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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Regent, Inc.; Luitpold Pharmaceuticals
• Treatments: Ferric Compounds

Criteria

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