Conditions: Anemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 708
Healthy volunteers: no

Brief summary:
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.

Detailed description:

Arms:
arm 1: 750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg). arm 2: SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).

Interventions: intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Standard Medical Care (SMC) for the treatment of IDA
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: