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Trial of fenelidone in renal failure

Among patients with diabetes, those with kidney disease are associated with extremely high rates of cardiovascular (CV) morbidity and mortality, as well as progression of their underlying disease. Finelidone, a novel, nonsteroidal, selective mineralocorticoid receptor antagonist, has been shown to reduce proteinuria in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD) while showing only a low risk of hyperkalemia.

The nonsteroidal selective mineralocorticoid receptor antagonist fenelidone reduced proteinuria in short-term trials involving patients with chronic kidney disease (CKD) and type 2 diabetes. In a double-blind trial (NCT02540993), 5734 patients with CKD and type 2 diabetes were randomly assigned in a 1:1 ratio to receive or placebo.

Eligible patients had a urine albumin to creatinine ratio (albumin in milligrams, creatinine in grams) of 30 to less than 300, an estimated glomerular filtration rate (eGFR) of 25 to less than 60 ml/min/1.73 m2 of body surface area, and diabetic retinopathy, or they had a urine albumin to creatinine ratio of 300 to 5000 and an eGFR of 25 to less than 75 ml/min/1.73 m2.

The primary composite outcome assessed in the time-to-event analysis was renal failure, sustained eGFR decline of at least 40% from baseline, or death from renal causes. The key secondary composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure was also assessed in the time-to-event analysis.

The effect of fenelidone in the treatment of renal failure

The trial results showed that during a median follow-up of 2.6 years, 504 of 2833 patients (17.8%) in the fenelidone group and 600 of 2841 patients (21.1%) in the placebo group experienced a primary outcome event (hazard ratio 0.82). Key secondary outcome events occurred in 367 patients (13.0%) and 420 patients (14.8%) in each group (hazard ratio, 0.86). Overall, the frequency of adverse events was similar in both groups. The incidence of protocol discontinuations related to hyperkalemia was higher with fenelidone compared with placebo (2.3% and 0.9%, respectively).

Conclusions: In patients with CKD and type 2 diabetes, treatment with fenelidone reduces the risk of CKD progression and cardiovascular events compared with placebo.

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References

Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Nowack C, Schloemer P, Joseph A, Filippatos G; FIDELIO-DKD Investigators. Effect of finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: 10.1056/NEJMoa2025845. Epub 2020 Oct 23. PMID: 33264825.