Actively Recruiting
Phase 3 Study of Ferumoxytol Compared to Iron Sucrose to Treat Iron Deficiency Anemia in Children with Chronic Kidney Disease
Led by AMAG Pharmaceuticals, Inc. · Updated on 2026-04-17
129
Participants Needed
21
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and pharmacokinetics of ferumoxytol compared to iron sucrose in children with chronic kidney disease CKD who have iron deficiency anemia IDA or are at risk of developing it. The study focuses on pediatric patients aged 2 to under 18 years and aims to better understand ferumoxytols profile in this group. This Phase 3, randomized, open-label study involves multiple centers and approximately 125 participants. Participants will be randomly assigned in a 21 ratio to receive either ferumoxytol or iron sucrose. Those in the ferumoxytol group will get two intravenous infusions of 7.0 mg Fekg up to 510 mg per dose, the first on Day 1 and the second 2 to 8 days later. Those receiving iron sucrose will have dosing based on dialysis status hemodialysis-dependent patients receive 2 mg Fekg on consecutive dialysis sessions for 10 doses, and non-hemodialysis-dependent or peritoneal dialysis-dependent patients receive 4 mg Fekg up to three times per week for 5 doses, with total maximum doses capped at 1000 mg. The study lasts up to 7 weeks, including a 2-week screening period and a 5-week treatment period. Researchers will monitor hemoglobin changes, adverse events, and special safety concerns during 49 days of follow-up. Assessments include blood tests to measure hemoglobin and iron levels, safety evaluations, and pharmacokinetic and pharmacodynamic analyses. This helps determine how participants respond and tolerate the treatments over time.
CONDITIONS
Brief Title
A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 2 to under 18 years at time of consent
- Has iron deficiency anemia defined by hemoglobin less than 12.0 g/dL and either transferrin saturation less than 40% or ferritin less than 100 ng/mL, or is at risk of developing iron deficiency anemia
- Has chronic kidney disease defined as being on chronic hemodialysis, receiving chronic peritoneal dialysis, having an estimated glomerular filtration rate below 60 mL/min/1.73 m2, or having structural or functional kidney abnormalities lasting more than 3 months
- For non-hemodialysis patients, has a documented history of unsatisfactory or intolerable oral iron therapy or oral iron is medically inappropriate
- If sexually active and of childbearing potential, agrees to use effective birth control from at least 1 month before dosing until study completion
You will not qualify if you...
- Known allergic reactions to ferumoxytol or iron sucrose
- History of allergy to intravenous iron
- History of multiple drug allergies (more than 2)
- Low systolic blood pressure below age-based thresholds
- Hemoglobin less than or equal to 7.0 g/dL
- Serum ferritin level greater than 600 ng/mL
Research Team
C
Clinical Trial Interest
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