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Comparing ferumoxytol and iron sucrose for treating iron deficiency anemia in children with chronic kidney disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on children with Chronic Kidney Disease (CKD) who have Iron Deficiency Anemia (IDA) or are at risk of developing it. IDA occurs when the body doesn't have enough iron to produce adequate amounts of hemoglobin, a protein in red blood cells that carries oxygen throughout the body. The study aims to evaluate how well a medication called ferumoxytol works compared to another iron medication called iron sucrose.

The study will examine the safety and effectiveness of ferumoxytol, which is given as an intravenous solution (delivered directly into a vein). Participants will receive either ferumoxytol or iron sucrose over a period of 5 days. The treatment involves two doses of ferumoxytol or multiple doses of iron sucrose. The study will monitor how these medications affect the iron levels and blood counts in the participants' bodies.

During the study, doctors will track changes in participants' blood iron levels and hemoglobin (a protein that carries oxygen in the blood). They will also monitor for any side effects that may occur during or after the treatment. The study will pay special attention to how participants' bodies respond to both medications, particularly regarding blood pressure and any allergic reactions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medical assessment

    Your blood tests will be checked to confirm iron deficiency anemia or risk of developing it

    Your kidney function will be evaluated to confirm chronic kidney disease

    A review of your medical history and current medications will be performed

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either ferumoxytol or iron sucrose

    Both medications will be given through an intravenous line (directly into your vein)

  3. Step 3

    First treatment phase

    If assigned to ferumoxytol: you will receive 7.0 mg of iron per kg of body weight (maximum 510 mg per dose)

    The treatment will be given twice during the study

    Your vital signs (blood pressure, heart rate, breathing rate, and temperature) will be monitored during treatment

  4. Step 4

    Monitoring period

    Regular blood tests will be performed to check your hemoglobin levels (a measure of anemia)

    Iron levels in your blood will be monitored

    Any side effects will be recorded

    The monitoring period will last for 5 weeks

  5. Step 5

    Final assessment

    Your blood test results will be evaluated to measure the effectiveness of the treatment

    A final medical examination will be performed

    Any changes in your condition will be documented

Who can join the trial?

11 criteria

  • Age between 2 and 17 years old at the time of consent
  • Must have iron deficiency anemia shown by:
    • Hemoglobin (protein that carries oxygen in blood) less than 12.0 g/dL, and
    • Either TSAT (iron saturation test) less than 40% or ferritin (iron storage protein) less than 100 ng/mL
    • Must have chronic kidney disease shown by one of these:
      • Regular hemodialysis treatment
      • Regular peritoneal dialysis treatment
      • Reduced kidney function (filtration rate below 60 mL/min/1.73 m²)
      • Kidney abnormalities lasting more than 3 months
      • For patients not on hemodialysis: must have tried oral iron supplements without success, or cannot take oral iron, or oral iron is not appropriate for their condition
      • Sexually active participants must use effective birth control methods for at least 1 month before starting the study and continue throughout the study
      • Patient and/or legal guardian must be able to understand and follow study requirements
      • Patient and/or legal guardian must provide written informed consent to participate in the study

Who cannot join the trial?

15 criteria

  • Active or chronic bleeding disorders (conditions that cause abnormal bleeding)
  • Known allergic reactions to any type of iron treatments
  • Recent iron therapy within 4 weeks before the study
  • Severe liver disease (serious problems with liver function)
  • Active infections requiring antibiotics
  • Uncontrolled high blood pressure
  • Blood disorders not related to iron deficiency
  • Current participation in other clinical trials
  • Recent blood transfusion within 12 weeks before the study
  • Any condition that could interfere with the safety of the participant
  • Inability to follow study procedures
  • History of severe allergic reactions to medications
  • Significant heart problems or cardiovascular disease
  • Pregnancy or breastfeeding
  • Active autoimmune diseases (conditions where the immune system attacks the body)
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Investigated drugs

  • Ferumoxytol

    is an intravenous iron replacement medication used to treat iron deficiency anemia. It helps increase iron levels in the body when oral iron supplements aren't working well enough or can't be taken. This medication is particularly useful for people with chronic kidney disease who often develop anemia.

  • Iron Sucrose

    is an established intravenous iron treatment used to replenish iron levels in people with iron deficiency anemia. It's commonly used in patients with chronic kidney disease who need iron supplementation. This medication serves as the comparison treatment (active control) in this study.

What is already known about the treatment

  • Ferumoxytol

    An injectable iron replacement medication administered intravenously for the treatment of iron deficiency anemia, particularly in patients with chronic kidney disease. This superparamagnetic iron oxide nanoparticle formulation allows for controlled release of iron into the bloodstream, where it is taken up by the reticuloendothelial system and gradually incorporated into hemoglobin. As a newer alternative to traditional iron sucrose, ferumoxytol offers the advantage of requiring fewer doses due to its higher iron content per administration, making it particularly suitable for pediatric patients with chronic kidney disease who require iron supplementation.

  • Iron Sucrose

    A well-established intravenous iron replacement medication used as a standard treatment for iron deficiency anemia in patients with chronic kidney disease. It consists of iron hydroxide complexed with sucrose, which releases iron in a controlled manner for incorporation into red blood cells. This medication has been extensively studied and has a proven safety profile, making it a reliable comparator in clinical trials evaluating newer iron replacement therapies, particularly in pediatric populations requiring iron supplementation.

Investigated diseases

  • Iron Deficiency Anemia (IDA)

    A condition where the body doesn't have enough iron to produce adequate amounts of hemoglobin, a protein in red blood cells that carries oxygen throughout the body. The condition develops gradually as body iron stores are depleted and hemoglobin levels fall below normal. Common signs include fatigue, weakness, pale skin, and shortness of breath during physical activity.

  • Chronic Kidney Disease (CKD)

    A gradual loss of kidney function that occurs over time. The kidneys become less efficient at filtering waste products from the blood and maintaining proper fluid balance in the body. The disease progresses through several stages, from mild damage to complete kidney failure. CKD often affects the body's ability to produce enough red blood cells, leading to anemia.

Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-516263-92-00Protocol codeAMAG-FER-CKD-354Estimated enrolment129 patientsSponsorAmag Pharmaceuticals Inc.

sourced from the EU Clinical Trials Register and site verification

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