Renal Ex Vivo SYN002 Perfusion to Eliminate CMV Transmission
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SYN002.
- Who it may be relevant to
- Registry conditions: Cytomegalovirus (CMV) Infection, Kidney Transplant Recipient. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Renal Ex Vivo SYN002 Perfusion to Eliminate CMV Transmission: A Safety Trial in Kidney Transplant Recipients
Overview
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.
Interventions
- 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.
Primary outcome measures
- Graft function [Time frame: 4 weeks post-transplant]
Secondary outcome measures (7)
- Delayed graft function [Time frame: 4 weeks post-transplant]
- CMV DNAemia 3 months [Time frame: 3 months post-transplant]
- Length of hospital stay [Time frame: 6 months post-transplant]
- Graft survival 3 months [Time frame: 3 months post-transplant]
- Graft survival 6 months [Time frame: 6 months]
- CMV DNAemia 6 months [Time frame: 6 months post-transplant]
- CMV disease [Time frame: 6 months post-transplant]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- University Health Network, Toronto General Hospital, Ajmera Transplant Centre — Toronto
Publications
- 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.2021.10.01 PMID 34802874
- 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
Identifiers
NCT: NCT07488481 · 25-5953