[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05106387":3,"trial-entities:NCT05106387":182,"trial-summary:NCT05106387":187},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":17,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":36,"secondary_outcomes":42,"sex":88,"minimum_age":89,"maximum_age":90,"healthy_volunteers":15,"eligibility_criteria":91,"std_ages":95,"locations":98,"central_contacts":170,"overall_officials":176,"references":180,"see_also_links":181},"NCT05106387","R5459-RT-1956","An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant","A Noninterventional Extension Study for Patients Treated in Study R5459-RT-1944 With Vonsetamig (BCMA x CD3 Bispecific Antibody) Who Receive a Kidney Transplant","RECRUITING","2028-02-23","2026-07","2026-07-20","2023-10-19","Regeneron Pharmaceuticals","INDUSTRY",false,"The main purpose of this study is to continue to see how vonsetamig works in the body and to monitor the outcomes after kidney transplant for participants previously treated in the R5459-RT-1944 study (NCT05092347).\n\nNo study drug will be given during this study.",null,[19],"Chronic Kidney Disease (CKD)",[21],"Kidney Transplant","OBSERVATIONAL",[],{"count":25,"type":26},20,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":34},"DRUG","Noninterventional","No investigational treatment will be given in this noninterventional extension study",[33],"Vonsetamig in study R5459-RT-1944",[35],"REGN5459",[37,40],{"measure":38,"timeFrame":39},"Incidence of Adverse Events","Up to 12 months post-kidney transplant",{"measure":41,"timeFrame":39},"Incidence of Serious Adverse Events",[43,47,49,51,54,57,59,63,67,70,72,75,78,81,83,86],{"measure":44,"description":45,"timeFrame":46},"Incidence of biopsy-proven kidney allograft rejection","Responsiveness to therapy by 12 months of each of the following types of biopsy-proven kidney allograft rejection according to Banff classification:\n\n* Active antibody-mediated rejection (AMR) (Category 2)\n* Chronic active AMR (Category 2)\n* Acute t-cell-mediated rejection (TCMR) (Category 4)\n* Chronic active TCMR (Category 4)","Up to 12 Months",{"measure":48,"description":45,"timeFrame":46},"Time to diagnosis of biopsy-proven kidney allograft rejection",{"measure":50,"description":45,"timeFrame":46},"Responsiveness to therapy by 12 months of biopsy-proven kidney allograft rejection",{"measure":52,"description":53,"timeFrame":46},"Incidence of graft loss","Incidence of graft loss (defined as becoming dialysis-dependent) by 12 months",{"measure":55,"description":56,"timeFrame":46},"Time to graft loss","Time to graft loss (defined as becoming dialysis-dependent) by 12 months",{"measure":58,"timeFrame":46},"Change in estimated glomerular filtration rate (eGFR) over time",{"measure":60,"description":61,"timeFrame":62},"Incidence of delayed graft function","Incidence of delayed graft function (defined as the use of dialysis within 7 days posttransplant)","Up to Day 7",{"measure":64,"description":65,"timeFrame":66},"Percent Change in anti-HLA alloantibodies","Percent Change in anti-HLA alloantibodies (SAB assay) compared with pretransplant levels at 2, 3, 6, and 12 months, and at the time of suspected clinical episodes of allograft rejection","Up to 12 months",{"measure":68,"description":69,"timeFrame":66},"Mean Fluorescence Intensity Change in anti-HLA alloantibodies","Mean Fluorescence Intensity (MFI) Change in anti-HLA alloantibodies (SAB assay) compared with pretransplant levels at 2, 3, 6, and 12 months, and at the time of suspected clinical episodes of allograft rejection",{"measure":71,"timeFrame":46},"Change in Calculated panel-reactive antibody (cPRA) over time",{"measure":73,"description":74,"timeFrame":46},"Percent Change in donor-specific anti-HLA alloantibodies","Percent Change in donor-specific anti-HLA alloantibodies compared with recipient pre-transplant anti-HLA alloantibody levels",{"measure":76,"description":77,"timeFrame":46},"Mean Fluorescence Intensity Change in donor-specific anti-HLA alloantibodies","Mean Fluorescence Intensity Change in donor-specific anti-HLA alloantibodies compared with recipient pre-transplant anti-HLA alloantibody levels",{"measure":79,"description":80,"timeFrame":46},"Incidence of de novo anti-HLA alloantibody development","Cumulative incidence of de novo anti-HLA alloantibody development by SAB assay by 12 months",{"measure":82,"timeFrame":46},"Serum Concentrations of Ig classes (IgG, IgA, and IgM) over time",{"measure":84,"description":85,"timeFrame":46},"Percent change from baseline of circulating serum concentrations of Ig classes","Percent change from baseline of circulating serum concentrations of Ig classes (IgG, IgA, and IgM)",{"measure":87,"timeFrame":46},"Serum Concentration of vonsetamig","ALL","18 Years","70 Years",{"inclusion":92,"exclusion":93,"raw_text":94},[],[],"Inclusion Criteria:\n\n1. Received at least 1 dose of treatment with vonsetamig in study R5459-RT-1944 \\[NCT05092347\\].\n2. Received after acceptable crossmatching, a kidney transplant while enrolled in study R5459-RT-1944\n3. Willing and able to comply with clinic visits and study-related procedures\n4. Provide informed consent signed by study patient or legally acceptable representative\n\nExclusion Criteria:\n\n1.There are no exclusion criteria for this study.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply",[96,97],"ADULT","OLDER_ADULT",[99,108,115,122,131,139,147,155,162],{"facility":100,"status":8,"city":101,"state":102,"zip":103,"country":104,"geoPoint":105},"Cedars-Sinai Medical Center","Los Angeles","California","90048","United States",{"lat":106,"lon":107},34.05223,-118.24368,{"facility":109,"status":8,"city":110,"state":102,"zip":111,"country":104,"geoPoint":112},"University of California Irvine","Orange","92868",{"lat":113,"lon":114},33.78779,-117.85311,{"facility":116,"status":8,"city":117,"state":102,"zip":118,"country":104,"geoPoint":119},"Connie Frank Transplant Center at UCSF","San Francisco","94143",{"lat":120,"lon":121},37.77493,-122.41942,{"facility":123,"status":124,"city":125,"state":126,"zip":127,"country":104,"geoPoint":128},"Yale University of Medicine","COMPLETED","New Haven","Connecticut","06520",{"lat":129,"lon":130},41.30815,-72.92816,{"facility":132,"status":8,"city":133,"state":134,"zip":135,"country":104,"geoPoint":136},"Comprehensive Transplant Center","Chicago","Illinois","60611",{"lat":137,"lon":138},41.85003,-87.65005,{"facility":140,"status":8,"city":141,"state":142,"zip":143,"country":104,"geoPoint":144},"John Hopkins Hospital","Baltimore","Maryland","21224",{"lat":145,"lon":146},39.29038,-76.61219,{"facility":148,"status":8,"city":149,"state":150,"zip":151,"country":104,"geoPoint":152},"University of Minnesota","Minneapolis","Minnesota","55455",{"lat":153,"lon":154},44.97997,-93.26384,{"facility":156,"status":124,"city":157,"state":157,"zip":158,"country":104,"geoPoint":159},"New York University Langone Health","New York","10016",{"lat":160,"lon":161},40.71427,-74.00597,{"facility":163,"status":8,"city":164,"state":165,"zip":166,"country":104,"geoPoint":167},"Penn Transplant Institute","Philadelphia","Pennsylvania","19104",{"lat":168,"lon":169},39.95238,-75.16362,[171],{"name":172,"role":173,"phone":174,"email":175},"Clinical Trials Administrator","CONTACT","844-734-6643","clinicaltrials@regeneron.com",[177],{"name":178,"affiliation":13,"role":179},"Clinical Trial Management","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":183,"biomarkers":186},[184,185],"Chronic Kidney Disease","Kidney Transplantation",[],{"nct_id":4,"found":188,"summary":189,"prompt_version":199},true,{"design":190,"status":191,"heading":192,"summary":193,"follow_up":194,"word_count":195,"commitments":196,"compensation":197,"drugs_mentioned":198},"This is an observational study, meaning no new treatment will be given. It plans to enroll 20 participants.","completed","Observational Study for Patients Receiving a Kidney Transplant After Vonsetamig Treatment","This study is for adults aged 18 to 70 who previously participated in the R5459-RT-1944 study and received at least one dose of vonsetamig, and then had a kidney transplant. The main goal is to continue observing how vonsetamig affects the body and to track your health outcomes after your kidney transplant. No new medication will be given during this study. Researchers will be looking at any side effects (adverse events) you experience for up to 12 months after your kidney transplant. The study plans to include 20 participants, but its current recruitment status is unclear.","Participants will be followed for up to 12 months after their kidney transplant to monitor adverse events.",96,"You would need to be willing and able to attend clinic visits and follow study-related procedures. These observations will continue for up to 12 months after your kidney transplant.","Not stated in the trial record.",[],"v2"]