Primary Objectives:
To evaluate the safety (compared to iron sucrose) and efficacy of ferumoxytol in pediatric CKD subjects with iron deficiency anemia (IDA) or who are at risk of development of IDA
Secondary Objective:
To determine the single-dose pharmacokinetics (PK) and pharmacodynamics (PD) profile of ferumoxytol in pediatric subjects.
Male or female 2 years to <18 years of age at time of consent
Has IDA defined as: a) hemoglobin <12.0 g/dL and b) with either transferrin saturation (TSAT) <40% or ferritin <100 ng/mL; or considered to be at risk of development of IDA, i.e., TSAT<20% with falling hemoglobin during the preceding 2 months and a history of hemoglobin <12 g/dL
on chronic hemodialysis;
receiving chronic peritoneal dialysis;
Known hypersensitivity reaction to any component of ferumoxytol and iron sucrose
History of allergy to intravenous (IV) iron
History of multiple drug allergies (>2)
Low systolic blood pressure (Age 1-9 years <70 + [age in years x 2] mmHg, Age 10-17 years <90 mmHg)
Parallel
Ferumoxytol
DrugEach 20 mL single-use vial contains 17 mL of ferumoxytol that consists of iron at a concentration of 30 mg Fe/mL, coated with polyglucose sorbitol carboxymethylether and formulated with mannitol, at a concentration of 44 mg/mL, in a black to reddish brown sterile, aqueous, colloidal, isotonic solution.
Iron sucrose
DrugEach mL contains 20 mg of elemental iron as iron sucrose in water for injection. The 5 mL single-use vial contains 100 mg of iron per 5 mL. The drug product contains approximately 30% sucrose (300 mg/mL).
Hemoglobin change of at least 0.5 g/dL from Baseline to Week 5
Proportion of patients achieving a hemoglobin change of at least 0.5 g/dL during the period from Baseline to Week 5
Incidence of Treatment Emergent Adverse Events
Incidence of Treatment Emergent Adverse Events
Incidence of adverse events of special interest (AESI)
Incidence of adverse events of special interest (AESI) (hypotension and hypersensitivity)
Area Under the Curve (AUC)
Pharmacokinetic parameter: Area Under the Curve (AUC)
Clearance
Pharmacokinetic parameter: clearance
Distribution and elimination half-lives
Pharmacokinetic parameter: distribution and elimination half-lives
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