Ongoing Clinical Trials for Iron Deficiency
This article provides information about 5 ongoing clinical trials investigating treatments for iron deficiency. These studies explore various iron replacement therapies in patients with different underlying conditions, including chronic heart failure, colorectal cancer, and severe aortic stenosis. The trials are being conducted across multiple European countries and involve both intravenous and oral iron supplements.
Clinical trial locations
- Bulgaria
- Croatia
- Czechia
- Denmark
- Hungary
- Italy
- Latvia
- Lithuania
- Netherlands
- Poland
- Portugal
- Romania
- Slovakia
- Spain
Study on Ferric Derisomaltose for Patients with Iron Deficiency and Chronic Heart Failure
This study is investigating whether treating iron deficiency can improve outcomes in people with chronic heart failure. The trial is testing ferric derisomaltose, an iron supplement given through an intravenous infusion.
Main inclusion criteria: Participants must be at least 18 years old with chronic heart failure and a left ventricular ejection fraction of 45% or less, meaning their heart isn’t pumping blood as effectively as it should. They need to have low iron levels, shown by a transferrin saturation below 20% and hemoglobin levels between 9-13 g/dL for women or 9-14 g/dL for men. Participants should be on the best tolerated medications for heart failure and must show signs of higher risk, such as recent hospitalization or elevated natriuretic peptides, which indicate heart stress.
Main exclusion criteria: People without chronic heart failure, those who don’t have iron deficiency, or those not experiencing heart failure symptoms cannot participate. The study is also not open to vulnerable populations who may need special care or protection.
Main focus: The study aims to determine whether ferric derisomaltose can reduce deaths related to heart problems and decrease the number of hospital visits due to worsening heart failure. Researchers will monitor participants over time to track health outcomes, symptoms, and iron levels in the blood.
Investigational drug: Ferric derisomaltose is an intravenous iron replacement therapy designed to replenish iron stores in the body. Iron is essential for producing healthy red blood cells and improving oxygen transport throughout the body.
Study on the Effects of Intravenous Ferric Derisomaltose in Non-Anemic Iron Deficient Patients with Colorectal Cancer
This trial is examining the effects of intravenous iron treatment in patients with colorectal cancer who have iron deficiency but are not anemic. The treatment being tested is ferric derisomaltose, also known as Monofer.
Main inclusion criteria: Participants must be at least 18 years old and scheduled for surgery to remove colon or rectal cancer at stage I-III, indicating early to moderately advanced disease. They need to have iron deficiency, defined as ferritin levels of 100 micrograms per liter or less, or transferrin saturation of 20% or less. Their hemoglobin level must be greater than 7.0 mmol/L.
Main exclusion criteria: Individuals without iron deficiency, those not diagnosed with colorectal cancer, people outside the specified age range, and members of vulnerable populations cannot participate.
Main focus: The study aims to evaluate how iron treatment affects physical capacity and immune function in these patients. Researchers will analyze changes in the Neutrophil to Lymphocyte Ratio and use advanced profiling methods to understand immune responses. The study will also investigate effects on the tumor environment and overall health outcomes over both short and long periods.
Investigational drug: Ferric derisomaltose is given through an intravenous infusion directly into the bloodstream. It works by replenishing iron stores, which is essential for various cellular functions including oxygen transport and DNA synthesis.
Study on Vitamin D and Oral Iron for Patients with Chronic Heart Failure and Iron Deficiency
This 24-week study is comparing two different approaches to treating iron deficiency in people with chronic heart failure: a combination of vitamin D with oral iron called sucrosomial iron, versus an intravenous iron treatment known as ferric carboxymaltose.
Main inclusion criteria: Participants must have stable chronic heart failure with symptoms classified as NYHA functional class II-III, meaning some limitation in physical activity. They must be at least 18 years old and not have been hospitalized or in the emergency room for heart failure in the last 3 weeks. Their left ventricle ejection fraction should be 45% or less, and they need elevated natriuretic peptide levels indicating heart failure severity. Iron deficiency must be present, shown by ferritin levels below 100 ng/mL or transferrin saturation below 20% if ferritin is between 100-300 ng/mL. Vitamin D levels must be below 50 nmol/L.
Main exclusion criteria: People without chronic heart failure or iron deficiency cannot participate, nor can those outside the specified age range or members of vulnerable populations.
Main focus: The study will assess whether the oral combination of vitamin D and sucrosomial iron can improve heart failure symptoms as effectively as the intravenous ferric carboxymaltose. The main measure of success is improvement in the Six-Minute Walking Test, which assesses physical capacity. Quality of life and heart function will also be evaluated.
Investigational drugs: Sucrosomial iron is an oral iron supplement taken by mouth, designed to be better absorbed and gentler on the digestive system. Vitamin D is added to help with iron absorption and may have additional benefits for heart muscle function. Ferric carboxymaltose is an intravenous iron given through an IV infusion for rapid absorption.
Study comparing Sucrosomial Iron and Ferric Maltol treatment for women with iron deficiency
This 12-week study focuses specifically on women with iron deficiency and compares two different oral iron supplements: Sucrosomial Iron and Ferric Maltol.
Main inclusion criteria: Participants must be women aged 18 or older with either mild anemia (hemoglobin between 11.0 and 12.0 g/dL) or moderate anemia (hemoglobin between 8.0 and 11.0 g/dL). They must be diagnosed with iron deficiency and willing to sign an informed consent form.
Main exclusion criteria: Pregnant or breastfeeding women cannot participate. Other exclusions include current participation in other trials, known allergies to iron supplements, serious medical conditions affecting iron absorption, recent blood transfusion within 3 months, current use of other iron supplements, inflammatory bowel disease, active gastrointestinal bleeding, severe liver or kidney problems, hemochromatosis (too much iron storage), and recent major surgery within 3 months.
Main focus: The study aims to determine which medication is more effective at helping patients achieve normal blood hemoglobin levels and improve symptoms related to iron deficiency, such as fatigue. Researchers will track how well each medication restores normal iron levels and compare how well patients tolerate them.
Investigational drugs: Sucrosomial iron uses a unique phospholipid membrane technology to protect iron molecules, making it easier for the body to absorb while reducing stomach upset. Ferric maltol combines iron with maltol, which helps the body absorb iron more effectively and is designed to be well-tolerated.
Study on Iron Infusion with Ferric Carboxymaltose for Elderly Patients with Severe Aortic Stenosis and Iron Deficiency Undergoing TAVI
This study is investigating whether iron infusion can improve quality of life and exercise capacity in elderly patients with severe aortic stenosis and iron deficiency who are undergoing a heart valve replacement procedure called TAVI (Transcatheter Aortic Valve Implantation).
Main inclusion criteria: Participants must be 65 years or older with severe aortic stenosis (a narrowed heart valve) and iron deficiency. They must be undergoing a successful TAVI procedure. Iron deficiency is defined as ferritin levels below 100 micrograms per liter or transferrin saturation below 20%. Participants must be able to complete assessments for quality of life, exercise capacity, and cognitive function, including questionnaires and a 6-minute walk test.
Main exclusion criteria: People without severe aortic stenosis and iron deficiency, those not undergoing TAVI, individuals outside the specified age range, and members of vulnerable populations cannot participate.
Main focus: The study will assess whether ferric carboxymaltose iron infusion can improve quality of life and physical abilities in these patients. Participants will be monitored over several months with assessments including questionnaires and walking tests. The trial will evaluate changes in quality of life, exercise capacity, cognitive function, and overall well-being.
Investigational drug: Ferric carboxymaltose (Ferinject) is given intravenously, directly into a vein. It works by releasing iron that is incorporated into hemoglobin and other iron-containing enzymes essential for oxygen transport and energy production throughout the body.
Summary
These five clinical trials represent diverse approaches to treating iron deficiency across different patient populations in Europe. A notable pattern is the concentration of research on chronic heart failure patients, with two trials specifically addressing this condition and one comparing oral versus intravenous iron approaches. Central and Eastern European countries, particularly Lithuania, Portugal, Slovakia, Latvia, Poland, Romania, Bulgaria, Czechia, Croatia, and Hungary, are hosting the largest multi-country trial focused on heart failure.
The trials investigate both intravenous iron therapies (ferric derisomaltose, ferric carboxymaltose) and oral iron supplements (sucrosomial iron, ferric maltol), reflecting interest in comparing different delivery methods. Several studies combine iron with vitamin D or examine iron’s effects on immune function, suggesting researchers are exploring broader therapeutic benefits beyond simply correcting deficiency. The trials also address iron deficiency in specialized contexts, including colorectal cancer patients and elderly individuals undergoing heart valve procedures, demonstrating recognition that iron deficiency impacts various medical conditions differently.
