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

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

Who can join

Ages 2 to 17 · All sexes

Inclusion Criteria:

1. Male or female 2 years to \<18 years of age at time of consent
2. Has IDA defined as:

   1. Hemoglobin (Hgb) \<11.0 g/dL AND
   2. Any one or more of the following:

      * 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

Exclusion Criteria:

1. Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose
2. History of allergy to intravenous (IV) iron
3. History of ≥2 clinically significant drug allergies
4. Subjects with CKD (defined as eGFR of \<60 mL/min/1.73 m2 or a requirement for chronic hemodialysis or peritoneal dialysis during Screening)
5. Low systolic blood pressure (BP) (age 1 to 9 years \<70 + \[age in years x 2\] mmHg, age 10 to 17 years \<90 mmHg)
6. Hgb ≤7.0 g/dL
7. Serum ferritin level \>600 ng/mL

About the study

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).

What is being tested

• ferumoxytol (drug)
• Iron sucrose (drug)

Sponsor: AMAG Pharmaceuticals, Inc. · Participants: 75 · Started: Sep 18, 2019

Contact the study team

• Clinical Trial Interest · Phone: 1-877-374 -4177

Official record on ClinicalTrials.gov — NCT03893045

Locations in the U.S.

Conditions

• Iron-Deficiency Anemia
• Anemia

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.