Safety and Tolerability of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients

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

The Objective of this study is to study the safety of FCM in patients with anemia caused by chronic kidney failure

Inclusion Criteria:

• Male or Female 18 to 85 years of age
• NDD-CKD Patients
• TSAT </= 25%
• Hgb </= 11.5
• Ferritin </= 300
• HD-CKD Patients
• TSAT </= 30%
• Hgb </= 12
• Ferritin </= 500

Exclusion Criteria:

• Previous participation in a FCM trial
• Known Hypersensitivity to FCM
• History of anemia other that anemia due to chronic renal failure
• Current history of GI bleeding
• Received IV Iron within the last 30 Days
• Anticipated need for surgery
• Malignancy history
• AST or ALT greater than 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