Objectives | Endpoints |
---|---|
FIONA | |
Primary | |
 • To demonstrate that finerenone in addition to an ACEi or ARB is superior to placebo in reducing urinary protein excretion | • UPCR reduction of at least 30% from baseline to day 180 ± 7a |
• Percent change from baseline in UPCR to day 180 ± 7a | |
Secondary | |
 • To assess the safety profile of finerenone in addition to SoC in children with CKD compared with placebo | • Number of participants with TEAEs |
• Change in serum K+, serum creatinine, eGFR, and SBP from baseline to day 180 ± 7 | |
 • To further support the efficacy of finerenone in addition to SoC in children with CKD | |
• UPCR reduction of at least 30% from baseline to day 180 ± 7a | |
• Percent change in UPCR from baseline to day 180 ± 7a | |
 • To confirm the dose and systemic exposure of finerenone in children with CKD | |
• Change in UACR from baseline to day 180 ± 7 | |
 • To assess the acceptability and palatability of the pediatric formulation | • PK (finerenone Cmax,md, AUCt,md) based on total concentrations in plasma |
• Taste and texture of the pediatric formulation |