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

• Status: Recruiting
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AMAG Pharmaceuticals, Inc.
• Treatments: Ferric Oxide, Saccharated; Ferrosoferric Oxide; Iron

Criteria

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