an event from the primary composite outcome occurred in 17.8% of patients randomized to finerenone versus 21.1% of patients assigned to placebo. According to the investigators, this difference was statistically significant and in favor of finerenone (hazard ratio [HR], 0.82; 95% CI, 0.73-0.93; P=0.001).
In addition, a significantly lower proportion of key secondary outcome events occurred in the finerenone group compared with the placebo arm (13.0 vs. 14.8%, respectively; HR, 0.86; 95% CI, 0.75-0.99; P=0.03). Adverse events (AEs) were generally mild or moderate in severity, and no difference was observed between the two groups in regard to the frequency of AEs.
Also, serious AEs were observed at a lower frequency in patients assigned to finerenone (31.9% vs. 34.3%). In contrast, a greater proportion of patients treated with finerenone discontinued the trial’s treatment regimen because of hyperkalemia (2.3% vs. 0.9%).
“These vulnerable patients need to be protected by delaying the need for dialysis or a kidney transplant and to reduce their risk of cardiovascular events,” added Dr. Joerg Moeller, an executive member of Bayer AG's Pharmaceutical Division and Head of Research and Development. “There is a high unmet medical need in cardiovascular and kidney diseases, which we aim to address with our research and development efforts. The FIDELIO-DKD results demonstrate that finerenone may become a new potential therapeutic option for patients with chronic kidney disease and type 2 diabetes.”
Based on findings from the FIDELIO-DKD trial, Bayer said it will submit a New Drug Application for marketing approval of finerenone in diabetic kidney disease by the end of 2020.