Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia

Inclusion Criteria:

- Subjects ≥18 years of age and able to give informed consent

- Iron deficiency is the primary etiology of anemia

- History of intolerance or an unsatisfactory response to oral iron

- Screening Visit central laboratory Hgb ≤11 g/dL

- Screening Visit ferritin ≤100 ng/mL or ≤300 when TSAT was ≤30%

Exclusion Criteria:

- Previous participation in a FCM trial

- Known hypersensitivity reaction to FCM or iron dextran

- Requires dialysis for treatment of chronic kidney disease

- Current anemia not attributed to iron deficiency

- Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the
screening phase

- Anticipated need for surgery during the 30 day period prior to screening or during the
study period

- AST or ALT greater than 1.5 times the upper limit of normal

- Received an investigational drug within 30 days of screening

- Women who are breastfeeding

- Pregnant or sexually-active females who are not willing to use an effective form of
birth control