Renal Ex Vivo SYN002 Perfusion to Eliminate CMV Transmission

NCT07488481 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 25-5953
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cytomegalovirus (CMV) Infection; Kidney Transplant Recipient

Keywords

Cytomegalovirus; Kidney Transplantation; Ex-vivo organ perfusion

Outcome Measures

Primary Outcomes (1)

• Graft function

  Proportion of patients with a functioning graft at 4 weeks post-transplant defined as no longer needing dialysis at 4 weeks

  4 weeks post-transplant

Secondary Outcomes (7)

• Delayed graft function

  4 weeks post-transplant

• CMV DNAemia 3 months

  3 months post-transplant

• Length of hospital stay

  6 months post-transplant

• Graft survival 3 months

  3 months post-transplant

• Graft survival 6 months

  6 months

Study Arms (1)

EVOP with SYN002

EXPERIMENTAL

Donor kidneys will be treated with SYN002 administered on the EVOP platform. Normothermic perfusion of kidney will be preformed for approximately 4 hours. Prior to transplant, the kidneys will be flushed to remove any residual SYN002 Transplantation and post-operative care will be as per standard of care. The target dose of SYN002 will 850ng/ml; This dose has been shown to be safe and effective in pre-clinical testing. However, we will perform a dose escalation as follows: Cohort 1: 50 ng/ml (n=2); Cohort 2: 150 ng/ml (n=2); Cohort 3: 450 ng/ml (n=2); Cohort 4: 850 ng/ml (n=6).

Drug: SYN002

Interventions

SYN002 DRUG

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

EVOP with SYN002

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Deceased donor
• CMV seropositive (D+)
• Donor kidney meets criteria for transplantation
• Single renal artery (required anatomy to perform EVOP)
• CMV seronegative
• Donor kidney not suitable for transplantation

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network, Toronto General Hospital, Ajmera Transplant Centre

Toronto, Ontario, M5G 2N2, Canada

Location

Related Publications (2)

• Ribeiro RVP, Ku T, Wang A, Pires L, Ferreira VH, Michaelsen V, Ali A, Galasso M, Moshkelgosha S, Gazzalle A, Jeppesen MG, Rosenkilde MM, Liu M, Singer LG, Kumar D, Keshavjee S, Sinclair J, Kledal TN, Humar A, Cypel M. Ex vivo treatment of cytomegalovirus in human donor lungs using a novel chemokine-based immunotoxin. J Heart Lung Transplant. 2022 Mar;41(3):287-297. doi: 10.1016/j.healun.2021.10.010. Epub 2021 Oct 25.

  PMID: 34802874 BACKGROUND

• Kotton CN, Kumar D, Manuel O, Chou S, Hayden RT, Danziger-Isakov L, Asberg A, Tedesco-Silva H, Humar A; Transplantation Society International CMV Consensus Group. The Fourth International Consensus Guidelines on the Management of Cytomegalovirus in Solid Organ Transplantation. Transplantation. 2025 Jul 1;109(7):1066-1110. doi: 10.1097/TP.0000000000005374. Epub 2025 Apr 9. No abstract available.

  PMID: 40200403 BACKGROUND

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Central Study Contacts

Atul Humar, MD, FRCP(C)

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional Phase 1 Single Group Assignment

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 23, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): March 16, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)