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Table 1 FIONA key eligibility criteria

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

Inclusion criteria

Exclusion criteria

Age 6 months to < 18 years

Planned urological surgery expected to influence kidney function or scheduled renal transplant within the study time frame

 

Systemic hypertension (stage 2 as defined by the institutional guidelines on BP management

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

CKD stages 1–3a (eGFR ≥ 30 mL/min/1.73 m2) for children aged ≥ 1 year to < 18 years or serum creatinineb ≤ 0.40 mg/dL for infants aged 6 months to < 1 year

Children with hemolytic uremic syndrome diagnosed ≤ 6 months prior to screening

Participants on high dose glucocorticoids, cyclophosphamide, or biological therapies (rituximab and abatacept) within < 6 months prior to screening

Proteinuria defined as UPCR of ≥ 0.50 g/g in patients aged ≥ 2 years with CKD stage 2 or 3, or UPCR ≥ 1.0 g/g for patients aged < 2 years or ≥ 2 years with CKD stage 1

Patients with nephrotic syndrome receiving albumin infusions or with acute kidney injury requiring dialysis within the last 6 months prior to screening

On a maximum tolerated dose of RAASi

Concomitant therapy with an MRA, renin inhibitor, SGLT2i, ARNI, or potassium-sparing diuretic within 30 days prior to screening

Serum [K+] ≤ 5.0 mmol/L for children ≥ 2 years old and ≤ 5.3 mmol/L for children < 2 years old

Concomitant therapy with both ACEi and ARBs together

Concomitant therapy with strong CYP3A4 inhibitors, or moderate or strong CYP3A4 inducers within 7 days prior to randomization

  1. 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, IV Intravenous, [K+] Potassium, MRA Mineralocorticoid receptor antagonist, RAASi Renin–angiotensin–aldosterone system inhibitor, SGLT2i Sodium/glucose cotransporter-2 inhibitor, UPCR Urinary protein-to-creatinine ratio
  2. aCKD stage 1 defined as eGFR ≥ 90 mL/min/1.73 m2; CKD stage 2 defined as eGFR ≥ 60 to < 90 mL/min/1.73 m2; and CKD stage 3 defined as eGFR ≥ 30 to < 60 mL/min/1.73 m2. Patients must have a stable kidney function between screening and baseline, defined as no increase or decrease in eGFR ≥ 15% for children ≥ 1 to > 18 years of age
  3. bPatients must have a stable kidney function between screening and baseline, defined as no increase or decrease in creatinine ≥ 0.10 mg/dL for children aged < 1 year
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ISSN: 1745-6215