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

Table 4 FIONA OLE study objectives and endpoints

Objectives	Endpoints
FIONA OLE
Primary
• To demonstrate that finerenone in addition to an ACEi or ARB is safe when given long term	• Number of participants with TEAEs
	• Change in serum K⁺ levels from baseline to day 540 ± 7
	• Change in SBP from baseline to day 540 ± 7
Secondary
• To assess the long-term treatment effects of finerenone in addition to SoC on proteinuria and kidney function	• Change in UPCR and UACR from baseline to day 540 ± 7
	• Change in eGFR from baseline to day 540 ± 7

ACEi Angiotensin-converting enzyme inhibitors, ARB Angiotensin receptor blocker, eGFR estimated glomerular filtration rate, K⁺ Potassium, 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

ISSN: 1745-6215