A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)

Inclusion Criteria:

1. Male or female 2 years to <18 years of age at time of consent

2. 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

3. Has Chronic Kidney Disease defined as one of the following:

1. on chronic hemodialysis;

2. receiving chronic peritoneal dialysis;

3. estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2;

4. has evidence of structural and/or functional abnormalities e.g., persistent
albuminuria, abnormal urine sediment, electrolyte and other abnormalities due to
tubular disorders for > 3 months.

4. For patients other than hemodialysis dependent CKD patients, documented history of
unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom
oral iron is considered medically inappropriate

5. All subjects (female and male) of childbearing potential who are sexually active must
be on an effective method of birth control for at least 1 month prior to Day 1 Dosing
and agree to remain on birth control until completion of the study

Exclusion Criteria:

1. Known hypersensitivity reaction to any component of ferumoxytol and iron sucrose

2. History of allergy to intravenous (IV) iron

3. History of multiple drug allergies (>2)

4. Low systolic blood pressure (Age 1-9 years <70 + [age in years x 2] mmHg, Age 10-17
years <90 mmHg)

5. Hemoglobin ≤7.0 g/dL

6. Serum ferritin level >600 ng/mL