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