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1 clinical trial in this condition
BulgariaIn short
There is currently 1 ongoing clinical trial investigating new treatments for arteriovenous graft thrombosis, a condition where blood clots form in grafts used for dialysis. This trial is being conducted across multiple European countries and is testing a new medication called MK-2060 to help prevent these blood clots in patients undergoing hemodialysis for end-stage kidney disease.
This clinical trial is investigating a new treatment for patients who develop blood clots in their dialysis grafts. The condition occurs when a clot forms in an arteriovenous graft, which is a connection between an artery and a vein used to access the bloodstream during dialysis. When these clots form, they can block blood flow and interfere with dialysis treatment, sometimes requiring surgery to fix or replace the graft.
Main focus and goal: The study aims to determine whether MK-2060, a new anticoagulant medication, can help prevent blood clots from forming in arteriovenous grafts. Researchers will measure how long it takes for the first clot to occur in patients receiving MK-2060 compared to those receiving a placebo. The study will also monitor any side effects, particularly bleeding events, and track how many participants need to stop treatment due to adverse effects. This is a double-blind study, meaning neither the patients nor the doctors will know who is receiving the actual medication or the placebo during the trial.
Investigational drug: MK-2060 is an anticoagulant medication given through an intravenous infusion, typically during regular hemodialysis sessions. It works by blocking specific pathways that lead to blood clot formation, thereby reducing the risk of clots forming in the graft.
Who can participate: This study is looking for patients who have been diagnosed with End-Stage Renal Disease (ESRD), which is the final stage of chronic kidney disease when the kidneys can no longer function well enough on their own. Eligible patients must be receiving hemodialysis at least 3 times per week, with each session lasting at least 3 hours. They must have a mature, properly functioning, and uninfected arteriovenous graft. At least 75% of their dialysis sessions over the past 4 weeks must meet these requirements. Female participants of childbearing age must not be pregnant or breastfeeding and must agree to use contraception during the study and for at least 90 days after the last dose of medication.
Who cannot participate: Patients are not eligible if they have a known allergy to the study medication or its ingredients, or if they are currently participating in another clinical trial or have done so within the last 30 days. Those with a history of bleeding disorders or problems with blood clotting cannot join. Patients who have had recent major surgery or are planning surgery during the study period are also excluded. The study is not suitable for those with severe liver disease or severe kidney disease beyond their ESRD diagnosis. Pregnant or breastfeeding women cannot participate, nor can those with a history of drug or alcohol abuse within the past year. Any other medical condition that doctors believe would make participation unsafe will also exclude patients from the study.
Currently, there is one active clinical trial addressing arteriovenous graft thrombosis, focusing specifically on patients with end-stage kidney disease who require regular hemodialysis. The trial is being conducted across eight European countries, including Portugal, Germany, Romania, Czechia, Bulgaria, Sweden, Greece, and Italy, demonstrating a strong European collaborative effort in this area of research.
The study is investigating MK-2060, an anticoagulant medication designed to prevent blood clot formation in dialysis grafts. This represents an important area of research as clot formation in arteriovenous grafts is a common complication for dialysis patients and can significantly impact their treatment quality and require additional interventions. The trial's double-blind design and focus on both effectiveness and safety, particularly monitoring for bleeding events, reflects a comprehensive approach to evaluating this new treatment option.
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