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 range18 Years

SexALL

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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

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