Conditions: Iron Deficiency Anemia
Keywords: IDA
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 997
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Intravenous (IV) iron arm 2: Oral iron - Ferrous Sulfate tablets arm 3: Other IV iron arm 4: Intravenous (IV) iron

Interventions: intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Ferrous Sulfate Tablets intervention 3: IV Iron (standard of care) intervention 4: Ferric Carboxymaltose (FCM)
Intervention descriptions: intervention 1: A total maximum cumulative dose of 1500 mg administered on Days 0 and 7. intervention 2: 325 mg Ferrous Sulfate tablets taken orally three times a day intervention 3: IV standard of care (other IV iron) per the Investigator's discretion intervention 4: A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.

Protocol document: