Investigating the use of finerenone in children with chronic kidney disease and proteinuria: design of the FIONA and open-label extension studies

Table 2 FIONA study objectives and endpoints

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 ± 7^a
	• Percent change from baseline in UPCR to day 180 ± 7^a
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 ± 7^a
	• Percent change in UPCR from baseline to day 180 ± 7^a
• To confirm the dose and systemic exposure of finerenone in children with CKD	• Percent change in UPCR from baseline to day 180 ± 7^a
	• Change in UACR from baseline to day 180 ± 7
• To assess the acceptability and palatability of the pediatric formulation	• PK (finerenone C_max,md, AUC_t,md) based on total concentrations in plasma
	• Taste and texture of the pediatric formulation

ACEi Angiotensin-converting enzyme inhibitors, ARB Angiotensin receptor blocker, AUC_t,md Area under the curve for time after multiple doses, CKD Chronic kidney disease, C_max,md Maximum observed drug concentration after multiple doses, eGFR estimated glomerular filtration rate, K⁺ Potassium, PK Pharmacokinetics, SBP Systolic blood pressure, SoC Standard of care, TEAE Treatment-emergent adverse event, UACR Urinary albumin-to-creatinine ratio, UPCR Urinary protein-to-creatinine ratio
^aThese two primary endpoints are not considered as co-primary endpoints and the respective other endpoint is considered as a secondary endpoint

ISSN: 1745-6215