RecruitingPhase 3

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

United States75 participantsStarted 2019-09-18

Plain-language summary

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).

Who can participate

Age range2 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
✓. 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

What they're measuring

Change in Hemoglobin from Baseline to Week 5

Timeframe: 35 days

Trial details

NCT IDNCT03893045

SponsorAMAG Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Clinical Trial Interest

1-877-374 -4177 CTInterest@covispharma.com

View on ClinicalTrials.gov More Iron Deficiency Anemia trials