NCT07488481

Renal Ex Vivo SYN002 Perfusion to Eliminate CMV Transmission

Renal Ex Vivo SYN002 Perfusion to Eliminate CMV Transmission: A Safety Trial in Kidney Transplant Recipients

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Cytomegalovirus (CMV) is the most common viral infection in transplant recipients and has major impacts on patient outcomes. It can cause fever, pneumonia, gastrointestinal disease, and lead to rejection of the kidney. To prevent this, transplant recipients receive prolonged antiviral drugs. This leads to significant drug toxicity and cost, and is often not successful. The risk of CMV is much higher if the donor organ carries latent CMV inside it (approximately 50-70% of donor organs). A much better and safer strategy would therefore be to try to eliminate the latent virus from the donor organ prior to transplantation. Ex Vivo Organ Perfusion (EVOP) is a common method of donor organ preservation and treatment which allows donor organs to be treated for several hours under close to physiological conditions. The investigators propose a study in which kidneys will be treated prior to transplantation on the EVOP platform in order to decrease latent CMV. SYN002 is a novel compound that binds to cells that are latently infected with CMV and is internalized and kills those specific cells. This pilot study will involve 12 kidney transplant patients, who are receiving a kidney known to have latent CMV. The kidney will be treated with SYN002 on the EVOP system prior to transplantation.

Conditions

• Cytomegalovirus (CMV) Infection
• Kidney Transplant Recipient

Interventions

Type	Name	Description
DRUG	SYN002	SYN002, a fusion protein targeting US28, a human cytomegalovirus (CMV) - specific virally encoded receptor expressed on both latent and lytic CMV-infected cells.

Timeline

• Start date: 2026-03-16
• Primary completion: 2027-03-16
• Completion: 2027-12-31
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: Canada