FInerenone for the treatment of children with chrOnic kidNey disease and proteinuriA

A 6-month, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and PK/PD of an age- and bodyweight-adjusted oral finerenone regimen, as an adjunct to an ACEI or ARB, for the treatment of children aged 6 months <to <18 years.

ACEI or ARB, for the treatment of children aged 6 months to <18 years with chronic kidney disease and proteinuria.<

Finerenone has been shown to be safe and effective in reducing proteinuria and decreasing the risk of renal events, such as renal failure, and cardiovascular events in high-risk populations with chronic kidney disease (CKD) and type 2 diabetes mellitus (T2D).

The objective of the study is to demonstrate that Finerenone, in addition to an ACEI or an ARB, is safe and effective in reducing urinary protein excretion which represents a modifiable risk factor for worsening renal function in children with CKD and severely increased proteinuria.

The extension study, FIONA OLE, will be an 18-month, single-arm, open-label, multicenter study to evaluate the long-term safety and efficacy of an age- and body weight-adjusted oral finerenone regimen, as an adjunct to an ACEI or an ARB, for the treatment of pediatric and young adult patients, aged 1 <to <19 years, with CKD stages 1-3. Only patients who have completed the double-blind FIONA study will be eligible for inclusion in the FIONA OLE study.

The main aim of the study is to provide data on the long-term safety of Finerenone in the treatment of pediatric and young adult patients with CKD.