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Research study to evaluate the experimental drug ferumoxytol, to see how well it works for children with chronic kidney disease (CKD) and 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: 2024-516263-92-00
What this study is testing
To evaluate the safety (compared to iron sucrose) and efficacy of ferumoxytol (7.0 mg Fe/kg x 2 [max 510 mg/dose]) in pediatric CKD 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 defined as: a) hemoglobin <12.0 g/dL and b) with either TSAT <40% or ferritin <100 ng/mL; or considered to be at risk of development of IDA, i.e., TSAT<20% with falling hemoglobin during the preceding 2 months and a history of hemoglobin <12 g/dL.
- Has Chronic Kidney Disease defined as one of the following: a. on chronic hemodialysis; b. receiving chronic peritoneal dialysis; c. eGFR of <60 mL/min/1.73 m2; d. has evidence of structural and/or functional abnormalities e.g., persistent albuminuria, abnormal urine sediment, electrolyte and other abnormalities due to tubular disorders for > 3 months.
- For patients other than hemodialysis dependent CKD patients, documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate.
- All subjects (female and male) of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to Day 1 Dosing and agree to remain on birth control until completion of the study.
- Subject and/or legal guardian is capable of understanding and complying with the protocol requirements and is available for the duration of the study.
You likely can't join if
- Known hypersensitivity reaction to any component of ferumoxytol and iron sucrose.
- Major surgery or invasive intervention within 4 weeks prior to Screening, or any planned major surgery or intervention 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 period.
- Female subjects who are pregnant or intend to become pregnant, or are breastfeeding, are within 3 months postpartum, or have a positive pregnancy test.
See the full eligibility criteria
Who can join
- Male or female 2 years to <18 years of age at time of consent.
- Has IDA defined as: a) hemoglobin <12.0 g/dL and b) with either TSAT <40% or ferritin <100 ng/mL; or considered to be at risk of development of IDA, i.e., TSAT<20% with falling hemoglobin during the preceding 2 months and a history of hemoglobin <12 g/dL.
- Has Chronic Kidney Disease defined as one of the following: a. on chronic hemodialysis; b. receiving chronic peritoneal dialysis; c. eGFR of <60 mL/min/1.73 m2; d. has evidence of structural and/or functional abnormalities e.g., persistent albuminuria, abnormal urine sediment, electrolyte and other abnormalities due to tubular disorders for > 3 months.
- For patients other than hemodialysis dependent CKD patients, documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate.
- All subjects (female and male) of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to Day 1 Dosing and agree to remain on birth control until completion of the study.
- Subject and/or legal guardian is capable of understanding and complying with the protocol requirements and is available for the duration of the study.
- Subject and/or legal guardian has been informed of the investigational nature of this study and has given voluntary written informed consent and, if appropriate, the child/adolescent has provided 'assent' and Health Insurance Portability and Accountability Act (HIPAA) or patient protection authorization had been adhered to in accordance with institutional, local, and national personal health data protection guidelines.
What rules you out
- Known hypersensitivity reaction to any component of ferumoxytol and iron sucrose.
- Major surgery or invasive intervention within 4 weeks prior to Screening, or any planned major surgery or intervention 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 period.
- Female subjects who are pregnant or intend to become pregnant, or are breastfeeding, are within 3 months postpartum, or have a positive pregnancy test.
- Any other clinically significant medical or psychiatric disease or 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 multiple drug allergies (>2).
- Low systolic blood pressure (Age 1-9 years <70 + [age in years x 2] mmHg, Age 10-17 years <90 mmHg).
- Hemoglobin ≤7.0 g/dL.
- Serum ferritin level >600 ng/mL.
- Parenteral iron therapy within 4 weeks prior to Day 1 Dosing; or blood transfusion within 4 weeks prior to Day 1 Dosing or planned at the time of Screening.
- Erythropoiesis-stimulating agent (ESA) therapy initiated, stopped or dose changed by >25% within 4 weeks prior to Screening, or anticipated ESA dose change of >20% during the study.
- Known causes of anemia other than iron deficiency (e.g., vitamin B12 or folate deficiency, hemolytic anemia, etc.).
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- 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 Mexico; 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.