A Phase IV Trial of Repeated Doses of Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Patients With Chronic Kidney Disease on Hemodialysis

Key Inclusion Criteria include:

1. Males and females ≥18 years of age

2. Diagnosis of CKD

3. Subjects on dialysis must have been on dialysis for at least 3 months prior to
screening

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 either oral or IV iron

2. Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3
months postpartum, or have a positive serum or urine pregnancy test

3. Parenteral iron therapy within 30 days prior to screening or red blood cell
(RBC)/whole blood transfusion within 14 days prior to screening or planned during the
study