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



Status:Not yet recruiting
Conditions:Iron Deficiency Anemia, Anemia, Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:2 - 17
Updated:3/30/2019
Start Date:May 2019
End Date:October 2020
Contact:Clinical Trial Interest
Email:AMAGCT@druginfo.com
Phone:1-877-233-4781

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Trial Summary
Trial Overview
Inclusion Criteria

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

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).


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
We found this trial at
1
site
AMAG Pharmaceuticals, Inc.
Waltham, Massachusetts 02451
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mi
from
Waltham, MA
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