A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia

• Status: Completed
• Trial end date: 2013-04-23
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AMAG Pharmaceuticals, Inc.
• Treatments: Ferrosoferric Oxide; Iron

Criteria

Key Inclusion Criteria include:

1. Participants who completed participation in study AMAG-FER-IDA-301 [NCT01114139]

2. Female participants of childbearing potential who are sexually active must be on an effective method of birth control and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria include:

1. Experienced a serious adverse event (SAE) related to ferumoxytol in study AMAG-FER-IDA-301

2. Female participants who are pregnant, intend to become pregnant, are breastfeeding, or have a positive serum/urine pregnancy test