Study of Ferumoxytol for Iron Deficiency Anemia in Children

This study is looking at two intravenous (IV) iron treatments, ferumoxytol and iron sucrose, for children aged 2 to 17 years old who have iron deficiency anemia (IDA). IDA means your body doesn't have enough iron to make healthy red blood cells. You might be able to join if you have IDA, defined by a hemoglobin level below 11.0 g/dL and certain iron levels (transferrin saturation below 20% or ferritin below 100 ng/mL), and if oral iron hasn't worked or isn't an option. The main goal is to see how much your hemoglobin levels change from the start of the study to Week 5. The study plans to enroll 75 participants.

Study design
This is a Phase 3, randomized, open-label study, meaning participants are randomly assigned to one of two treatments, and both you and your doctors will know which treatment you receive. About 75 children are expected to participate.
What's involved
You would receive either two doses of ferumoxytol or five doses of iron sucrose intravenously. You would be monitored at the study site for at least one hour after each infusion and have blood tests and safety checks through Week 5.
Compensation
Not stated in the trial record.
Follow-up
Your hemoglobin levels and safety will be monitored through Week 5 after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03893045

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

Recruiting
PHASE3Ages 2–17InterventionalTreatment
AMAG Pharmaceuticals, Inc.
~75 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:ferumoxytolIron sucrose

At a glance

Recruiting sites
3 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Hemoglobin from Baseline to Week 5
Measured over 35 days
Iron Deficiency Anemia

NCT03893045

Where you'd take part

This study runs at 15 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Arkansas Children's Hospital

    Little Rock, Arkansasno site contact published

    Not yet recruiting

  • Biomedical Research LLC

    Miami, Floridano site contact published

    Recruiting

  • Centrum Zdrowia MDM

    Warsaw, Polandno site contact published

    Not yet recruiting

  • Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos

    Vilnius, Lithuaniano site contact published

    Not yet recruiting

  • Gwinnett Research Institute

    Buford, Georgiano site contact published

    Not yet recruiting

  • JSC Saules seimos medicinos centras

    Kaunas, Lithuaniano site contact published

    Not yet recruiting

  • Klaipeda Children's Hospital

    Klaipėda, Lithuaniano site contact published

    Not yet recruiting

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów, Polandno site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

Transferrin saturation (TSAT) \<20%
ferritin \<100 ng/mL 3. Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate
  • Change in Hemoglobin from Baseline to Week 535 days

    Proportion of subjects achieving a change in hemoglobin from Baseline to Week 5