A clinical trial to study the safety and efficacy of Ferumoxytol for the episodic treatment of Iron Deficiency Anemia

A Phase III, Open-Label Extension Trial of the Safety and Efficacy of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001462

Enrollment

600

Registered

2011-01-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- The study population will consist of subjects who have completed study AMAG-FER-IDA-301

Interventions

Intervention1: Ferumoxytol: IV injection of ferumoxytol 510 mg (17 mL) at Day 1 with a second dose 2 to 8 days after Dose 1, for a total cumulative dose of 1.0 g. Subjects will be monitored for IDA on

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects who have completed participation in study AMAG-FER-IDA-301 2. Female subjects 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

Exclusion criteria

Exclusion criteria: 1. Experienced an SAE related to ferumoxytol in study AMAG-FER-IDA-301 2. Female subjects who are pregnant, intend to become pregnant, are breastfeeding, or have a positive serum/urine pregnancy test

Design outcomes

Primary

Measure	Time frame
Hemoglobin changesTimepoint: 5 week	—

Secondary

Measure	Time frame
Patient reported outcomesTimepoint: 5 week	—

Countries

Canada, India, United States of America

Contacts

Public ContactJohn Luke

Sr. Clinical Research Physician

Sushant.Sehrawat@iconplc.com91-44-43903047

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026