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