Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care 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 * Screening Visit central laboratory Hemoglobin (Hgb) ≤ 11g/dL * Screening Visit ferritin ≤ 100ng/mL or ≤ 300 ng/mL when TSAT was ≤ 30% Exclusion Criteria: * Previous participation in a FCM trial * Known hypersensitivity reaction to FCM * 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 * AST or ALT greater than 1.5 times the upper limit of normal * Received an investigational drug within 30 days of screening * Pregnant or sexually-active females who are not willing to use an effective form of birth control