10 July 2020 - - A Phase III study FIDELIO-DKD, which is evaluating the efficacy and safety of finerenone versus placebo when added to standard of care for chronic kidney disease in patients with type 2 diabetes, has met its primary endpoint, German pharmaceutical and life science company Bayer (OTC: BAYZF) said.

The results show that the investigational drug finerenone delayed the progression of CKD by reducing the combined risk of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate greater than or equal to 40% from baseline over a period of at least four weeks, or renal death.

Finerenone also reduced the risk of the key secondary endpoint, a composite of time to first occurrence of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or heart failure hospitalization.

The clinical data from FIDELIO-DKD will be presented at an upcoming scientific meeting.

The FIDELIO-DKD study is part of the largest Phase III clinical trial program to date in CKD, which enrolled 13,000 patients across a broad range of disease severity, including those with early kidney damage and more advanced stages of kidney disease.

FIDELIO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study investigating finerenone versus placebo in patients with CKD and T2D.

The study included approximately 5,700 patients from more than 1,000 sites across 48 countries worldwide.

Patients were randomised to receive either finerenone 10 mg or 20 mg orally once daily or placebo when added to standard of care, including blood glucose lowering therapies and maximum tolerated dose of renin–angiotensin system -blocking therapy, such as angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers.

There has been a recent uptick of both federal initiatives and public-private partnerships encouraging innovation to improve kidney health in America.

In 2019, the United States Department of Health and Human Services announced Advancing American Kidney Health, an executive order focused on improving the prevention, detection and treatment of kidney disease.

Finerenone (BAY 94-8862) is an investigational, non-steroidal, selective mineralocorticoid receptor antagonist that has been shown to reduce the harmful effects of mineralocorticoid receptor overactivation.4 Mineralocorticoid receptor overactivation is a major driver of kidney and heart damage.

The finerenone Phase III clinical program is comprised of two studies which randomized more than 13,000 patients with CKD and T2D from around the world to evaluate the effect of finerenone versus placebo on top of standard of care on both renal and CV outcomes.

FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5,700 patients with CKD and T2D. The study has met its primary efficacy endpoint.

FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease) is still ongoing and is investigating the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of CV morbidity and mortality in approximately 7,400 patients with CKD and T2D across 48 countries including sites in Europe, Japan, China and the US In 2015, the US Food and Drug Administration granted Fast Track designation for finerenone.

Bayer also recently announced the initiation of the FINEARTS-HF study, a multicenter, randomized, double-blind, placebo-controlled Phase III study which will investigate finerenone compared to placebo in more than 5,500 symptomatic heart failure patients (New York Heart Association class II-IV) with a left ventricular ejection fraction of greater than or equal to 40%.

The primary objective of the study is to demonstrate superiority of finerenone over placebo in reducing the rate of the composite endpoint of CV death and total (first and recurrent) heart failure events (defined as hospitalizations for HF or urgent HF visits).

Chronic kidney disease is one of the most frequent complications arising from diabetes and is also an independent risk factor of CV.

Approximately 40% of all patients with T2D develop CKD.2 Chronic kidney disease in T2D is the main cause of end stage kidney disease and kidney failure and at advanced stages, patients may need dialysis or a kidney transplant to stay alive.

Over a 10-year period, patients with CKD in T2D were three times more likely to die of CV-related causes than patients with T2D alone.8 Mineralocorticoid receptor over-activation is known to trigger detrimental processes (e.g., inflammation and fibrosis) in the kidneys and heart in patients with CKD and T2D.9 Chronic kidney disease in T2D is the most common cause of kidney failure worldwide.