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

Completed · Phase 3

Conditions studied: Anemia

In brief

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

Key facts

Study ID

NCT00548691

Run by

American Regent, Inc.

People needed

513

Starts

2007-10-01

Expected to finish

2009-07-01

Last updated by the study team

2018-02-20

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Luitpold Pharmaceuticals — Norristown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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