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New treatment option for Iron Deficiency Anemia
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 medicine, given as an infusion into a vein, being studied as a potential treatment for iron deficiency anemia.
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
- This is a Phase 3, randomized, open-label, multicenter, study in male and female pediatric subjects (2 years to \<18 years of age) with IDA, or felt by their clinician to be at risk of developing IDA. This study allows for enrollment of subjects with IDA regardless of etiology, except for CKD subjects (pediatric CKD subjects are being studied in a separate ferumoxytol protocol).
- 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
- Has IDA defined as:
- Hemoglobin (Hgb) \<11.0 g/dL AND
- Any one or more of the following:
- Transferrin saturation (TSAT) \<20%
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
- 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
- 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's taking place
- Little Rock, Arkansas, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
- Buford, Georgia, United States
- San Antonio, Texas, United States
- Kaunas, Lithuania
- Klaipėda, Lithuania
- Vilnius, Lithuania
- Bydgoszcz, Poland
- Dębica, Poland
- Katowice, Poland
- Rzeszów, Poland
- Warsaw, Poland
- Wroclaw, Poland
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 - 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?
Study sites include Little Rock, Arkansas, United States; Gainesville, Florida, United States; Miami, Florida, United States; Buford, Georgia, United States; San Antonio, Texas, United States; Kaunas, Lithuania and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.