Ongoing Clinical Trials for Iron Deficiency Anaemia
There are currently 3 ongoing clinical trials investigating new treatments for iron deficiency anaemia. These studies are testing intravenous iron medications in different patient groups, including children with chronic kidney disease, children with general iron deficiency, and older adults recovering from heart surgery. The trials are being conducted across several European countries including Poland, Lithuania, Hungary, and the Netherlands.
Clinical trial locations
- Hungary
- Lithuania
- Netherlands
- Poland
Comparing ferumoxytol and iron sucrose for treating iron deficiency anemia in children with chronic kidney disease
This study is designed for children aged 2 to 17 years who have chronic kidney disease and also have iron deficiency anaemia or are at risk of developing it. The main goal is to compare two intravenous iron medications: ferumoxytol and iron sucrose.
Who can participate: Children must have low haemoglobin levels (below 12.0 g/dL) along with either low iron saturation (less than 40%) or low ferritin levels (less than 100 ng/mL). They must also have chronic kidney disease, either requiring regular dialysis or showing reduced kidney function. For those not on haemodialysis, they should have tried oral iron supplements without success, be unable to take oral iron, or have medical reasons why oral iron is not suitable. Participants must provide written consent through their legal guardian and be willing to follow study requirements.
Who cannot participate: Children with active or chronic bleeding disorders, known allergic reactions to iron treatments, recent iron therapy within 4 weeks, severe liver disease, active infections requiring antibiotics, uncontrolled high blood pressure, blood disorders unrelated to iron deficiency, recent blood transfusions within 12 weeks, pregnancy or breastfeeding, or active autoimmune diseases are excluded from the study.
Study focus: The trial evaluates the safety and effectiveness of ferumoxytol compared to iron sucrose. Participants receive either two doses of ferumoxytol (7 mg of iron per kg of body weight, up to 510 mg per dose) or multiple doses of iron sucrose over a 5-day treatment period. The study monitors changes in iron levels, haemoglobin counts, blood pressure, and any allergic reactions throughout the 5-week monitoring period.
Investigational drugs: Ferumoxytol is an intravenous iron replacement medication that helps increase iron levels when oral supplements aren’t working effectively. It’s particularly useful for people with chronic kidney disease. Iron sucrose serves as the comparison treatment and is an established intravenous iron therapy commonly used in patients with chronic kidney disease.
Study comparing ferumoxytol and iron sucrose for treating iron deficiency anemia in children
This clinical trial focuses on children with iron deficiency anaemia, testing two intravenous iron medications: ferumoxytol and iron sucrose. The study aims to evaluate the safety and effectiveness of ferumoxytol in treating children who have the condition or might develop it.
Who can participate: Children between 2 and 17 years old with haemoglobin levels below 11.0 g/dL and either transferrin saturation less than 20% or ferritin less than 100 ng/mL can join. They must have previously tried oral iron supplements unsuccessfully, be unable to take oral iron, or have medical reasons why oral iron is unsuitable. Sexually active participants must use effective birth control for at least 1 month before and throughout the study. Legal guardians must provide written consent and both patient and guardian must be available for the entire study duration.
Who cannot participate: Children with a history of allergic reactions to iron products, current severe infection or inflammation, recent major surgery within 30 days, uncontrolled high blood pressure, active bleeding, liver or kidney disease, current cancer treatment, pregnancy or breastfeeding, participation in another trial within 30 days, recent intravenous iron treatment within 8 weeks, severe heart problems, conditions affecting iron absorption or storage, or severe mental health conditions are excluded.
Study focus: The trial compares ferumoxytol (two doses of 7 mg iron per kg body weight, up to 510 mg per dose) with iron sucrose (up to 200 mg daily) over a 5-day treatment period. Researchers monitor iron levels in the blood, how the body uses the medication, and how well children tolerate the treatment. Blood tests are performed regularly to check haemoglobin and iron levels, with a final assessment conducted to measure treatment effectiveness.
Investigational drug: Ferumoxytol is an intravenous iron replacement medication that works by helping the body restore iron levels when oral supplements aren’t effective or can’t be tolerated. It’s specially designed to release iron in a controlled way and is bound to a carbohydrate complex that helps prevent side effects.
Study on Treating Postoperative Anemia in Older Cardiac Surgery Patients with Ferric Derisomaltose and Sodium Chloride
This study focuses on treating iron deficiency anaemia in older patients who have undergone heart surgery. It tests an intravenous iron solution called Monofer, which contains ferric derisomaltose, to see how effective it is in reducing disability 90 days after surgery.
Who can participate: Patients must be mentally competent and aged 70 years or older. They should have undergone elective aortic valve replacement or coronary artery bypass grafting surgery, possibly combined with rhythm surgery. Participants must be expected to have an uncomplicated recovery, with no need for special heart-supporting medications or breathing machines, and should be ready to move to a regular hospital ward by the first day after surgery. They must have moderate iron deficiency anaemia after surgery, with haemoglobin levels between 85 and 110 g/L, ferritin levels below 100 micrograms per litre, or iron saturation below 20%. Both men and women can participate, and they should not belong to a vulnerable population.
Who cannot participate: Patients without iron deficiency anaemia, those who haven’t undergone cardiac surgery, anyone under 18 years old, those unable to give informed consent, pregnant or breastfeeding women, and patients with any other medical condition that doctors think might make participation unsafe are excluded.
Study focus: The trial determines how effective intravenous iron treatment is in reducing disability 90 days after heart surgery. Participants receive either Monofer (ferric derisomaltose) or a sodium chloride solution. The study monitors various health indicators including the need for blood transfusions, changes in blood iron levels, hospital complications, and patient-reported outcomes regarding breathlessness symptoms.
Investigational drug: Intravenous iron is given directly into the bloodstream to quickly increase iron levels and help the body produce more red blood cells. In this trial, it’s used to treat anaemia that occurs after surgery, with the goal of reducing disability and improving recovery in older patients.
Summary
The three ongoing clinical trials for iron deficiency anaemia cover diverse patient populations and settings. Two of the studies focus specifically on paediatric patients, testing ferumoxytol as a potential alternative to iron sucrose in children with or without chronic kidney disease. These trials are concentrated in Eastern European countries, particularly Poland and Lithuania, with one extending to Hungary. The third trial takes a different approach, examining intravenous iron treatment in older adults recovering from cardiac surgery in the Netherlands.
A notable pattern is the focus on intravenous iron formulations across all studies, reflecting situations where oral iron supplements are insufficient or unsuitable. The paediatric trials both investigate ferumoxytol, suggesting growing interest in this medication for children, while the cardiac surgery study uses ferric derisomaltose. All three trials share the common goal of improving patient outcomes by effectively addressing iron deficiency, whether in children with kidney disease, children with general iron deficiency, or older adults recovering from major surgery.
