← Back to Search

Iron Supplement

Ferumoxytol for Iron-Deficiency Anemia in Children

Q: What medical conditions is Ferumoxytol frequently utilized to treat?

Ferumoxytol is routinely used for the treatment of oral cavity maladies and can be administered to address iron insufficiency, dietary deficiencies, or as a remedy for anemia.

Q: Could I potentially qualify for this medical investigation?

This medical trial is open to patients between 2 and 17 years old who have been diagnosed with iron-deficiency anemia. 75 individuals will be accepted into the study in total.

Q: Has the FDA given its authorization for Ferumoxytol to be used therapeutically?

Ferumoxytol has been evaluated for safety according to our team at Power, and it earned a score of 3 due to the existence of multiple studies that have demonstrated its efficacy as well as security.

Q: Are adolescents within the age range of this experiment being considered?

This clinical trial is restricted to children aged between 2 and 17. Meanwhile, there are 104 trials recruiting minors and an additional 202 for seniors above the age of 65.

Q: What is the current enrollment for this research project?

In order to initiate the trial, 75 volunteers that meet specified criteria must enroll. Trial sites are located in both Vilnius, <a href="https://www.withpower.com/clinical-trials/florida">Florida</a> and Kaunas, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a>; namely Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos and JSC Saules seimos medicinos centras.

Q: Has Ferumoxytol been studied in any other research settings?

Currently, 25 clinical trials involving Ferumoxytol are in progress with 5 of them now being Phase 3. The primary location for these studies is Buford, <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a> yet a total of 134 other sites have opened to administer this medication to trial participants.

Q: Is recruitment for this research endeavor still in progress?

Affirmative, the information available on clinicaltrials.gov attests to this trial's active recruitment of participants. Initiated on September 18th 2019 and most recently updated in July 25th 2023, it is looking for 75 individuals across 15 distinct locations.

Q: How many research facilities are implementing this trial?

15 clinical trial centres are active for this medical study, such as Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos in Vilnius, JSC Saules seimos medicinos centras in Kaunas, and Optimus U Corporation in Miami; the remaining sites are distributed throughout other locations.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 49 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have iron deficiency anemia with specific blood test results and issues with oral iron.

Select...

I am between 2 and 17 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Hemoglobin from Baseline to Week 5

Secondary outcome measures

Incidence of Treatment Emergent Adverse Events

Incidence of adverse events of special interest (AESI)

Other outcome measures

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AMAG Pharmaceuticals, Inc.Lead Sponsor

43 Previous Clinical Trials

11,291 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions is Ferumoxytol frequently utilized to treat?

"Ferumoxytol is routinely used for the treatment of oral cavity maladies and can be administered to address iron insufficiency, dietary deficiencies, or as a remedy for anemia."

Answered by AI

Could I potentially qualify for this medical investigation?

"This medical trial is open to patients between 2 and 17 years old who have been diagnosed with iron-deficiency anemia. 75 individuals will be accepted into the study in total."

Answered by AI

Has the FDA given its authorization for Ferumoxytol to be used therapeutically?

"Ferumoxytol has been evaluated for safety according to our team at Power, and it earned a score of 3 due to the existence of multiple studies that have demonstrated its efficacy as well as security."

Answered by AI

Are adolescents within the age range of this experiment being considered?

"This clinical trial is restricted to children aged between 2 and 17. Meanwhile, there are 104 trials recruiting minors and an additional 202 for seniors above the age of 65."

Answered by AI

What is the current enrollment for this research project?

"In order to initiate the trial, 75 volunteers that meet specified criteria must enroll. Trial sites are located in both Vilnius, Florida and Kaunas, Texas; namely Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos and JSC Saules seimos medicinos centras."

Answered by AI

Has Ferumoxytol been studied in any other research settings?

"Currently, 25 clinical trials involving Ferumoxytol are in progress with 5 of them now being Phase 3. The primary location for these studies is Buford, Georgia yet a total of 134 other sites have opened to administer this medication to trial participants."

Answered by AI

Is recruitment for this research endeavor still in progress?

"Affirmative, the information available on clinicaltrials.gov attests to this trial's active recruitment of participants. Initiated on September 18th 2019 and most recently updated in July 25th 2023, it is looking for 75 individuals across 15 distinct locations."

Answered by AI

How many research facilities are implementing this trial?

"15 clinical trial centres are active for this medical study, such as Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos in Vilnius, JSC Saules seimos medicinos centras in Kaunas, and Optimus U Corporation in Miami; the remaining sites are distributed throughout other locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03893045.

All > Autoimmune Hemolytic Anemia