Date: 2015-08-31
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Bayer Healthcare (Germany)
Product: finerenone (BAY 94-8862)
Action
mechanism: mineralocorticoid receptor antagonist (MRA). Finerenone (BAY 94-8862) is a novel potent and selective oral non-steroidal mineralocorticoid receptor antagonist (MRA) blocking deleterious effects of mineralocorticoid receptor (MR) over-activation by aldosterone. Increased activation of the MR leads to pathological changes in the heart and kidneys, which can be prevented by effective blockade of the MR. Current steroidal MRAs on the market have proven to be effective in reducing cardiovascular mortality in patients suffering from heart failure with reduced ejection fraction (HFrEF). However, they are often underutilized due to the incidence of hyperkalemia, renal dysfunction, and anti-androgenic / progestogenic side effects. Finerenone, a third-generation MRA, has demonstrated a promising efficacy and safety profile in preclinical studies as well as in Phase I and Phase II clinical trials.
Disease: diabetic kidney disease
Therapeutic area: Kidney diseases - Metabolic diseases - Renal diseases
Country: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Lithuania, Netherlands, New Zealand, Norway, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, Turkey, UK, USA
Trial
details: FIDELIO-DKD : The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo. (NCT02540993)
Latest
news: * On August 31, 2015, Bayer HealthCare announced the expansion of the clinical development programme for its novel, oral, non-steroidal mineralocorticoid receptor antagonist (MRA) finerenone (BAY 94-8862) with three Phase III studies. The studies will investigate the efficacy and safety of finerenone in patients with chronic heart failure (CHF) and patients with diabetic kidney disease (DKD) with the first patients expected to be enrolled by the year-end. The initiation of the Phase III FINESSE-HF study in chronic heart failure is based on promising data from the exploratory Phase IIb ARTS-HF study, which was presented in a Hot Line Session at ESC Congress 2015 in London. ARTS-HF investigated the effects of different finerenone dosages compared to eplerenone in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF) and type 2 diabetes mellitus and/or chronic kidney disease. Finerenone showed a reduction of surrogate marker NT-proBNP comparable to highly effective eplerenone when comparing Day 90 to baseline while demonstrating meaningful reductions in key exploratory endpoints of all-cause death and cardiovascular hospitalization versus eplerenone with the lowest incidence observed in the finerenone 10/20 mg dose group. All doses of finerenone were well-tolerated and incidences of treatment-emergent adverse events (TEAEs) were similar between eplerenone and all finerenone dose groups. ARTS-HF involved a total of 1,055 patients across 25 countries. The planned Phase III study, FINESSE-HF, will investigate finerenone compared to eplerenone in more than 3,600 chronic heart failure patients with reduced ejection fraction and type 2 diabetes mellitus and/or chronic kidney disease across more than 35 countries including Europe, Japan, China and the US. Patients will receive finerenone or eplerenone on top of standard medical treatment currently represented by angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blocker (ARBs) and β-blockers. The initiation of the Phase III studies FIGARO-DKD and FIDELIO-DKD in diabetic kidney disease is based on promising data from the Phase IIb ARTS-DN study, which was presented at the World Congress of Nephrology (WCN) in March this year. ARTS-DN included 823 patients with type 2 diabetes and the clinical diagnosis of diabetic kidney disease from 23 countries, who were treated for 90 days. The addition of once-daily oral finerenone to RAS-blocking therapy resulted in a significant reduction of albuminuria without adversely affecting serum potassium or kidney function compared with placebo on top of RAS-blocking therapy. All finerenone doses were well-tolerated and incidences of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were comparable between all finerenone treatment groups and standard therapy. The Phase III programme in DKD comprises two studies. FIGARO-DKD will investigate finerenone versus placebo in 6,400 patients with the clinical diagnosis of diabetic kidney disease mainly comprising of patients with high albuminuria (previously known as ‘micro-albuminuria’, defined as Urine Albumin-to-Creatinine Ratio (UACR) ≥ 30mg/g and < 300mg/g) while FIDELIO-DKD will investigate finerenone in comparison to placebo in 4,800 patients with the clinical diagnosis of diabetic kidney disease mainly comprising of patients with very high albuminuria (previously known as ‘macro-albuminuria’, defined as UACR ≥ 300mg/g). Both studies will be conducted in about 40 countries including Europe, Japan, China and the U.S. Patients will receive finerenone or placebo on top of current standard of care, which includes RAS-blocking therapy such as ACE inhibitors or ARBs.
