Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia
This study has been completed.
Information provided by:
First received: June 20, 2008
Last updated: February 23, 2011
Last verified: February 2011
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Luitpold Pharmaceuticals:
Primary Outcome Measures:
- Safety and Tolerability [ Time Frame: Days 7, 14, 28, and 42 ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2008|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
|Experimental: Ferric Carboxymaltose (FCM)||
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.
|Active Comparator: Iron Dextran||
Drug: Iron Dextran
As determined by the investigator to a maximum cumulative dose of 2,250 mg.
Other Name: Dexferrum
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