Researchers reported that patients who received finerenone had a lower risk of kidney failure or death from renal causes.
A recent study published in The New England Journal of Medicine reported on the clinically significant benefits of finerenone in patients with chronic kidney disease (CKD) and type 2 diabetes. According to the findings, treatment with finerenone resulted in lower risk of CKD progression and cardiovascular events compared with placebo.
Type 2 diabetes is the leading cause of CKD globally. Investigators explained that, although recommended treatments exist, newer therapies are needed to address CKD.
CKD and diabetes are cardiorenal diseases and research shows that overactivation of the mineralocorticoid receptor through inflammation and fibrosis leads to progressive kidney and cardiovascular dysfunction. However, data on hard clinical outcomes are lacking, according to the study authors.
Finerenone is a nonsteroidal, selective mineralocorticoid receptor antagonist and has demonstrated “more potent anti-inflammatory and antifibrotic effects than steroidal mineralocorticoid receptor antagonists in preclinical models,” the study authors wrote.
Researchers therefore designed the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease (FIDELIO-DKD) trial to evaluate finerenone in its ability to slow CKD progression and reduce cardiovascular morbidity and mortality among patients with advanced CKD and type 2 diabetes.
The phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trial incorporated 5734 patients with CKD and type 2 diabetes, and who had urinary albumin-to-creatinine ratio from 30 to less than 300, an estimated glomerular filtration rate (eGFR) between 25 and ml per minute per 1.73 m2 of body-surface area, and diabetic retinopathy, or who had a urinary albumin-to-creatinine ratio of 300 to 5000 and an eGFR of 25 to ml per minute per 1.73 m2.
Between September 2015 and June 2020, patients in 48 countries were randomized 1:1 to receive either finerenone or placebo, with a primary composite outcome of kidney failure, a sustained decrease of at least 40% in the eGFR from baseline, or death from renal causes. A total of 98.1% and 98.8% of patients were treated with an ACE inhibitor or ARB, respectively. The trial concluded after a median follow-up of 2.6 years.
The incidence of kidney failure, a sustained decrease of at least 40% in the eGFR from baseline, and death from renal causes was significantly lower in the finerenone group than in the placebo group, with 504 patients (17.8%) in the finerenone group and 600 patients (21.1%) in the placebo group. Patients treated with finerenone additionally showed a significantly lower risk of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure, according to investigators; these outcomes occurred in 367 (30%) patients in the finerenone group and 420 patients (14.8%) in the placebo group.
Limitations of the study included the exclusion of patients with nonalbuminuric CKD and CKD not due to type 2 diabetes. In addition, the investigators identified population limitations, as only 4.7% of patients identified as Black.
“These results suggest that in patients with CKD and type 2 diabetes, finerenone may be an effective treatment for kidney and cardiovascular protection,” the study authors concluded.