This is a Phase 3, randomized, open-label, multicenter, study in male and female pediatric subjects (2 years to \<18 years of age) with IDA, or felt by their clinician to be at risk of developing IDA. This study allows for enrollment of subjects with IDA regardless of etiology, except for CKD subjects (pediatric CKD subjects are being studied in a separate ferumoxytol protocol).
Male or female 2 years to <18 years of age at time of consent
Hemoglobin (Hgb) <11.0 g/dL AND
Transferrin saturation (TSAT) <20%
ferritin <100 ng/mL
Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose
History of allergy to intravenous (IV) iron
History of ≥2 clinically significant drug allergies
Subjects with CKD (defined as eGFR of <60 mL/min/1.73 m2 or a requirement for chronic hemodialysis or peritoneal dialysis during Screening)