What is ferumoxytol studying for iron deficiency anemia in children?

Ferumoxytol is being studied to understand its safety, effectiveness, and how the body processes it in treating iron deficiency anemia in children aged 2 to 17 years. The study compares ferumoxytol to another iron treatment, iron sucrose, to gather important information. This research is sponsored by AMAG Pharmaceuticals, Inc.

Who may be eligible for this iron deficiency anemia clinical trial?

Children aged 2 to under 18 years with iron deficiency anemia or at risk for it may be eligible. Both males and females can join. Important factors include low hemoglobin levels, iron measures, and previous issues with oral iron therapy. Please review eligibility criteria for more details.

Is there any cost to participate in this iron deficiency anemia clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses to the study site may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 3

Age: 2Years - 17Years

All Genders

ID03893045

Phase 3 Study of Ferumoxytol Versus Iron Sucrose for Treating Iron Deficiency Anemia in Children Aged 2 to Under 18 Years

Led by AMAG Pharmaceuticals, Inc. · Updated on 2026-04-17

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the safety, effectiveness, and how the body processes ferumoxytol for treating iron deficiency anemia IDA in children aged 2 to under 18 years. The study includes male and female pediatric subjects with IDA or those considered at risk of developing IDA by their clinician, regardless of cause, except for those with chronic kidney disease CKD, who are studied separately. Participants will be randomly assigned in a 21 ratio to receive either ferumoxytol or iron sucrose. Ferumoxytol is given as two intravenous doses of 7 mg iron per kg, with a maximum of 510 mg per dose the first dose is on Day 1 and the second dose is 2 to 8 days later. Iron sucrose is given as five intravenous doses of 4 mg iron per kg, with a maximum of 200 mg per dose the first dose is on Day 1 and the remaining doses are given at least once per week and up to three times per week. Participants are monitored for one hour after each infusion. Throughout the study, which lasts up to 5 weeks, researchers will assess hemoglobin levels, check for side effects or adverse events, and perform other safety tests. The main outcome measured is the change in hemoglobin from the start to Week 5. Additional safety assessments include tracking any new or special adverse events up to 49 days after treatment begins.

CONDITIONS

Brief Title

A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects

Who Can Participate

Age: 2Years - 17Years

All Genders

Eligibility Criteria

You may qualify if you...

Male or female aged 2 years to under 18 years at time of consent
Has iron deficiency anemia defined by hemoglobin less than 11.0 g/dL and at least one of the following: transferrin saturation less than 20% or ferritin less than 100 ng/mL
Documented history of unsatisfactory oral iron therapy or unable to tolerate oral iron, or oral iron is medically inappropriate

You will not qualify if you...

Known allergy to any component of ferumoxytol or iron sucrose
History of allergy to intravenous iron
History of two or more clinically significant drug allergies
Chronic kidney disease defined as eGFR less than 60 mL/min/1.73 m2 or need for chronic dialysis
Low systolic blood pressure (under 70 + [age in years x 2] mmHg for ages 1-9; under 90 mmHg for ages 10-17)
Hemoglobin less than 7.0 g/dL
Serum ferritin level above 600 ng/mL

Research Team

Clinical Trial Interest

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here