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