Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia
This study has been completed.
Information provided by (Responsible Party):
First received: June 20, 2008
Last updated: September 16, 2013
Last verified: September 2013
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.
Drug: Ferric Carboxymaltose (FCM)
Drug: Standard Medical Care (SMC) for the treatment of IDA
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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. Standard Medical Care 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, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC [ Time Frame: First administration of FCM, or Day 0 for SMC subjects, through end of study (Day 42) or 28 days after the last dose of study drug (FCM or SMC) whichever was longer ] [ Designated as safety issue: Yes ]Safety, as defined by the occurence of serious adverse events (SAE's), of FCM compared to SMC in the treatment of IDA in subjects who were not dialysis dependent
|Study Start Date:||July 2008|
|Study Completion Date:||March 2011|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Experimental: Ferric Carboxymaltose (FCM)
750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).
|Drug: Ferric Carboxymaltose (FCM)|
Active Comparator: Standard Medical Care (SMC) for the treatment of IDA
SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
|Drug: Standard Medical Care (SMC) for the treatment of IDA|
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