A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
Key facts
- Who runs it
- AMAG Pharmaceuticals, Inc.
- Where
- Buford, Gainesville, Little Rock, Miami, and San Antonio, United StatesSee the 6 sitesAlso in 2 other countries, 3 sites
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 75 people, planned
- Started
- 18 Sept 2019
- Planned end
- Oct 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- ferumoxytol
- Iron sucrose
- Record updated
- 17 April 2026
Who can take part
- Age
- 2 years to 17 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Male or female 2 years to <18 years of age at time of consent
- Has IDA defined as:; Hemoglobin (Hgb) <11.0 g/dL AND; Any one or more of the following:; Transferrin saturation (TSAT) <20%; ferritin <100 ng/mL
- Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate
Who cannot take part
- Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose
- History of allergy to intravenous (IV) iron
- History of ≥2 clinically significant drug allergies
- Subjects with CKD (defined as eGFR of <60 mL/min/1.73 m2 or a requirement for chronic hemodialysis or peritoneal dialysis during Screening)
- Hgb ≤7.0 g/dL
- Serum ferritin level >600 ng/mL
- Low systolic blood pressure (BP) (age 1 to 9 years <70 + [age in years x 2] mmHg, age 10 to 17 years <90 mmHg)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 17 years old?
Where in United States
Also in 2 other countries, 3 sites
- Gwinnett Research InstituteBuford, United StatesContact: Clinical Trial InterestNot yet recruiting
- University of FloridaGainesville, United StatesContact: Clinical Trial InterestNot yet recruiting
- Arkansas Children's HospitalLittle Rock, United StatesContact: Clinical Trial InterestNot yet recruiting
- Biomedical Research LLCMiami, United StatesContact: Clinical Trial InterestTaking people
- Optimus U CorporationMiami, United StatesContact: Clinical Trial InterestTaking people
- Sun Research InstituteSan Antonio, United StatesContact: Clinical Trial InterestTaking people
About the trial
What the trial wants to find out
This is a Phase 3, randomized, open-label, multicenter, study in male and female pediatric subjects (2 years to <18 years of age) with IDA, or felt by their clinician to be at risk of developing IDA. This study allows for enrollment of subjects with IDA regardless of etiology, except for CKD subjects (pediatric CKD subjects are being studied in a separate ferumoxytol protocol).
The 2 groups in the trial
- FerumoxytolTreatment being tested
Each 20 mL single-use vial contains 17 mL of ferumoxytol that consists of iron at a concentration of 30 mg Fe/mL, coated with polyglucose sorbitol carboxymethylether and formulated with mannitol, at a concentration of 44 mg/mL, in a black to reddish brown sterile, aqueous, colloidal, isotonic solution.
- Iron sucroseExisting treatment, for comparison
Each mL contains 20 mg of elemental iron as iron sucrose in water for injection. The 5 mL single-use vial contains 100 mg of iron per 5 mL. The drug product contains approximately 30% sucrose (300 mg/mL)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
- Fit questions
- Built from NCT03893045, who can take part
- Record updated
- 17 April 2026