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

Fast replyRegistered drugNo placebo

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What is this trial about?

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

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.

The research process

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

Step 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
Step 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)
Step 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
Step 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
Step 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 trial?

9 criteria

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 trial?

15 criteria

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

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Verified sites

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Verified
MD Korczowski Bartosz Gabinet Lekarski
Rzeszow, Poland
Responsive
Vilniaus universiteto ligonine Santaros klinikos VšĮ
Vilnius, Lithuania

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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.

What is already known about the treatment

Ferumoxytol - An intravenous iron replacement therapy administered through two separate doses, with each dose providing 7 mg of iron per kilogram of body weight (up to a maximum of 510 mg per dose). This medication belongs to the class of iron oxide nanoparticles and is specifically designed to treat Iron Deficiency Anemia (IDA) by replenishing iron stores in the body. Ferumoxytol works by being taken up by the reticuloendothelial system, where it is broken down and the iron is released into the bloodstream, becoming available for red blood cell production. The medication is currently being studied in pediatric patients who either have IDA or are at risk of developing it, representing an important advancement in treating iron deficiency in children who may not respond well to or tolerate oral iron supplements.

Investigated diseases

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.