Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia

Completed · Phase 3

Conditions studied: Anemia

In brief

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

Key facts

Study ID

NCT00704353

Run by

American Regent, Inc.

People needed

735

Starts

2008-06-01

Expected to finish

2011-03-01

Last updated by the study team

2018-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects ≥18 years of age and able to give informed consent
• Iron deficiency is the primary etiology of anemia
• Screening Visit central laboratory Hgb indicative of anemia ≤12 g/dL
• Screening Visit ferritin indicative of iron deficiency anemia ≤100 ng/mL or ≤300 when TSAT was ≤30%

You may not qualify if…

• 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 requiring general anesthesia 30 days prior to screening or during the study period
• AST of 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 able 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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