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
• History of intolerance or an unsatisfactory response to oral iron
• Screening Visit central laboratory Hgb ≤11 g/dL
• Screening Visit ferritin ≤100 ng/mL or ≤300 when TSAT was ≤30%

Exclusion Criteria:

• Previous participation in a FCM trial
• Known hypersensitivity reaction to FCM or iron dextran
• 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 during the 30 day period prior to screening or during the study period
• AST or ALT greater than 1.5 times the upper limit of normal
• Received an investigational drug within 30 days of screening
• Women who are breastfeeding
• Pregnant or sexually-active females who are not willing to use an effective form of birth control

Safety population

1 year