Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia

A Multi-center, Randomized, Controlled Study to Investigate the Safety and Tolerability of Intravenous Ferric Carboxymaltose (FCM) vs. Standard Medical Care in Treating Iron Deficiency Anemia

The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.

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