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.
A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
At a glance
Conditions
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.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
What this trial measures
- Change in Hemoglobin from Baseline to Week 535 days
Proportion of subjects achieving a change in hemoglobin from Baseline to Week 5