Conditions: Iron Deficiency Anemia Impaired Renal Function
Keywords: IDA
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2561
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg arm 2: 5 doses of 200 mg for a total cumulative dose of 1000 mg

Interventions: intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Iron Sucrose (Venofer)
Intervention descriptions: intervention 1: 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg intervention 2: 5 doses of 200 mg for a total cumulative dose of 1000 mg

Protocol document: