Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomized Parallel-group, Placebo-controlled, Double-blind, Eventdriven, Multi-center Phase 2 Clinical Outcome Trial of Prevention of Arteriovenous Graft Thrombosis and Safety of MK-2060 in Patients With End Stage Renal Disease Receiving Hemodialysis

This research study is looking at a new medicine called MK-2060. It's designed for people with serious kidney disease who need a type of treatment called haemodialysis. For haemodialysis, a special tube, called an arteriovenous graft (AVG), is put into the arm. Sometimes, blood clots can form in these grafts, which can be a problem. This study aims to find out if MK-2060 can help prevent these clots from forming. We will compare it to a dummy medicine (placebo) to see if it works and if it's safe. Participants will be followed to see how long it takes for a first clot to form, and we'll also keep a close eye on any side effects or bleeding.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

09 Jul 2024

Prevention of arteriovenous graft thrombosis

What is this study about?

This study is for people who have serious kidney disease and need regular treatment called haemodialysis. For haemodialysis to work well, doctors create a special connection, often using a tube called an arteriovenous graft (AVG), usually in your arm. This graft helps to get your blood to and from the kidney machine.

However, a common problem with these grafts is that blood clots can sometimes form inside them. These clots can stop the graft from working properly, meaning you might need extra doctor visits or procedures to fix it. This study is testing a new medicine, MK-2060, to see if it can help prevent these blood clots from happening in the first place.

The main goal of the study is to see if MK-2060 can extend the time before a first blood clot forms in your graft. We will also be carefully watching for any side effects or bleeding problems, as safety is always very important, and whether fewer clots occur overall. To make sure the results are fair, some people will get the new medicine, and others will get a dummy medicine (placebo) – and neither you nor your study doctor will know which you are receiving.

Key takeaways

This study tests a new medicine (MK-2060) to prevent blood clots in dialysis grafts.
It's for adults with serious kidney disease needing haemodialysis.
Participants will receive either the new medicine or a dummy medicine.
The study will track how long it takes for a clot to form and check for side effects.
Regular clinic visits and health checks are part of participating.
Your safety is paramount, and you can withdraw at any time.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults can also take part.

Both men and women can join this study. The researchers want to include different people to see if the new medicine works for everyone.

Full details about who can and cannot join will be discussed with you by the study team. This might include specific health conditions, medications you are taking, or other medical history to make sure the study is safe and right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have serious kidney disease?
Do you currently receive haemodialysis treatment?
Do you have an arteriovenous graft (AVG) or are you planned to receive one?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the new medicine, MK-2060, or a dummy medicine. You won't know which one you are taking, and neither will your study doctor. This is to make sure the results are as fair as possible. You will take the study medicine as directed by the study team.

Throughout the study, you will have regular visits to the clinic. At these visits, the study team will carry out health checks, take blood samples, and ask you questions about how you are feeling and if you have noticed any changes or side effects. They will also monitor your arteriovenous graft very closely to see if any blood clots form.

The total length of your participation in the study will depend on how long it takes for a first blood clot to occur in your graft, or for certain other events to happen. The study team will explain the expected duration and all the visits involved in detail before you decide to join.

Potential risks and benefits

Taking part in this study could offer some potential benefits, although these are not guaranteed. You would receive close medical monitoring and care, and the new medicine (if you receive it) might help prevent blood clots in your graft. However, new medicines can have unknown side effects, and MK-2060 might cause side effects or bleeding. There's also a chance you could receive the dummy medicine which offers no direct medical benefit. Your safety is very important, and you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
Czechia
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Unverified
Greece
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Unverified
Italy
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Unverified
Portugal
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Unverified
Bulgaria
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Unverified
Romania
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Unverified
Sweden

Common questions

What is haemodialysis?

Haemodialysis is a treatment that helps clean your blood when your kidneys can no longer do it properly. It uses a machine to filter waste and extra fluid from your body.

What is an arteriovenous graft (AVG)?

An AVG is a special tube put under your skin, usually in your arm, to create a strong connection for easy and safe access to your bloodstream during haemodialysis.

Why do blood clots form in AVG grafts?

Blood clots can form in AVG grafts for various reasons, including changes in blood flow, damage to the graft, or problems with blood clotting. These clots can stop the graft from working properly.

Will I know if I'm getting the new medicine or the dummy medicine?

No, neither you nor your study doctor will know if you are receiving the new medicine (MK-2060) or the dummy medicine (placebo). This is done to prevent bias and ensure the study results are reliable.

How long will I be in the study?

The length of your time in the study will vary, depending on how your health progresses, specifically regarding your graft. The study team will give you a more precise estimate before you enroll.