NCT00982007

Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)

A Multi-center, Randomized, Active Controlled Study to Investigate the Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 997 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to oral iron.

Conditions

• Iron Deficiency Anemia

Interventions

Type	Name	Description
DRUG	Ferric Carboxymaltose (FCM)	A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
DRUG	Ferrous Sulfate Tablets	325 mg Ferrous Sulfate tablets taken orally three times a day
DRUG	IV Iron (standard of care)	IV standard of care (other IV iron) per the Investigator's discretion
DRUG	Ferric Carboxymaltose (FCM)	A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-03-01
• Completion: 2011-08-01
• First posted: 2009-09-22
• Last updated: 2018-02-20
• Results posted: 2013-10-18

Locations

1 site across 1 country: United States