Bayer extends clinical development program for finerenone with Phase III study in children and adolescents.

The primary objective of the study is to demonstrate superiority of finerenone in addition to an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) over placebo in reducing urine protein excretion in these patients. The primary outcome measure is the change in urine protein creatinine ratio (UPCR) from baseline to 6 months.

“Chronic kidney disease is a rare but devastating condition affecting children across the age spectrum. Despite some progress achieved through previous research efforts, children with this condition continue to experience disease progression and proteinuria – an important, modifiable risk factor for kidney function decline. New treatments are needed to target this risk factor whilst working synergistically with current therapies,” said Dr. Franz Schaefer, Professor of Pediatrics and Chief of the Pediatric Nephrology Division at Heidelberg University Hospital. “If successful, insights from this study could be of great significance to children living with chronic kidney disease and their families.”

Proteinuria is an important modifiable risk factor for CKD progression in children. Aldosterone-mediated activation of mineralocorticoid receptors (MR) in the kidney drive the downward spiral by promoting tissue inflammation and injury. Finerenone is an investigational, non-steroidal, selective MR antagonist that in preclinical studies has been shown to block harmful effects of MR overactivation, which is thought to contribute to CKD progression and cardiovascular damage.

Finerenone has been investigated in a broad population of adult patients with stages 1-4 CKD and type 2 diabetes (T2D) across two completed Phase III studies: FIDELIO-DKD and FIGARO-DKD. In these studies, finerenone demonstrated benefits on kidney and cardiovascular outcomes in patients with CKD and T2D. Finerenone demonstrated a consistent safety profile across studies. FIDELITY, a pre-specified pooled analysis of the FIDELIO-DKD and FIGARO-DKD studies to evaluate the occurrence of progression of kidney disease as well as fatal and nonfatal CV events in more than 13,000 patients with CKD and T2D, evaluated the potential benefit of finerenone across the disease spectrum.

The planned Phase III FIONA study will investigate finerenone compared to placebo in addition to standard of care in approximately 200 patients with CKD. Patients will be randomized in a 2:1 ratio to receive either a body-weight adjusted dose of finerenone or placebo on top of individually optimized labeled doses of either ACE inhibitors or an ARB. The FIONA study will contribute to the IMI2 conect4children (c4c) project, by utilising the c4c network and its clinical sites across Europe. c4c aims to provide better medicines for babies, children and young people by improving the way clinical trials are planned and conducted across Europe. In addition, the study will be conducted in collaboration with two pediatric CKD-specific clinical research networks, ESCAPE (European Study Consortium for Chronic Kidney Disorders affecting Pediatric Patients) and NAPRTCS (North-American Pediatric Renal Trials and Collaborative Studies).

In July, finerenone was approved under the brand name Kerendia by the FDA based on the positive results of the FIDELIO-DKD Phase III study for adult patients with CKD and T2D. Finerenone has also been submitted for marketing authorization in the European Union (EU) and China, as well as multiple other countries worldwide; these applications are currently under review.