Conditions: Iron Deficiency Anemia (IDA)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1025
Healthy volunteers: no

Brief summary:
The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy or to IV iron therapy.

Detailed description:
The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy for 28 days or to IV iron therapy.

Arms:
arm 1: 2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg. arm 2: At a dose and administration regimen as determined by the study site investigator

Interventions: intervention 1: Injectafer intervention 2: SOC
Intervention descriptions: intervention 1: 2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg. intervention 2: None

Protocol document: