drugset
drugset / Trial / NCT00981045

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

NCT00981045 ↗

Phase 3 Completed 2561 enrolled American Regent, Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2009-08
Primary completion
2011-07
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferric carboxymaltose Other / unclassified 15 mg/kg Intravenous
Comparator Iron sucrose Unknown 200 mg Intravenous

Indications

impaired renal function disease iron deficiency anemia