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Study on MK-2060 for Preventing Blood Clots in Dialysis Patients with End-Stage Kidney Disease

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What is this trial about?

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

This clinical trial is focused on patients with End Stage Renal Disease (ESRD) who are receiving hemodialysis. The study is investigating a new treatment called MK-2060, which is a solution given through an intravenous infusion. The purpose of the study is to see if MK-2060 can help prevent a condition known as arteriovenous graft thrombosis. This condition occurs when a blood clot forms in a graft used for dialysis, which can cause problems with the dialysis process.

Participants in the study will receive either MK-2060 or a placebo. The study will compare the time it takes for the first occurrence of arteriovenous graft thrombosis between the two groups. The trial will also monitor the number of participants who experience any side effects, including major or clinically relevant bleeding events, and those who stop the study due to side effects. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving MK-2060 or the placebo, to ensure unbiased results.

The study will take place over a period of time, with participants receiving treatment and being monitored for any changes in their condition. The goal is to determine if MK-2060 is effective and safe for patients with ESRD undergoing hemodialysis. This research could potentially lead to better management of arteriovenous graft thrombosis in these patients, improving their overall treatment experience.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is randomly assigned to receive either the medication MK-2060 or a placebo. This process is double-blind, meaning neither the patient nor the healthcare providers know which treatment is being administered.

  2. Step 2

    Medication administration

    The medication, MK-2060, is administered as a solution for infusion. This means it is given through an intravenous infusion, which involves delivering the medication directly into the bloodstream through a vein.

    The frequency and dosage of the infusion are determined by the study protocol and are administered during the patient's regular hemodialysis sessions.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient is monitored for any occurrences of arteriovenous graft thrombosis, which is a blockage in the graft used for dialysis.

    The primary goal is to evaluate the time to the first thrombosis event. Secondary assessments include monitoring for any adverse events, such as bleeding, and the number of participants who discontinue the study due to adverse effects.

  4. Step 4

    Completion of the study

    The study is expected to conclude by October 31, 2024. At the end of the study, the data collected will be analyzed to determine the effectiveness and safety of MK-2060 in preventing arteriovenous graft thrombosis in patients with end-stage renal disease receiving hemodialysis.

Who can join the trial?

5 criteria

  • The patient must have a current diagnosis of **ESRD**. This stands for **End-Stage Renal Disease**, which is the last stage of chronic kidney disease where the kidneys no longer function well enough to meet the body's needs.
  • The patient must be receiving **hemodialysis** at least 3 times per week. Hemodialysis is a treatment that filters and purifies the blood using a machine, which helps when the kidneys are not working properly.
  • Each hemodialysis session must last for a minimum of 3 hours, and the patient must have a mature, normally functioning, and uninfected **AVG**. AVG stands for **Arteriovenous Graft**, which is a type of access used for hemodialysis.
  • At least 75% of the hemodialysis sessions must meet these criteria over the 4 weeks before joining the study.
  • If the patient is a female, she must not be pregnant or breastfeeding. If she is of child-bearing potential, she must agree to use contraception during the study and for at least 90 days after the last dose of the study medication.

Who cannot join the trial?

9 criteria

  • Patients who have a known allergy or bad reaction to the study medication or any of its ingredients.
  • Patients who are currently participating in another clinical trial or have participated in one within the last 30 days.
  • Patients with a history of bleeding disorders, which means they have problems with blood clotting.
  • Patients who have had a recent major surgery or are planning to have surgery during the study period.
  • Patients with severe liver disease, which means their liver is not working properly.
  • Patients with severe kidney disease, which means their kidneys are not working properly.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse within the past year.
  • Patients with any other medical condition that the study doctors think would make it unsafe for them to participate.
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Investigated drugs

MK-2060 is a medication being studied for its ability to prevent blood clots in patients with end-stage kidney disease who are undergoing hemodialysis. The trial aims to see if this medication can increase the time before a blood clot forms in the arteriovenous graft, which is used to connect a vein and an artery for dialysis treatment.

What is already known about the treatment

MK-2060 – This medication is administered to patients through an intravenous route, typically during hemodialysis sessions. It is currently in Phase 2 clinical trials, focusing on its effectiveness and safety for patients with end-stage renal disease. The primary therapeutic indication for MK-2060 is the prevention of arteriovenous graft thrombosis, a common complication in patients undergoing hemodialysis. At the molecular level, MK-2060 works by inhibiting specific pathways that lead to blood clot formation, thereby reducing the risk of thrombosis. It is classified pharmacologically as an anticoagulant, aiming to improve vascular access outcomes in affected patients.

Investigated diseases

Arteriovenous Graft Thrombosis – This condition occurs when a blood clot forms in an arteriovenous graft, which is a connection made between an artery and a vein, often used for dialysis access. The clot can block blood flow through the graft, leading to reduced effectiveness of dialysis treatment. Over time, repeated thrombosis events can damage the graft, requiring surgical intervention or replacement. The progression of this condition can lead to increased complications in managing dialysis and maintaining vascular access. Regular monitoring and preventive measures are essential to manage the risk of thrombosis in patients with arteriovenous grafts.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511055-17-00Protocol codeMK-2060-007Estimated enrolment545 patientsSponsorMerck Sharp & Dohme LLC

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