Actively Recruiting
A Phase 3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Subjects
Led by AMAG Pharmaceuticals, Inc. · Updated on 2026-04-17
75
Participants Needed
15
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety, effectiveness, and how the body processes ferumoxytol for treating iron deficiency anemia (IDA) in children aged 2 to under 18 years. The study includes male and female pediatric subjects with IDA or those considered at risk of developing IDA by their clinician, regardless of cause, except for those with chronic kidney disease (CKD), who are studied separately. Participants will be randomly assigned in a 2:1 ratio to receive either ferumoxytol or iron sucrose. Ferumoxytol is given as two intravenous doses of 7 mg iron per kg, with a maximum of 510 mg per dose; the first dose is on Day 1 and the second dose is 2 to 8 days later. Iron sucrose is given as five intravenous doses of 4 mg iron per kg, with a maximum of 200 mg per dose; the first dose is on Day 1 and the remaining doses are given at least once per week and up to three times per week. Participants are monitored for one hour after each infusion. Throughout the study, which lasts up to 5 weeks, researchers will assess hemoglobin levels, check for side effects or adverse events, and perform other safety tests. The main outcome measured is the change in hemoglobin from the start to Week 5. Additional safety assessments include tracking any new or special adverse events up to 49 days after treatment begins.
CONDITIONS
Brief 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 time of consent
- Has iron deficiency anemia defined by hemoglobin less than 11.0 g/dL and at least one of the following: transferrin saturation less than 20% or ferritin less than 100 ng/mL
- Documented history of unsatisfactory oral iron therapy or unable to tolerate oral iron, or oral iron is medically inappropriate
You will not qualify if you...
- Known allergy to any component of ferumoxytol or iron sucrose
- History of allergy to intravenous iron
- History of two or more clinically significant drug allergies
- Chronic kidney disease defined as eGFR less than 60 mL/min/1.73 m2 or need for chronic dialysis
- Low systolic blood pressure (under 70 + [age in years x 2] mmHg for ages 1-9; under 90 mmHg for ages 10-17)
- Hemoglobin less than 7.0 g/dL
- Serum ferritin level above 600 ng/mL
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 weeks
Participants receive either ferumoxytol with 2 intravenous doses given 2 to 8 days apart, or iron sucrose with up to 5 intravenous doses given once per week or up to 3 times per week. Participants are monitored through at least 1 hour after each infusion, and safety assessments are performed.
Multiple visits for each infusion dose with monitoring after each dose
Duration - Up to 5 weeks from treatment start
Participants are assessed for hemoglobin changes and monitored for adverse events through Week 5 after treatment initiation.
Visits aligned with treatment visits and assessments
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
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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