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Iron Supplement

Ferumoxytol for Iron-Deficiency Anemia in Children

Phase 3
Recruiting
Research Sponsored by AMAG Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has IDA defined as: Hemoglobin (Hgb) <11.0 g/dL AND any one or more of the following: Transferrin saturation (TSAT) <20%, ferritin <100 ng/mL, Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate
Male or female 2 years to <18 years of age at time of consent
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 49 days
Awards & highlights

Summary

This trial studies iron deficiency anemia in children 2-18yrs old, regardless of cause, except for those with chronic kidney disease.

Who is the study for?
This trial is for children and teenagers aged 2 to less than 18 with Iron Deficiency Anemia (IDA). They must have low hemoglobin levels, iron saturation, or ferritin, or not tolerate oral iron well. Kids with severe allergies to IV iron, certain hypersensitivities, very low blood pressure, extremely low hemoglobin or chronic kidney disease are excluded.
What is being tested?
The study tests Ferumoxytol against Iron sucrose in treating IDA in young patients. It's a Phase 3 trial where participants are chosen randomly and the process is open for researchers and participants to know which treatment they receive.
What are the potential side effects?
Possible side effects include allergic reactions to the IV iron treatments. Since specific side effects aren't listed here, it's important for parents/guardians to discuss potential risks with the study providers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have iron deficiency anemia with specific blood test results and issues with oral iron.
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I am between 2 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have chronic kidney disease or require regular dialysis.
Select...
My child's blood pressure is below the recommended level for their age.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~49 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 49 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Hemoglobin from Baseline to Week 5
Secondary study objectives
Incidence of Treatment Emergent Adverse Events
Incidence of adverse events of special interest (AESI)
Other study objectives
Area Under the Curve (AUC)
Clearance
Distribution
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: FerumoxytolExperimental Treatment1 Intervention
Each 20 mL single-use vial contains 17 mL of ferumoxytol that consists of iron at a concentration of 30 mg Fe/mL, coated with polyglucose sorbitol carboxymethylether and formulated with mannitol, at a concentration of 44 mg/mL, in a black to reddish brown sterile, aqueous, colloidal, isotonic solution.
Group II: Iron sucroseActive Control1 Intervention
Each mL contains 20 mg of elemental iron as iron sucrose in water for injection. The 5 mL single-use vial contains 100 mg of iron per 5 mL. The drug product contains approximately 30% sucrose (300 mg/mL)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferumoxytol
FDA approved

Find a Location

Who is running the clinical trial?

AMAG Pharmaceuticals, Inc.Lead Sponsor
43 Previous Clinical Trials
11,239 Total Patients Enrolled

Media Library

ferumoxytol (Iron Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03893045 — Phase 3
Iron-Deficiency Anemia Research Study Groups: Ferumoxytol, Iron sucrose
Iron-Deficiency Anemia Clinical Trial 2023: ferumoxytol Highlights & Side Effects. Trial Name: NCT03893045 — Phase 3
ferumoxytol (Iron Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03893045 — Phase 3
~10 spots leftby Jul 2025
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