Conditions: Iron Deficiency Anemia
Keywords: Iron deficiency anemia Feraheme Ferumoxytol IDA
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 634
Healthy volunteers: no

Brief summary:
To evaluate the safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia (IDA).

Detailed description:

Arms:
arm 1: Participants received ferumoxytol or placebo during AMAG-FER-IDA-301 \[NCT01114139\]. Participants enrolled in AMAG-FER-IDA-303, a 6-month Extension Study, were evaluated monthly and could receive treatment with ferumoxytol only if they met criteria defined as persistent or recurrent IDA, hemoglobin \<11.0 grams per deciliter (g/dL) and transferrin saturation (TSAT) \<20% at any evaluation visit, (except study termination visit). Participants who met criteria began a 5-week treatment period (TP) and received 2 doses of ferumoxytol 510 mg intravenously (IV). The first IV 510-mg dose was administered on TP Day 1 (Baseline); the second 2-8 (5±3) days after Dose 1. The first treatment course with ferumoxytol for participants who previously received placebo in AMAG-FER-IDA-301 was considered Course 1; Course 2 included participants who previously received ferumoxytol in AMAG-FER-IDA-301; subsequent treatment courses were serially numbered.

Interventions: intervention 1: Ferumoxytol
Intervention descriptions: intervention 1: IV Ferumoxytol

Protocol document: