NCT00981045

Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function

Randomized Evaluation of Efficacy and Safety of Ferric Carboxymaltose in Patients With Iron Deficiency Anemia and Impaired Renal Function

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,561 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to examine the efficacy and safety (cardiovascular) of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron sucrose (Venofer) in subjects who have iron deficiency anemia (IDA) and impaired renal function.

Conditions

• Iron Deficiency Anemia
• Impaired Renal Function

Interventions

Type	Name	Description
DRUG	Ferric Carboxymaltose (FCM)	2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
DRUG	Iron Sucrose (Venofer)	5 doses of 200 mg for a total cumulative dose of 1000 mg

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-07-01
• 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