A Phase III, Randomized, Double-Blind, Placebo Controlled Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia

Inclusion Criteria

Key Inclusion Criteria include:

1. Males and females ≥18 years of age

2. Subjects with IDA

3. Subjects who have a history of unsatisfactory oral iron therapy or in whom oral iron
cannot be used

4. Female subjects of childbearing potential who are sexually active must be on an
effective method of birth control for at least 1 month prior to screening and agree
to remain on birth control until completion of participation in the study

Key Exclusion Criteria include:

1. History of allergy to IV iron

2. Allergy to two or more classes of drugs

3. Subjects on dialysis or with an estimated glomerular filtration rate (eGFR) <30
mL/min/1.73m2

4. Female subjects who are pregnant, intend to become pregnant, are breastfeeding,
within 2 weeks postpartum, or have a positive serum/urine pregnancy test

5. Hemoglobin ≤7.0 g/dL

6. Serum ferritin >600 ng/mL