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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

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

Criteria

Inclusion Criteria:

• Male or Female 18 to 85 years of age

• NDD-CKD Patients

• TSAT
• Hgb
• Ferritin
• HD-CKD Patients

• TSAT
• Hgb
• Ferritin 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