Actively Recruiting
A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
Led by AMAG Pharmaceuticals, Inc. · Updated on 2026-04-17
75
Participants Needed
15
Research Sites
367 weeks
Total Duration
On this page
AI-Summary
What this Trial 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).
CONDITIONS
Official Title
A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 2 years to under 18 years at consent
- Diagnosis of iron deficiency anemia with hemoglobin below 11.0 g/dL and at least one of: transferrin saturation below 20% or ferritin below 100 ng/mL
- History of unsatisfactory oral iron therapy, intolerance to oral iron, or medical inappropriateness for oral iron
You will not qualify if you...
- Known allergy to ferumoxytol or iron sucrose components
- History of allergy to intravenous iron
- History of two or more significant drug allergies
- Chronic kidney disease with eGFR below 60 mL/min/1.73 m2 or requiring dialysis
- Low systolic blood pressure below age-specific thresholds
- Hemoglobin 7.0 g/dL or lower
- Serum ferritin level above 600 ng/mL
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Not Yet Recruiting
2
University of Florida
Gainesville, Florida, United States, 32608
Not Yet Recruiting
3
Optimus U Corporation
Miami, Florida, United States, 33125
Actively Recruiting
4
Biomedical Research LLC
Miami, Florida, United States, 33184
Actively Recruiting
5
Gwinnett Research Institute
Buford, Georgia, United States, 30519
Not Yet Recruiting
6
Sun Research Institute
San Antonio, Texas, United States, 78215
Actively Recruiting
7
JSC Saules seimos medicinos centras
Kaunas, Lithuania
Not Yet Recruiting
8
Klaipeda Children's Hospital
Klaipėda, Lithuania
Not Yet Recruiting
9
Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos
Vilnius, Lithuania
Not Yet Recruiting
10
Osrodek Badan Klinicznych In Vivo sp. z o.o.
Bydgoszcz, Poland
Not Yet Recruiting
11
Prywatny Gabinet Lekarski Dr N. med. Jerzy Brzostek
Dębica, Poland
Not Yet Recruiting
12
Pro Familia Altera Sp. z o.o.
Katowice, Poland
Not Yet Recruiting
13
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Poland
Not Yet Recruiting
14
Centrum Zdrowia MDM
Warsaw, Poland
Not Yet Recruiting
15
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, Poland
Not Yet Recruiting
Research Team
C
Clinical Trial Interest
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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