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