Safety and Tolerability of a Single Dose of FCM vs. 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 Hgb indicative of anemia ≤12 g/dL * Screening Visit ferritin indicative of iron deficiency anemia ≤100 ng/mL or ≤300 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 requiring general anesthesia 30 days prior to screening or during the study period * AST of 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 able to use an effective form of birth control