Not yet recruitingEARLY_PHASE1INTERVENTIONAL

Renal Ex Vivo SYN002 Perfusion to Eliminate CMV Transmission

This study is testing a new way to make kidney transplants safer. Many donated kidneys carry a common virus called Cytomegalovirus (CMV), which can cause serious health issues for the patient after transplant and even lead to the body rejecting the new kidney. Currently, patients take strong antiviral medicines for a long time to prevent this, which can have side effects. Researchers are exploring if treating the donor kidney with a medicine called SYN002 before it's transplanted can remove the CMV directly from the organ. This early-stage study will test the safety of this new treatment method, hoping to reduce the risk of CMV infection and improve outcomes for kidney transplant patients.

At a glance

Status

Not yet recruiting

Phase

EARLY_PHASE1

Sponsor

University Health Network, Toronto

Enrolment target

Start

16 Mar 2026

Estimated completion

31 Dec 2027

Cytomegalovirus (CMV) Infection Kidney Transplant Recipient

What is this study about?

When someone receives a new kidney, there's a risk of getting a common virus called Cytomegalovirus (CMV). This virus is often hidden in the donated organ itself and can cause serious health problems for the person getting the transplant, like fever, lung issues, stomach problems, and even lead to the body rejecting the new kidney. To stop this from happening, transplant patients usually need to take strong anti-viral medicines for a long time. However, these medicines can have side effects and don’t always work perfectly.

This study is trying a new approach. Instead of treating the patient after the transplant, we want to see if we can treat the donated kidney beforehand. We're using a special process called 'Ex-Vivo Organ Perfusion' (EVOP), which means the kidney is kept outside the body in a special system for a few hours. During this time, a new medicine called SYN002 is added. SYN002 is designed to find and destroy the cells in the kidney that are hiding the CMV virus.

By getting rid of the CMV from the donor kidney before it's even transplanted, the hope is to significantly reduce the risk of the recipient getting sick from CMV. This could mean less need for strong medicines after the transplant, fewer side effects, and a better chance of the new kidney working well for a long time. This is an early-stage study focusing on the safety of this new treatment.

Key takeaways

Tests a new way to remove the CMV virus from donated kidneys before transplant.
Aims to make kidney transplants safer and reduce post-transplant infections.
Uses a special machine (EVOP) to treat the kidney with a new medicine (SYN002).
Could mean fewer strong anti-CMV medicines for patients after transplant.
This is an early safety study with 12 patients only.

Who may be eligible?

This study is looking for people who are at least 18 years old and are waiting for a kidney transplant. You can be eligible whether you've had CMV before or not. You'll need to be willing to give your permission to join the study and be able to come to all the follow-up appointments.

You won't be able to join if you're having a transplant of more than one organ (like a kidney and pancreas together), if you've had a kidney transplant before, or if you have HIV. Also, if you need certain types of medicines to stop your body rejecting the kidney that are not approved in Canada, or if you have a very strong immune reaction to many tissues, you wouldn't be able to take part.

For the donated kidney, it needs to come from someone who has sadly passed away and who was known to have CMV. The kidney must be otherwise suitable for transplant and have a single main artery for the treatment to work properly.

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?
Are you on the waiting list for a single kidney transplant?
Are you willing and able to attend all follow-up appointments?
Do you *not* have HIV?
Have you *not* had a kidney transplant before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main difference will happen before your kidney transplant. The donated kidney that is suitable for you and has CMV will be treated with the SYN002 medicine using a special machine called an EVOP system. This treatment takes place outside of your body, before the surgery. After the transplant, you will receive standard care, but the research team will closely monitor you to see how the treated kidney is doing and to check for any signs of CMV or other issues. You will have a series of follow-up visits to assess your health and the kidney's function, which will be part of the study. The total duration of your participation in terms of follow-up will be explained by the study team.

Potential risks and benefits

The potential benefit of taking part is that the donated kidney you receive will have been treated to reduce the CMV virus within it, which could lower your risk of developing CMV disease after the transplant. This might lead to you needing fewer strong anti-viral medications in the long run. Like any medical procedure or trial, there are potential risks, though in this study, the treatment is applied to the donated organ before it reaches you, meaning direct exposure to the new medicine happens outside of your body. However, the exact impact on the kidney and on you after transplantation is what the safety part of this early study aims to find out. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

University Health Network, Toronto General Hospital, Ajmera Transplant Centre
Verified postcode
Toronto, Canada

Common questions

What is CMV and why is it a problem for transplant patients?

CMV is a common virus that can be hidden in donated organs. After a transplant, it can cause infections and make it harder for your body to accept the new kidney.

How is this study different from usual kidney transplants?

Normally, patients take medicine after transplant for CMV. In this study, the donated kidney itself is treated with a special medicine for CMV before it's transplanted into your body.

What is SYN002?

SYN002 is a new medicine being tested. It's designed to find and destroy the virus-infected cells within the donated kidney before it’s transplanted.

Will I still need to take medicines after the transplant if I participate?

You will still need to take medicines to prevent your body from rejecting the new kidney. The hope is that you might need less strong anti-CMV medicines, but this is an early study.

Is this treatment safe?

This is an early-stage study, so a key goal is to find out if the SYN002 treatment on the kidney is safe. The treatment is done outside the body before the transplant.

How to find out more

Atul Humar, MD, FRCP(C)

atul.humar@uhn.ca 416-340-4241 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.