SYN002: SYN002, a fusion protein targeting US28, a human cytomegalovirus (CMV) - specific virally encoded receptor expressed on both latent and lytic CMV-infected cells.
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Graft function — 4 weeks post-transplant Proportion of patients with a functioning graft at 4 weeks post-transplant defined as no longer needing dialysis at 4 weeks
Trial sites (1)
Facility
City
Region
Status
University Health Network, Toronto General Hospital, Ajmera Transplant Centre
Toronto
Ontario
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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