Iron Deficiency Anemia study: Ferumoxytol vs Iron sucrose
Official title A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
ClinicalTrials.gov ID: NCT03893045
What this study is testing
What is Ferumoxytol?
Ferumoxytol is an investigational intravenous iron product being studied as a potential treatment for iron deficiency anemia in children. Ferumoxytol is designed to provide a source of elemental iron that can be taken up by the body and incorporated into hemoglobin.
Also referred to as Feraheme.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn whether ferumoxytol can safely treat iron deficiency anemia in pediatric patients.
- Who it's for
- Children 2 to <18 years old who have iron deficiency anemia or are at risk, except those with chronic kidney disease.
- What's involved
- Participants will receive ferumoxytol infusions and attend study visits for monitoring and tests.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Male or female 2 years to \<18 years of age at time of consent
- Hemoglobin (Hgb) \<11.0 g/dL AND
- 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...
You likely can't join if
- Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose
- History of allergy to intravenous (IV) iron
- History of ≥2 clinically significant drug allergies
- people 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)
- Hgb ≤7.0 g/dL
See the full eligibility criteria
- Male or female 2 years to \<18 years of age at time of consent
- Hemoglobin (Hgb) \<11.0 g/dL AND
- 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
- Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose
- History of allergy to intravenous (IV) iron
- History of ≥2 clinically significant drug allergies
- people 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)
- Hgb ≤7.0 g/dL
- Serum ferritin level \>600 ng/mL
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States; San Antonio, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.