NCT00704028

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

A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of Intravenous Ferric Carboxymaltose (FCM) vs. Iron Dextran in Treating Iron Deficiency Anemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	Ferric Carboxymaltose	15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
DRUG	Iron Dextran	As determined by the investigator to a maximum cumulative dose of 2,250 mg.

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-01-01
• Completion: 2011-03-01
• First posted: 2008-06-24
• Last updated: 2018-02-20
• Results posted: 2013-11-25

Locations

1 site across 1 country: United States