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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

No Placebo-Only Group

Pivotal Trial

All Individual Drugs Already Approved

Approved for 5 Other Conditions

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:

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I have chronic kidney disease or require regular dialysis.

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My child's blood pressure is below the recommended level for their age.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 49 days

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

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

0 / 4Eligibility criteria met