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

Table 3 FIONA OLE key eligibility criteria

Inclusion criteria	Exclusion criteria
Age ≥ 1 to < 19 years	Planned urological surgery expected to influence renal function
Prior participation in FIONA study	Patients who are candidates for renal transplantation
CKD stages 1–3 (eGFR ≥ 30 mL/min/1.73 m²) for children aged ≥ 1 year to < 19 years at FIONA EoT and visit 1	Systemic hypertension (stage 2 as defined by the institutional guidelines on BP management
On a maximum tolerated dose of RAASi	Systemic hypotension defined as symptomatic hypotension or a mean systolic BP below the 5th percentile for age, sex, and height but no lower than 80 mmHg for participants < 18 years and symptomatic hypotension or a mean SBP < 90 mmHg in participants ≥ 18 years at visit 1
Serum K⁺ ≤ 5.0 mmol/L for children ≥ 2 years old and ≤ 5.3 mmol/L for children < 2 years old at both FIONA EoT and visit 1	Concomitant therapy with an MRA, any renin inhibitor, any SGLT2i, ARNI or potassium-sparing diuretic
	Concomitant therapy with both ACEi and ARBs together
	Concomitant therapy with strong CYP3A4 inhibitors, moderate or strong CYP3A4 inducers

ACEi Angiotensin-converting enzyme inhibitor, ARB Angiotensin receptor blocker, ARNI Angiotensin receptor neprilysin inhibitor, BP Blood pressure, CKD Chronic kidney disease, CYP3A4 Cytochrome P450 3A4, eGFR estimated glomerular filtration rate, EoT End of treatment, K⁺ Potassium, MRA Mineralocorticoid receptor antagonist, OLE Open label extension, RAASi Renin–angiotensin–aldosterone system inhibitor, SBP Systolic blood pressure, SGLT2i Sodium/glucose cotransporter-2 inhibitor

ISSN: 1745-6215