[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630500":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":47,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":20,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":73,"whyStopped":20,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.\n\nThe target dose of SYN002 will 850ng\u002Fml; This dose has been shown to be safe and effective in pre-clinical testing. However, we will perform a dose escalation as follows:\n\nCohort 1: 50 ng\u002Fml (n=2); Cohort 2: 150 ng\u002Fml (n=2); Cohort 3: 450 ng\u002Fml (n=2); Cohort 4: 850 ng\u002Fml (n=6).",[13],"Drug: SYN002",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Atul Humar, MD, FRCP(C)","CONTACT","416-340-4241","atul.humar@uhn.ca",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"University Health Network, Toronto General Hospital, Ajmera Transplant Centre","Toronto","Ontario","M5G 2N2","Canada","CA",{"type":36,"coordinates":37},"Point",[38,39],-79.39864,43.70643,{"lat":39,"lon":38},[42],{"name":43,"role":24,"phone":44,"phoneExt":45,"email":46},"Ilona Bahinskaya, MSc, CCRP","416-340-4800","4328","Ilona.Bahinskaya@uhn.ca",{"type":48,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100630500","early-phase-1-renal-ex-vivo-syn002-perfusion-to-eliminate-cmv-transmission-100630500",false,"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","RESPECT-CMV","Recipient Inclusion Criteria:\n\n* Age ≥18 years\n* Listed for kidney transplantation\n* Either CMV seronegative or seropositive\n* Willing to provide written informed consent to take part in the trial\n* Willing and able to return for follow-up visits as scheduled in the protocol\n* Not participating in other interventional trials\n\nRecipient Exclusion Criteria:\n\n* Listed for combined organ transplant (e.g. kidney-pancreas or kidney-liver)\n* Re-transplantation\n* HIV positive\n* Highly sensitized recipient with a PRA \\>=95\n* Planned use of belatacept or alemtuzumab immunosuppression (both non-approved drugs in Canada)\n* Unable or unwilling to comply with study procedures\n\nDonor Inclusion Criteria:\n\n* Deceased donor\n* CMV seropositive (D+)\n* Donor kidney meets criteria for transplantation\n* Single renal artery (required anatomy to perform EVOP)\n\nDonor Exclusion Criteria:\n\n* CMV seronegative\n* Donor kidney not suitable for transplantation","ALL","18 Years",{"count":60,"type":61},12,"ESTIMATED","INTERVENTIONAL",[64],"EARLY_PHASE1","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).",[67,68],"Cytomegalovirus (CMV) Infection","Kidney Transplant Recipient",[70,71,72],"Cytomegalovirus","Kidney Transplantation","Ex-vivo organ perfusion","NOT_YET_RECRUITING","2026-03-17",{"date":76,"type":77},"2026-03-23","ACTUAL",{"date":79,"type":61},"2026-03-16",{"date":81,"type":61},"2027-12-31",{"name":5,"class":6},1]