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Ongoing Clinical Trials for Anaemia

This article provides detailed information about 9 ongoing clinical trials investigating treatments for anaemia, including conditions such as myelodysplastic syndromes, sickle cell disease, beta-thalassemia, myelofibrosis, and anaemia associated with major surgery or peripheral artery disease. The trials are being conducted across multiple European countries and involve investigational drugs including elritercept, ferric carboxymaltose, luspatercept, mitapivat, AG-946, RVU120, and ruxolitinib.

Clinical trial locations

Study of Elritercept for Treating Anemia in Adults with Low to Intermediate Risk Myelodysplastic Syndromes

This trial is investigating elritercept (also known as KER-050) as a potential treatment for adults with myelodysplastic syndromes who require regular blood transfusions due to low red blood cell counts. The medication is given as an injection under the skin and is being compared to a placebo to determine its effectiveness.

Main inclusion criteria: Adults aged 18 or older with a confirmed diagnosis of very low, low, or intermediate-risk myelodysplastic syndromes who depend on regular blood transfusions. Participants must have received between 4 to 7 red blood cell units in the 16 weeks before joining, or 8 or more units during the same period. They should have tried and not responded to, or cannot tolerate, treatments that help the body produce more red blood cells, known as erythropoiesis-stimulating agents. Participants must also have less than 5% immature blood cells in their bone marrow and be able to perform daily activities reasonably well.

Main exclusion criteria: Individuals with other types of cancer, those who have had a recent heart attack within the last 6 months, people with uncontrolled high blood pressure, severe liver or kidney disease, pregnant or breastfeeding women, and those who have received another experimental drug within the last 30 days cannot participate. People with a history of allergic reactions to similar medications or active infections requiring treatment are also excluded.

Trial focus: The main goal is to evaluate whether elritercept can reduce the need for blood transfusions in these patients. Researchers will measure if participants can achieve transfusion independence, meaning they do not need transfusions for at least eight weeks during the study. The trial will also closely monitor participants for any side effects, changes in vital signs, laboratory test results, and heart function.

Investigational drug: Elritercept is being tested to see if it can help the body produce more red blood cells on its own, potentially reducing the need for transfusions and improving quality of life for people with myelodysplastic syndromes.

Study on Intravenous Ferric Carboxymaltose for Preoperative Anemia in Patients with Lower Limb Peripheral Artery Disease

This study is examining how intravenous iron treatment with ferric carboxymaltose (Ferinject) can help patients with poor blood flow to the legs who have developed insufficient red blood cells before undergoing surgery to restore blood flow. The treatment is given directly into the veins to increase iron levels and improve red blood cell production.

Main inclusion criteria: Patients must be 18 years or older with a confirmed diagnosis where hemoglobin levels are below 13.0 g/dL in men or below 12 g/dL in women. They must have chronic reduced blood flow to the legs classified as Rutherford-Baker grades 2-5 or Fontaine grades II-IV. Participants should be planning to have blood flow restoration surgery scheduled between 48 hours and 3 weeks after joining. They must have iron deficiency with ferritin levels below 100 ng/ml or between 100-500 ng/ml with iron saturation below 20%, and be taking oral iron supplements. Written consent is required.

Main exclusion criteria: Patients who do not have the required blood cell deficiency, those without chronic reduced blood flow to the legs, individuals not undergoing blood flow restoration surgery, and those outside the specified age range cannot participate.

Trial focus: The primary aim is to determine if intravenous iron treatment can reduce the need for blood transfusions during and after surgery. Researchers will monitor hemoglobin levels, assess the impact on hospital stay length, and evaluate overall recovery and quality of life following surgery.

Investigational drug: Intravenous ferric carboxymaltose is being used to replenish iron stores in the body, which is essential for producing hemoglobin and red blood cells, thereby addressing the blood cell deficiency in these patients.

Study on Iron and Mannitol for Anemia Recovery in Patients After Major Surgery with Blood Loss

This trial is studying whether giving 1000 mg of ferric carboxymaltose, a form of iron delivered through a vein, immediately after certain major surgeries can improve recovery in patients who experience significant blood loss. The surgeries include liver or pancreatic procedures, or complex aortic surgery.

Main inclusion criteria: Participants must provide written consent, be older than 18 years of age, weigh more than 50 kg, and be scheduled for complex aortic surgery, liver resection, or pancreatic resection. Both male and female participants are eligible.

Main exclusion criteria: Patients with known allergies to the study medication, those who are pregnant or breastfeeding, individuals with severe kidney or liver disease, those who have had a recent heart attack or stroke, people with uncontrolled high blood pressure, patients with certain blood disorders, those currently in another clinical trial, or anyone with medical conditions that would make participation unsafe are excluded.

Trial focus: The study aims to see if iron treatment can reduce the number of blood transfusions needed, prevent severe blood cell deficiency, and improve quality of life five weeks after surgery. Researchers will also monitor the treatment’s effects on recovery, complications after surgery, and the ability to receive further cancer treatments if needed. Participants will be followed for up to five years to observe long-term effects.

Investigational drug: Ferric carboxymaltose works by replenishing iron stores in the body, which is essential for producing hemoglobin, the protein in red blood cells that carries oxygen throughout the body.

Study on Long-Term Safety of Luspatercept for Patients with Myelodysplastic Syndrome, Beta-Thalassemia, or Myelofibrosis Who Previously Participated in Luspatercept Trials

This study is monitoring the long-term safety of luspatercept (also known as ACE-536 or BMS-986346) in participants who previously took part in other luspatercept trials. The conditions being studied include myelodysplastic syndrome, beta-thalassemia, and myelofibrosis, which are blood and bone marrow disorders that can cause blood cell production problems.

Main inclusion criteria: Participants must be at least 18 years old, willing to follow the study visit schedule, and already enrolled in a previous luspatercept study. They must currently be receiving luspatercept and benefiting from it, previously received a placebo and should now start treatment, or be in the follow-up phase of the previous study. Participants must understand and sign a consent form. For women who can have children, two negative pregnancy tests are required before starting treatment, and they must agree to effective birth control. Men must agree to use protection during sexual contact.

Main exclusion criteria: Patients who have not participated in previous luspatercept trials, those with a history of progression to acute myeloid leukemia, individuals who have developed other cancers or pre-cancerous conditions, and those outside the specified age range cannot participate.

Trial focus: The study evaluates the long-term safety of luspatercept, including monitoring for any progression to more serious conditions such as acute myeloid leukemia or development of other cancers. Participants receive luspatercept as an injection under the skin and are regularly assessed by healthcare professionals for up to 360 days.

Investigational drug: Luspatercept is being studied for its ability to help the body produce more red blood cells by binding to certain proteins that regulate blood cell production. It is classified as an erythroid maturation agent.

Study on the Effectiveness and Safety of Mitapivat for Patients with Sickle Cell Disease

This trial is evaluating mitapivat, an oral medication taken as tablets, in individuals with sickle cell disease, a genetic condition that causes red blood cells to become misshapen, leading to various health problems including blood cell deficiency and painful episodes.

Main inclusion criteria: Participants must be at least 16 years old and at a certain stage of physical development. They must have a confirmed diagnosis of sickle cell disease and have experienced between 2 and 10 painful episodes in the past year. Hemoglobin levels must be between 5.5 and 10.5 grams per deciliter. If taking hydroxyurea, the dose must be stable for at least 90 days. Women who can become pregnant must use effective birth control. Written consent is required, with parental permission for minors.

Main exclusion criteria: Individuals without sickle cell disease, those not experiencing related blood cell deficiency or painful episodes, and those outside the specified age range cannot participate.

Trial focus: The study is designed to be double-blind, meaning neither participants nor researchers know who receives the actual medication or placebo. The main goals are to see if mitapivat can improve blood cell deficiency by increasing hemoglobin levels and reduce the frequency of painful episodes. Participants will be monitored regularly throughout the study, which is expected to conclude by April 2030.

Investigational drug: Mitapivat works by activating the enzyme pyruvate kinase, which plays a crucial role in red blood cell energy production, thereby improving their function and survival.

Study of AG-946 for Treating Anemia in Patients with Lower-Risk Myelodysplastic Syndromes

This trial is investigating AG-946, taken as a coated tablet by mouth, for treating blood cell deficiency caused by lower-risk myelodysplastic syndromes, a group of blood disorders affecting the bone marrow. The study is divided into two phases: the first explores if the treatment shows promise, and the second looks at whether it can help patients become independent of blood transfusions.

Main inclusion criteria: Participants must be at least 18 years old with a documented diagnosis meeting criteria for lower-risk disease (risk score of 3.5 or less and less than 5% immature blood cells in bone marrow). For Phase 2a, participants either do not need transfusions or have received less than 3 red blood cell units in the 16 weeks before starting. For Phase 2b, participants must have received 3 to 7 units or 8 or more units during the same period. Hemoglobin levels must be below certain thresholds. Participants must be able to perform daily activities reasonably well and agree to use effective birth control if applicable.

Main exclusion criteria: Patients with other types of blood cell deficiency not related to lower-risk myelodysplastic syndromes, those who received another experimental drug within 30 days, individuals with severe allergic reactions to medications, uncontrolled high blood pressure, active infections, significant heart disease, liver or kidney disease, pregnant or breastfeeding women, those with a history of cancer (except certain skin cancers), and anyone who had major surgery within 4 weeks cannot participate.

Trial focus: The study aims to determine if AG-946 can help patients become less dependent on blood transfusions by improving red blood cell production. Participants will take the medication for up to 180 days and be monitored for changes in hemoglobin levels and any side effects.

Investigational drug: AG-946 is being tested for its potential to target specific pathways in the body to improve red blood cell production in patients with lower-risk myelodysplastic syndromes.

Study of Elritercept for Treating Anemia in Patients with Low to Intermediate Risk Myelodysplastic Syndromes (MDS)

This study is testing elritercept (KER-050), a solution for injection given under the skin, in patients with very low, low, or intermediate risk myelodysplastic syndromes who have blood cell deficiency. The trial evaluates the safety and tolerability of different doses of the medication.

Main inclusion criteria: Participants must have a confirmed diagnosis according to WHO classification with a risk level of very low, low, or intermediate. There should be less than 5% immature blood cells in the bone marrow, and white blood cell count should be below 13,000 per microliter. Participants must have blood cell deficiency shown by specific transfusion patterns or hemoglobin levels. They should be able to perform daily activities reasonably well and agree to use effective birth control if applicable.

Main exclusion criteria: The specific exclusion criteria were not detailed in the source data, but typically would include conditions that make participation unsafe or could interfere with study results.

Trial focus: The study is divided into two main parts: the first involves receiving increasing doses to determine the most suitable dose, and the second confirms the safety of the selected dose. There is also a long-term extension phase to assess ongoing safety. Researchers will monitor participants for side effects and evaluate if elritercept can reduce the need for blood transfusions and improve blood cell production.

Investigational drug: Elritercept (KER-050) works by stimulating red blood cell production and is classified as a hematopoietic agent involved in blood cell formation.

Study of SEL120 Monohydrochloride for Treating Anemia in Patients with Lower-Risk Myelodysplastic Syndromes (MDS)

This trial is studying RVU120, an oral medication taken as capsules, for treating blood cell deficiency in patients with lower-risk myelodysplastic neoplasms. The medication is a small-molecule anticancer drug that works as a CDK8 kinase inhibitor.

Main inclusion criteria: Participants must be at least 18 years old with a diagnosis of myelodysplastic neoplasms classified as very low, low, or intermediate risk. They must have symptomatic blood cell deficiency documented in the 16 weeks before starting treatment. There should be no available approved therapy options, as decided by the doctor. Participants must have stopped any anti-cancer treatment for at least 2 weeks, have adequate heart function, and meet specific laboratory test criteria. Men must use effective contraception and not donate blood or sperm during the study and for 28 weeks after. All COVID-19 vaccinations must be current according to national guidelines.

Main exclusion criteria: Patients with a different type of blood cell deficiency not related to the specified risk levels, those outside the required age range, individuals not part of the specific trial group, or those unable to give informed consent may not be eligible.

Trial focus: The study evaluates how well RVU120 can improve red blood cell production in these patients. Participants will receive the medication over multiple cycles, with regular monitoring of hemoglobin levels and assessment of the need for blood transfusions. The treatment consists of 150 mg per cycle, and response will be evaluated after 8 full cycles.

Investigational drug: RVU120 works by targeting specific pathways involved in blood cell production, aiming to enhance red blood cell production and improve symptoms in patients with lower-risk myelodysplastic neoplasms.

Study on KER-050 and Ruxolitinib for Patients with Myelofibrosis and Anemia

This study is exploring KER-050, tested both alone and in combination with ruxolitinib (also known by its code name INCB018424), in people with myelofibrosis, a type of bone marrow disorder that affects blood cell production. The trial is evaluating the safety and effectiveness of these treatments in patients who also have insufficient red blood cells.

Main inclusion criteria: Participants must be at least 18 years old with an ECOG performance score of 2 or less and a life expectancy of at least 12 months. They must have a confirmed diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis. Participants must have blood cell deficiency shown by needing certain blood transfusions or having low hemoglobin levels. For some study groups, participants must have been previously treated with a JAK inhibitor. For others, they must have been taking ruxolitinib for at least 8 weeks on a stable dose. Effective birth control is required for those who can have children.

Main exclusion criteria: Patients without myelofibrosis or blood cell deficiency, those not adults, individuals unable to safely take the medication due to other health conditions, pregnant or breastfeeding women, those participating in another trial, people with recent major surgery or surgery planned during the study, those with certain medical conditions interfering with the study, individuals with allergies to the study medication, and those not agreeing to follow study procedures are excluded.

Trial focus: The study is divided into parts: initially, participants receive increasing doses of KER-050 to determine the safest and most effective dose. The study then expands to include more participants to further assess safety. There is also a long-term extension to evaluate ongoing safety with or without ruxolitinib. The trial aims to see if these treatments can help manage symptoms, improve blood cell counts, reduce transfusion needs, and affect spleen size.

Investigational drugs: KER-050 is given as an injection and targets specific pathways involved in blood cell production. Ruxolitinib is already used to treat myelofibrosis and is being combined with KER-050 to see if the combination improves treatment outcomes.

Summary

These nine clinical trials represent a diverse range of approaches to treating various forms of blood cell deficiency across Europe. A notable concentration of trials focuses on myelodysplastic syndromes, with multiple studies investigating elritercept (KER-050) and other novel agents like AG-946 and RVU120. France, Germany, Italy, and Spain emerge as major centers for this research, hosting the majority of these trials.

Several trials are exploring iron supplementation strategies, both for surgical patients and those with peripheral artery disease. The studies on luspatercept and mitapivat expand the scope to include sickle cell disease, beta-thalassemia, and myelofibrosis, indicating a comprehensive effort to address multiple blood disorders that result in insufficient red blood cells.

Most trials emphasize reducing dependence on blood transfusions as a primary outcome, which could significantly improve quality of life for patients if successful. The research spans different phases of clinical development, from early dose-finding studies to larger confirmatory trials, with some including long-term extension phases to monitor safety over extended periods.

Ongoing Clinical Trials on Anaemia

  • Study of luspatercept for patients with rare inherited anemias to reduce transfusion needs and improve hemoglobin levels

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy

  • Study of SEL120 Monohydrochloride for Treating Anemia in Patients with Lower-Risk Myelodysplastic Syndromes (MDS)

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Poland Spain

  • Study on Canakinumab for Treating Anemia in Patients with Lower-Risk Myelodysplastic Syndromes or MDS/MPN

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

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