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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Uniwersytecki Szpital Dzieciecy W Krakowie Cracow Poland
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku samodzielny publiczny zakład opieki zdrowotnej Bialystok Poland
University Of Szeged Szeged Hungary

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Hungary Hungary
Not recruiting
13.08.2018
Lithuania Lithuania
Recruiting
13.08.2018
Poland Poland
Not recruiting
13.08.2018

Trial locations

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.

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 ID:
2024-516263-92-00
Protocol code:
AMAG-FER-CKD-354
NCT ID:
NCT03619850
Trial Phase:
Therapeutic confirmatory (Phase III)

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