A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
AMAG Pharmaceuticals, Inc. · NCT03893045
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 2–17 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 75
- US sites recruiting
- 3
- Study start
- September 18, 2019
- Record last updated
- April 17, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: ferumoxytol; Iron sucrose
Conditions: Iron Deficiency Anemia
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
- Low systolic blood pressure (BP) (age 1 to 9 years \<70 + [age in years x 2] mmHg, age 10 to 17 years \<90 mmHg)
- Hgb ≤7.0 g/dL
- Serum ferritin level >600 ng/mL
Recruiting US locations
Optimus U Corporation
Miami, FL 33125
Biomedical Research LLC
Miami, FL 33184
Sun Research Institute
San Antonio, TX 78215
Study contacts (from the official record)
- Clinical Trial Interest · 1-877-374 -4177 · CTInterest@covispharma.com