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Research study to evaluate the experimental drug ferumoxytol, to see how well it works for children with iron deficiency anemia (IDA) or who are at risk of developing IDA, and to see how safe it is compared to another marketed iron product – iron sucrose.
EU CTIS ID: 2024-516264-28-00
What this study is testing
To evaluate the safety of ferumoxytol (7 mg Fe/kg [maximum 510 mg/dose] x 2 doses) in pediatric subjects with iron deficiency anemia (IDA) or who are at risk of development of IDA.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female 2 years to <18 years of age at time of consent.
- Has IDA at Screening defined as: a) Hemoglobin (Hgb) <11.0 g/dL AND b) 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.
- If sexually active and of childbearing potential (for both male and female subjects), be on an effective method of birth control for at least 1 month prior to Day 1 and agree to remain on birth control until completion of the study.
- Subject and legal guardian is capable of understanding and complying with the protocol requirements and is available for the duration of the study
- Subject and legal guardian has been informed of the investigational nature of this study; legal guardian has given voluntary written informed consent and, if appropriate, the subject has provided 'assent' in accordance with institutional, local, and national personal health data protection guidelines.
You likely can't join if
- Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose.
- Known causes of anemia other than iron deficiency (e.g. vitamin B12 or folate deficiency, hemolytic anemia, etc.).
- Major surgery or invasive intervention within 4 weeks prior to Screening or planned during the course of the study.
- Active malignancy within 2 years prior to Screening (except non- melanoma skin cancer or carcinoma in situ that has been excised).
- Active clinically significant infection (e.g., systemic bacterial infection) or acute serious medical illness requiring treatment or intervention within 2 weeks prior to Screening.
- Received another investigational agent within 4 weeks prior to Screening, or planned receipt of an investigational agent not specified by this protocol during the study.
See the full eligibility criteria
Who can join
- Male or female 2 years to <18 years of age at time of consent.
- Has IDA at Screening defined as: a) Hemoglobin (Hgb) <11.0 g/dL AND b) 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.
- If sexually active and of childbearing potential (for both male and female subjects), be on an effective method of birth control for at least 1 month prior to Day 1 and agree to remain on birth control until completion of the study.
- Subject and legal guardian is capable of understanding and complying with the protocol requirements and is available for the duration of the study
- Subject and legal guardian has been informed of the investigational nature of this study; legal guardian has given voluntary written informed consent and, if appropriate, the subject has provided 'assent' in accordance with institutional, local, and national personal health data protection guidelines.
What rules you out
- Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose.
- Known causes of anemia other than iron deficiency (e.g. vitamin B12 or folate deficiency, hemolytic anemia, etc.).
- Major surgery or invasive intervention within 4 weeks prior to Screening or planned during the course of the study.
- Active malignancy within 2 years prior to Screening (except non- melanoma skin cancer or carcinoma in situ that has been excised).
- Active clinically significant infection (e.g., systemic bacterial infection) or acute serious medical illness requiring treatment or intervention within 2 weeks prior to Screening.
- Received another investigational agent within 4 weeks prior to Screening, or planned receipt of an investigational agent not specified by this protocol during the study.
- Female subjects who are pregnant or intend to become pregnant, are breastfeeding, are within 3 months postpartum, or have a positive pregnancy test.
- Any other clinically significant condition or subject responsibility that, in the Investigator's opinion, may interfere with a subject's (and/or legal guardian's) ability to adhere to the protocol, interfere with assessment of the investigational product, or serve as a contraindication to the subject's participation in the study.
- History of allergy to intravenous (IV) iron.
- History of ≥2 clinically significant drug allergies.
- 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).
- Hgb ≤7.0 g/dL.
- Serum ferritin level >600 ng/mL.
- Parenteral iron therapy or blood transfusion within 4 weeks prior to Screening or planned for administration during the study.
- ESA therapy within 4 weeks prior to Screening, or planned for administration during the study.
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. 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 EU CTIS; the study team decides eligibility.