A 6-month multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and PK/PD of an age-and body weight-adjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children, 6 months to <18 years of age, with chronic kidney disease and proteinuria
FIONA: FInerenone for the treatment of children with chrOnic kidNey disease and proteinuriA
What is the goal of the study?
Finerenone has been demonstrated to be safe and efficacious in reducing proteinuria and decreasing the risk for renal events like kidney failure, a sustained decrease in eGFR of 40% or more from baseline, or renal death, as well as cardiovascular events in a high risk population of adults with CKD and T2D. This study is part of an agreed PIP in the condition ‘treatment of chronic kidney disease’. The study aim is to demonstrate that finerenone in addition to an ACEI or ARB is safe and efficacious in reducing urinary protein excretion as a modifiable risk factor for worsening renal function in children with CKD and severely increased proteinuria. This study will include pediatric participants with CKD of different etiologies and severely increased proteinuria at risk for renal function decline. The study will be a 6-month multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and PK/PD of an age-and body weight-adjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of pediatric patients, 6 months to <18 years of age, with ckd and severely increased proteinuria (upcr ≥0.50 g g). participants who fulfill all eligibility criteria will be randomized in a 2:1 ratio to receive finerenone or placebo, in addition to standard of care: finerenone 10 mg od or 20mg od, or respective body weight-adjusted equivalent doses placebo>
Who can participate in the study?
Everyone