A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia

The purpose of the study is to evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA).

• Drug: Ferumoxytol
  IV Ferumoxytol
  Other Name: Feraheme
• Drug: Iron Sucrose
  IV Iron Sucrose
  Other Name: Venofer

• Experimental: Ferumoxytol
  Intravenous (IV) iron
  Intervention: Drug: Ferumoxytol
• Active Comparator: Iron Sucrose
  Other intravenous (IV) iron
  Intervention: Drug: Iron Sucrose

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