[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577786":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":37,"responsibleParty":51,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":25,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":25,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":84,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University of British Columbia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","EXPERIMENTAL","Patients will withdraw from immunosuppressant after 6 months post dialysis initiation",[13],"Drug: Prevention of Allosensitization",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2","ACTIVE_COMPARATOR","Patients will withdraw from immunosuppressant after 24 months post dialysis initiation",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Prevention of Allosensitization","This study evaluates the impact of two different durations of immunosuppressive therapy on kidney transplant patients who return to dialysis after a failed transplant. One group will continue immunosuppressive therapy for two years, while the other will stop the therapy six months after starting dialysis. The goal is to determine if continuing immunosuppression can reduce the risk of allosensitization and improve outcomes, compared to stopping the therapy earlier.",[9,15],null,[27,32],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Gurvir Thind","CONTACT","604-441-1102","gthind@providencehealth.bc.ca",{"name":33,"role":29,"phone":34,"phoneExt":35,"email":36},"Breanna Riou-Green","604-682-2344","64706","briougreen@providencehealth.bc.ca",[38],{"facility":39,"status":25,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":25},"Kidney Transplant Research","Vancouver","British Columbia","V6Z1Y6","Canada","CA",{"type":46,"coordinates":47},"Point",[48,49],-123.11934,49.24966,{"lat":49,"lon":48},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","John Gill","Transplant Nephrologist",[56],{"name":57,"class":58},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV","100577786","prevent-allosensitization-in-patients-who-have-failed-a-first-renal-transplant-part-100577786",false,"NCT06802822","Prevent Allosensitization in Patients Who Have Failed a First Renal Transplant (PART)","The PART PILOT STUDY: a Pilot Study to Inform the Feasibility of a Definitive Prospective Interventional Study to Prevent Allosensitization in Patients Who Have Failed a First Renal Transplant","Inclusion Criteria:\n\n* Patients ≥ 19 years old with a failed first kidney transplant and planned dialysis start date.\n\nExclusion Criteria:\n\n* Previous extra-renal organ transplant, or more than one previous kidney transplant\n* Not prescribed tacrolimus or cyclosporine at the time of transplant failure\n* Active infection or cancer that precludes IMSN, or non-transplant indication to continue IMSN\n* Receipt of an HLA identical donor transplant kidney with low risk for sensitization\n* Patients without archived donor samples to determine eplet mismatch and donor specific antibodies\n* Planned nephrectomy of the failed allograft\n* Graft survival of ≤ 12 months due to rejection\n* Designated as non-repeat transplant candidates by their transplant center or cPRA ≥ 90% at the time of enrollment in whom further increase in cPRA may permanently preclude repeat transplantation\n* Planned living donor transplant or planned move away from study center","ALL","19 Years",{"count":69,"type":70},96,"ESTIMATED","INTERVENTIONAL",[73],"NA","Kidney transplant is often the best treatment for people with kidney failure, but transplanted kidneys don't always last a lifetime. Many transplanted kidneys fail within 12 years, leaving patients needing dialysis or another transplant. One major issue is something called \"allosensitization,\" which happens when the immune system attacks the donated kidney due to foreign markers on the kidney. This makes it harder to match a patient with another donor kidney in the future.\n\nTo try to prevent this, patients are given immunosuppressants (drugs that weaken the immune system) after a transplant to stop the immune system from attacking the new kidney. However, after a kidney transplant fails and patients return to dialysis, there's no clear evidence that continuing immunosuppressants helps prevent allosensitization. Plus, these drugs have serious risks, including infections, heart disease, and even cancer.\n\nThe PART study is a pilot study designed to explore whether continuing immunosuppression after a failed transplant for two years (instead of stopping after six months) can lower the risk of allosensitization and whether it is safe to do so. This pilot will also gather data that will be used for a larger trial in the future.\n\nThe study will be done at 12 different research centers, and around 96 patients will be enrolled in the pilot trial. The ultimate goal is to better understand if continuing immunosuppressants after transplant failure can make a difference, and whether it's safe enough to proceed to a larger, more definitive trial.",[76,77,78],"Kidney Transplant","Kidney Transplant Failure","Immunosuppresion",[80,81,82,83],"kidney transplant","kidney transplant failure","immunosuppression","sensitization","NOT_YET_RECRUITING","2025-01-24",{"date":87,"type":88},"2025-01-31","ACTUAL",{"date":90,"type":70},"2025-01",{"date":92,"type":70},"2027-12",{"name":5,"class":6},1]