[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06832410":3,"trial-entities:NCT06832410":128,"trial-summary:NCT06832410":133},{"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":15,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":38,"secondary_outcomes":42,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":58,"eligibility_criteria":59,"std_ages":68,"locations":71,"central_contacts":119,"overall_officials":125,"references":126,"see_also_links":127},"NCT06832410","VX23-880-102","An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes With a Kidney Transplant","A Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of VX-880 in Subjects With Type 1 Diabetes With a Kidney Transplant","RECRUITING","2027-09-17","2026-03","2026-03-23","2025-03-31","Vertex Pharmaceuticals Incorporated","INDUSTRY",null,"This study will evaluate the efficacy, safety, and tolerability of VX-880 in participants with Type 1 Diabetes (TID) with a kidney transplant.",[18,19],"Type 1 Diabetes","Kidney Transplant",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE3",{"count":26,"type":27},10,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"BIOLOGICAL","Biological\u002FVaccine","Infused into the hepatic portal vein.",[34],"VX-880",[36,37],"Zimislecel","Formerly known as STx-02",[39],{"measure":40,"timeFrame":41},"Proportion of Participants who are Insulin Independent","At 1 year After VX-880 infusion",[43,46,49,52],{"measure":44,"timeFrame":45},"Proportion of participants who achieve insulin independence and are insulin independent 12 months later","1 year after achieving insulin independence",{"measure":47,"timeFrame":48},"Change from Baseline in glycosylated hemoglobin (HbA1c)","Baseline, At 1 year After VX-880 infusion",{"measure":50,"timeFrame":51},"Proportion of Participants who Maintain Insulin Independence for at least 1 year","From VX-880 infusion to End of Study (up to 2 years)",{"measure":53,"timeFrame":54},"Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)","From Signing of informed consent to End of Study (up to 2 years)","ALL","18 Years","65 Years",false,{"inclusion":60,"exclusion":64,"raw_text":67},[61,62,63],"Clinical history of T1D with greater than or equal to (≥)5 years of insulin dependence","Taking a stable immunosuppression regimen of tacrolimus and mycophenolate mofetil, mycophenolate sodium, or sirolimus for at least 4 weeks","Consistent use of continuous glucose monitor (CGM) for at least 4 weeks before Screening and willingness to use CGM for the duration of the study",[65,66],"Prior islet cell transplant, organ transplant (other than kidney transplant), or cell therapy, except prior pancreatic graft that failed within the first 4 weeks","Participants had \\>1 kidney transplant procedure","Key Inclusion Criteria:\n\n* Clinical history of T1D with greater than or equal to (≥)5 years of insulin dependence\n* Taking a stable immunosuppression regimen of tacrolimus and mycophenolate mofetil, mycophenolate sodium, or sirolimus for at least 4 weeks\n* Consistent use of continuous glucose monitor (CGM) for at least 4 weeks before Screening and willingness to use CGM for the duration of the study\n\nKey Exclusion Criteria:\n\n* Prior islet cell transplant, organ transplant (other than kidney transplant), or cell therapy, except prior pancreatic graft that failed within the first 4 weeks\n* Participants had \\>1 kidney transplant procedure\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply.",[69,70],"ADULT","OLDER_ADULT",[72,81,88,96,103,109,116],{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":77,"geoPoint":78},"Perelman Center for Advanced Medicine - Endocrinology","Philadelphia","Pennsylvania","19104","United States",{"lat":79,"lon":80},39.95238,-75.16362,{"facility":82,"status":8,"city":83,"state":75,"zip":84,"country":77,"geoPoint":85},"Montefiore Clinical and Translational Research Center - Endocrinology","Pittsburgh","15213",{"lat":86,"lon":87},40.44062,-79.99589,{"facility":89,"status":8,"city":90,"state":91,"zip":92,"country":77,"geoPoint":93},"UW University Hospital - Endocrinology","Madison","Wisconsin","53792",{"lat":94,"lon":95},43.07305,-89.40123,{"facility":97,"status":8,"city":98,"country":99,"geoPoint":100},"Toronto General Hospital - Endocrinology","Toronto","Canada",{"lat":101,"lon":102},43.70643,-79.39864,{"facility":104,"status":8,"city":105,"country":99,"geoPoint":106},"Vancouver General Hospital - Gordon and Leslie Diamond Health Care Centre","Vancouver",{"lat":107,"lon":108},49.24966,-123.11934,{"facility":110,"status":8,"city":111,"country":112,"geoPoint":113},"King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology","Riyadh","Saudi Arabia",{"lat":114,"lon":115},24.68773,46.72185,{"facility":117,"status":8,"city":111,"country":112,"geoPoint":118},"King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology",{"lat":114,"lon":115},[120],{"name":121,"role":122,"phone":123,"email":124},"Medical Information","CONTACT","617-341-6777","medicalinfo@vrtx.com",[],[],[],{"nct_id":4,"conditions":129,"biomarkers":132},[130,131],"Kidney Transplantation","Type 1 Diabetes Mellitus",[],{"nct_id":4,"found":134,"summary":135,"prompt_version":143},true,{"design":136,"status":137,"heading":6,"summary":138,"follow_up":136,"word_count":139,"commitments":140,"compensation":141,"drugs_mentioned":142},"Not specified.","completed","{\n   \"Study of VX-880 for Type 1 Diabetes with a Kidney Transplant\",\n   \"This study is looking at a treatment called VX-880 for people who have Type 1 Diabetes (T1D) and have also had a kidney transplant. VX-880 is given by infusion into a vein in the liver. The main goal is to see if VX-880 can help participants become independent of insulin one year after receiving the treatment. Researchers will also check how safe VX-880 is and how well people tolerate it. You might be able to join if you are between 18 and 65 years old, have had T1D for at least 5 years and rely on insulin, and are on a stable regimen of certain immunosuppression medicines (like tacrolimus and mycophenolate). The study plans to enroll 10 participants, but its current status is unclear.\",\n  \"design\": \"This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 10 participants.\",\n  \"commitments\": \"You would need to have a clinical history of Type 1 Diabetes with at least 5 years of insulin dependence and be on a stable immunosuppression regimen for at least 4 weeks. You would also need to use a continuous glucose monitor (CGM) for at least 4 weeks before screening and be willing to use it throughout the study.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"The primary outcome is measured at 1 year after the VX-880 infusion, suggesting follow-up for at least that long.\",\n}",243,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]