[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100331134":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":82,"collaborators":21,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":21,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":21,"enrollmentInfo":95,"targetDuration":21,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":43,"whyStopped":21,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Stanford University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Immune tolerance, Kidney transplantation","EXPERIMENTAL","Intervention: HLA matched living donor recipients of a functioning kidney transplant graft at one year will receive hematopoietic cell transplantation and Total lymphoid irradiation. The intervention is intended to induce immune tolerance such as to allow withdrawal of the immunosuppressive drugs. Immune tolerance is achieved through the development of donor\u002Frecipient mixed chimerism following combined kidney and hematopoietic stem cell transplantation from the living donor.",[13,14],"Biological: Hematopoietic cell transplantation","Radiation: Total Lymphoid irradiation",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"BIOLOGICAL","Hematopoietic cell transplantation","Transplantation of hematopoietic stem cells from living donor.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"RADIATION","Total Lymphoid irradiation","Total lymphoid irradiation is used as part of the conditioning regimen for the hematopoietic stem cell transplant.",[9],[28],{"name":29,"affiliation":5,"role":30},"Stephan Stephan, MD, MS","PRINCIPAL_INVESTIGATOR",[32,36],{"name":29,"role":33,"phone":34,"phoneExt":21,"email":35},"CONTACT","6504986189","sbusque@stanford.edu",{"name":37,"role":33,"phone":38,"phoneExt":21,"email":39},"Carlos Lazarte, BA","650-885-9488","kevinly@stanford.edu",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Stanford University Medical Center","RECRUITING","Palo Alto","California","94304","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-122.14302,37.44188,{"lat":53,"lon":52},[56,59,62,64,66,68,70,72,74,76,78,80],{"name":57,"role":33,"phone":34,"phoneExt":21,"email":58},"Stephan Busque, MD MS","stephan.busque@stanford.edu",{"name":60,"role":61,"phone":21,"phoneExt":21,"email":21},"John Scandling, MD","SUB_INVESTIGATOR",{"name":63,"role":30,"phone":21,"phoneExt":21,"email":21},"Everett Meyer, MD",{"name":65,"role":30,"phone":21,"phoneExt":21,"email":21},"Robert Lowsky, MD",{"name":67,"role":61,"phone":21,"phoneExt":21,"email":21},"Hoppe Richard, MD",{"name":69,"role":61,"phone":21,"phoneExt":21,"email":21},"Thomas A Pham, MD",{"name":71,"role":30,"phone":21,"phoneExt":21,"email":21},"Stephan Busque, MD",{"name":73,"role":61,"phone":21,"phoneExt":21,"email":21},"Colin Lenihan, MD",{"name":75,"role":61,"phone":21,"phoneExt":21,"email":21},"Michael Binkley, MD",{"name":77,"role":61,"phone":21,"phoneExt":21,"email":21},"Kevin Sheehan, PhD",{"name":79,"role":61,"phone":21,"phoneExt":21,"email":21},"Subramanian Sivarajan, MD",{"name":81,"role":61,"phone":21,"phoneExt":21,"email":21},"Marc L Melcher, MD",{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"SPONSOR_INVESTIGATOR","Stephan Busque","Professor for Surgery","100331134","phase-1-delayed-blood-stem-transplantation-in-hla-matched-kidney-transplant-recipients-to-eliminate-immunosuppressive-drugs-100331134",false,"NCT03591302","Delayed Blood Stem Transplantation in HLA Matched Kidney Transplant Recipients to Eliminate Immunosuppressive Drugs.","Total Lymphoid Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+ and T-cell Transfusion to Withdraw Immunosuppressive Drugs From Recipients of a Previous HLA Matched Living Donor Kidney Transplantation .","Inclusion Criteria:\n\n1. All consenting adults of age 18 years and older with previous HLA matched sibling living donor renal transplants who still have their HLA- matched kidney donor available, and who have no history of acute or chronic rejection.\n2. Patients who agree to participate in the study and sign an Informed Consent\n3. The HLA-matched donor meets the Stanford Bone Marrow Transplant criteria for stem cell donation, agrees to participate and has signed an Informed Consent.\n4. The pair is confirmed to be HLA-matched (2 haplo type match) as determined by the histocompatibility laboratory at Stanford.\n5. Patients who have no known contraindication to the administration of rabbit ATG or radiation\n6. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 18 months post transplant.\n\nExclusion Criteria:\n\n1. Known allergy to ATG or a known allergy to rabbit proteins.\n2. History of malignancy with the exception of non-melanoma skin malignancies.\n3. Pregnant women or nursing mothers.\n4. Serological evidence of HIV, Hepatitis B (HepBsAg+) or Hepatitis C infection.\n5. Leukopenia (with a white blood cell count \\\u003C 3000\u002Fmm3) or thrombocytopenia (platelet count \\\u003C 100,000\u002Fmm3)\n6. Previous history of acute or chronic rejection of the kidney transplant or recurrence of the original disease.\n7. Screening kidney biopsy demonstrating acute or chronic rejection, recurrence of original disease or interstitial fibrosis\u002FTubular Atrophy (IF\u002FTA) score greater than 1.","ALL","18 Years",{"count":96,"type":97},25,"ESTIMATED","INTERVENTIONAL",[100],"PHASE1","The study will determine whether patients with functioning Human Leukocyte Antigen (HLA) matched kidney transplants for at least one year and who want to discontinue immunosuppressive drugs can be treated with Total Lymphoid Irradiation (TLI) and rabbit Anti-Thymocyte Globulin (rATG) and an HLA matched donor hematopoietic progenitor cell infusion such that their drugs are successfully withdrawn while maintaining normal renal function.",[103],"Immune Tolerance",[105,106],"Kidney Transplantation","Blood Stem Cell Transplantation","2026-06-29",{"date":109,"type":110},"2026-07-01","ACTUAL",{"date":112,"type":110},"2024-02-02",{"date":114,"type":97},"2028-10-01",{"name":84,"class":6},1]