Not Yet RecruitingEarly Phase 1

Renal Ex Vivo SYN002 Perfusion to Eliminate CMV Transmission

Canada12 participantsStarted 2026-03-16

Plain-language summary

Donor organs often carry latent Cytomegalovirus (CMV) infection that may be transmitted to the recipient. The goal of this clinical trial is to determine the safety of SYN002 treatment during Ex-Vivo Organ Perfusion (EVOP) in clinical kidney transplantation. Donor kidneys will be treated on the EVOP system with SYN002 in order to decrease the burden of latent CMV in the organ and mitigate the transmission of cytomegalovirus (CMV).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Recipient Inclusion Criteria: * Age ≥18 years * Listed for kidney transplantation * Either CMV seronegative or seropositive * Willing to provide written informed consent to take part in the trial * Willing and able to return for follow-up visits as scheduled in the protocol * Not participating in other interventional trials Recipient Exclusion Criteria: * Listed for combined organ transplant (e.g. kidney-pancreas or kidney-liver) * Re-transplantation * HIV positive * Highly sensitized recipient with a PRA \>=95 * Planned use of belatacept or alemtuzumab immunosuppression (both non-approved drugs in Canada) * Unable or unwilling to comply with study procedures Donor Inclusion Criteria: * Deceased donor * CMV seropositive (D+) * Donor kidney meets criteria for transplantation * Single renal artery (required anatomy to perform EVOP) Donor Exclusion Criteria: * CMV seronegative * Donor kidney not suitable for transplantation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Graft function

Timeframe: 4 weeks post-transplant

Trial details

NCT IDNCT07488481

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-16

Contact for this trial

Atul Humar, MD, FRCP(C)

416-340-4241 atul.humar@uhn.ca

View on ClinicalTrials.gov More Cytomegalovirus (CMV) Infection trials