Study comparing ferumoxytol and iron sucrose for treating iron deficiency anemia in children

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What is this study about?

This clinical trial focuses on children with Iron Deficiency Anemia (IDA), a condition where the body doesn’t have enough iron to produce healthy red blood cells. The study will test two medications: ferumoxytol and iron sucrose, which are both given through intravenous administration (directly into a vein).

The main purpose of this research is to evaluate how safe and effective ferumoxytol is for treating children with iron deficiency anemia or who might develop this condition. During the study, participants will receive either ferumoxytol (two doses of 7 mg of iron per kilogram of body weight, up to 510 mg per dose) or iron sucrose (up to 200 mg daily).

The treatment period lasts 5 days, during which doctors will monitor the children’s response to the medication. They will check various health indicators, including the amount of iron in the blood and how well the body is using it. The study will also look at how the medicine moves through the body and how well it is tolerated by the young patients.

1 Initial assessment

Your blood will be tested to check hemoglobin levels and other iron-related parameters

A medical examination will be performed to confirm your eligibility for the study

2 Treatment assignment

You will be randomly assigned to receive either ferumoxytol or iron sucrose through an intravenous line

If assigned to ferumoxytol: you will receive 7 mg of iron per kg of body weight (up to 510 mg per dose) in two separate doses

The medication will be administered through a vein (intravenous use)

3 Monitoring period – Week 1

Your vital signs will be monitored, including blood pressure, heart rate, and breathing rate

Blood samples will be collected to measure how the medication is processed by your body

Any side effects will be recorded

4 Follow-up visits – Week 5

Blood tests will be performed to measure your hemoglobin and iron levels

Your overall health status will be evaluated

Changes in your iron levels will be assessed

5 Final assessment

Final blood tests will be conducted

Overall evaluation of your response to the treatment

Documentation of any side effects throughout the study period

Who Can Join the Study?

  • Age between 2 and 17 years old at the time of joining the study
  • Must have iron deficiency anemia shown by:
    • Hemoglobin (a protein that carries oxygen in blood) less than 11.0 g/dL
    • And at least one of these:
      • Transferrin saturation (a measure of iron in the blood) less than 20%
      • Ferritin (a protein that stores iron) less than 100 ng/mL
  • Previous unsuccessful treatment with oral iron supplements, or cannot take oral iron, or oral iron is not suitable for medical reasons
  • If sexually active and able to have children, must use effective birth control for at least 1 month before starting the study and continue throughout the study
  • Patient and legal guardian must be able to understand and follow study requirements
  • Patient and legal guardian must be available for the entire study duration
  • Legal guardian must provide written consent, and where appropriate, the patient must provide their agreement to participate

Who Cannot Join the Study?

  • History of allergic reactions to iron products or other medications
  • Current severe infection or inflammation
  • Recent major surgery (within 30 days)
  • Uncontrolled high blood pressure (also called hypertension)
  • Active bleeding or significant blood loss
  • Liver disease or abnormal liver function
  • Kidney disease or abnormal kidney function
  • Current cancer treatment
  • Pregnancy or breastfeeding
  • Participation in another clinical trial within the past 30 days
  • Having received intravenous iron treatment within the past 8 weeks
  • History of severe heart problems (such as heart failure or unstable heart disease)
  • Conditions that affect iron absorption or storage in the body
  • Severe mental health conditions that could affect participation
  • Unable to follow study procedures or attend scheduled visits

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
Saules seimos medicinos centras UAB Kaunas Lithuania
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
MD Korczowski Bartosz Gabinet Lekarski Rzeszow Poland

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

Trial status

Country Status Recruitment Start
Lithuania Lithuania
Recruiting
16.05.2019
Poland Poland
Recruiting
16.05.2019

Trial locations

Investigated drugs:

Ferumoxytol is an intravenous iron replacement medication used to treat iron deficiency anemia. It works by helping the body restore iron levels when oral iron supplements aren’t effective enough or can’t be tolerated. The medication is given through an IV and helps the body produce more red blood cells to carry oxygen throughout the body. This form of iron is specially designed to release iron in a controlled way and is bound to a carbohydrate complex that helps prevent side effects that can occur with other forms of intravenous iron.

Iron Deficiency Anemia (IDA) – A condition that develops when the body doesn’t have enough iron to produce adequate amounts of hemoglobin, a protein in red blood cells that carries oxygen to tissues. The body gradually becomes iron deficient, first depleting its iron stores, then showing reduced iron transport, and finally developing anemia. This condition typically develops slowly as iron levels decline in the body. Common signs include fatigue, weakness, pale skin, and shortness of breath during physical activity. The condition can affect people of any age, but it’s particularly common in growing children, pregnant women, and people with certain dietary restrictions.

Trial ID:
2024-516264-28-00
Protocol code:
AMAG-FER-IDA-352
NCT ID:
NCT03893045
Trial Phase:
Therapeutic confirmatory (Phase III)

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