[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646192":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":59,"collaborators":20,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":20,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":20,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":82,"whyStopped":20,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Xeno Holdings (US), LLC dba ChoironeX","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Porcine Thymokidney","EXPERIMENTAL","Porcine Thymokidney transplanted into patients with End Stage Renal Disease",[13],"Biological: ChoironeX GalKO Porcine Thymokidney",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","ChoironeX GalKO Porcine Thymokidney","A constructed thymokidney from a genetically modified porcine donor will be preserved, packaged, transported and transplanted into the study subject at the study site in the same fashion as a human donor kidney. The thymokidney will remain in the subject throughout the subject's lifetime, or until thymokidney explant.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Anh Nyugen, MD","ChoironeX \u002F Our Hybrid Concepts LLC","STUDY_DIRECTOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Lindsey Dickerson","CONTACT","+1 (347) 602-0721","ldickerson@nefro-avillion.com",{"name":33,"role":29,"phone":20,"phoneExt":20,"email":34},"Gemma Hodgson","ghodgson@nefro-avillion.com",[36,51],{"facility":37,"status":20,"city":38,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Study Site 2","New York","10016","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-74.00597,40.71427,{"lat":46,"lon":45},[49],{"name":50,"role":29,"phone":20,"phoneExt":20,"email":20},"Research Coordinator",{"facility":52,"status":20,"city":38,"state":38,"zip":53,"country":40,"countryCode":41,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},"Study Site 1","10032",{"type":43,"coordinates":55},[45,46],{"lat":46,"lon":45},[58],{"name":50,"role":29,"phone":20,"phoneExt":20,"email":20},{"type":60,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100646192","phase-1-study-of-choironex-galko-porcine-thymokidney-xenotransplantation-in-end-stage-renal-disease-100646192",false,"NCT07696962","Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease","Phase 1 Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease","Inclusion Criteria\n\n* ESRD receiving hemodialysis or peritoneal dialysis for ≥6 months\n* Eligible for kidney transplantation per site criteria\n* \\\u003C50% likelihood of receiving a standard deceased-donor kidney transplant within 12 months\n* Blood type and immunologic compatibility with study transplant confirmed by testing\n* EBV seropositive\n* Up to date on recommended vaccinations for immunocompromised individuals\n* Willing to use protocol-required contraception\n* Able to provide informed consent and comply with lifelong follow-up\n\nExclusion Criteria:\n\n* Requirement for multi-organ transplantation\n* Living donor available who is ABO-incompatible\n* Kidney disease with high risk of post-transplant recurrence\n* Polycystic kidney disease without prior native nephrectomy\n* Unable or unwilling to comply with study procedures\n* History of non-adherence to medical treatment\n* Identified as vulnerable by psychological assessment\n* Significant uncontrolled psychiatric illness\n* Inadequate social support or caregiver unavailable\u002Funwilling\n* Current drug or alcohol misuse\n* Serious non-renal illness with life expectancy \\\u003C1 year\n* BMI \\\u003C16 or \\>35 kg\u002Fm²\n* Known hypercoagulable disorder\n* Uncontrolled hypertension or hemodynamic instability at enrollment\n* Clinically significant cardiovascular disease, including poorly controlled coronary artery disease, reduced left ventricular function, recent myocardial infarction or cardiac intervention, or clinically significant arrhythmia requiring treatment\n* Serious liver disease or impaired liver function\n* Diabetes mellitus with poor glycemic control (HbA1c \\>10%)\n* Active infection at time of transplantation\n* Positive serology for hepatitis B, hepatitis C, or HIV\n* Current, active, or untreated tuberculosis\n* Malignancy within 5 years prior to enrollment, excluding adequately treated non-melanoma skin cancer\n* Current systemic immunosuppressive therapy (excluding permitted corticosteroids)\n* Participation in another interventional drug trial within 60 days prior to enrollment\n* Pregnant or breastfeeding\n* Known severe hypersensitivity to a required study medication with no acceptable alternative","ALL","18 Years","70 Years",{"count":72,"type":73},4,"ESTIMATED","INTERVENTIONAL",[76],"PHASE1","The goal of this clinical trial is to learn if a GalKO Porcine Thymokidney can maintain renal function, without the need for dialysis, after transplantation into adult subjects with End Stage Renal Disease.",[79],"End Stage Renal Disease",[81],"Kidney, Porcine, Xeno-Transplant","NOT_YET_RECRUITING","2026-07-08",{"date":85,"type":86},"2026-07-10","ACTUAL",{"date":88,"type":73},"2026-07-01",{"date":90,"type":73},"2028-09-30",{"name":5,"class":6},2]