[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06336863":3,"trial-entities:NCT06336863":103,"trial-summary:NCT06336863":107},{"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":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":45,"secondary_outcomes":54,"sex":70,"minimum_age":71,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":72,"std_ages":84,"locations":87,"central_contacts":96,"overall_officials":97,"references":101,"see_also_links":102},"NCT06336863","STU-2023-1151","Use of DNA Testing and Gene Expression Profiling to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression","An Extension Protocol for Subjects Previously Enrolled in the \"Use of Donor Derived-cell Free DNA (AlloSure) and Gene Expression Profiling (AlloMap Kidney) to Facilitate Belatacept Monotherapy in Kidney Transplant Patients\"","ENROLLING_BY_INVITATION","2026-12","2025-07","2025-07-14","2024-06-14","University of Texas Southwestern Medical Center","OTHER",false,"The purpose of the study is to provide immunosuppression weaning and\u002For monitoring for an additional 12-months to evaluate the safety and efficacy of belatacept monotherapy in patients previously enrolled in the clinical trial: \"Use of donor derived-cell free DNA (AlloSure) and gene expression profiling (AlloMap Kidney) to facilitate Belatacept monotherapy in kidney transplant patients.\"",null,[19],"Kidney Transplant Immunosuppression",[21,22,23,24,25,26],"Belatacept Monotherapy","Kidney Transplant Recipients","Immunosuppression","Weaning","DNA Testing","Gene Expression","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},24,"ESTIMATED",[35,42],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DIAGNOSTIC_TEST","Allosure and TruGraf","Precision medicine will be employed to withdraw immunosuppression in kidney transplant recipients.",[40,41],"Immunosuppression Taper","Multi-Drug Regimen",{"type":14,"name":40,"description":43,"armGroupLabels":44},"An immunosuppression taper will be employed over a 12-month period for those that are deemed immune quiescent.",[40],[46,50],{"measure":47,"description":48,"timeFrame":49},"Incidence of acute kidney graft rejection","Number of patients with biopsy-proven acute kidney graft rejection","12 months after informed consent",{"measure":51,"description":52,"timeFrame":53},"Incidence of facilitation to Belatacept monotherapy","Percentage of subjects successfully weaned to a Belatacept monotherapy","12 months after the first study visit",[55,58,61,64,67],{"measure":56,"description":57,"timeFrame":49},"Patient Survival after Immunosuppression Wean","Number of patients who died",{"measure":59,"description":60,"timeFrame":49},"Kidney Graft Failure after Immunosuppression Wean","Number of patients with kidney graft failure. Graft failure is defined as date of patient death or date of re-transplant",{"measure":62,"description":63,"timeFrame":49},"Mean change in Estimated Glomerular Filtration Rate (eGFR) after Immunosuppression Wean","Estimated glomerular filtration rate (eGFR) in blood will be measured at the beginning of enrollment and the difference will be measured to the end of the study as a measure of change in kidney function.",{"measure":65,"description":66,"timeFrame":49},"Incidence of Proteinuria after Immunosuppression Wean","Proteinuria will be detected by a semiquantitative method of the protein concentration in urine.",{"measure":68,"description":69,"timeFrame":49},"Incidence of de-novo donor specific antibodies (dnDSA)","HLA type I and type II in blood will be used to detect the presence of de-novo donor specific antibodies (dnDSA) in those who have started the immunosuppression wean.","ALL","18 Years",{"inclusion":73,"exclusion":78,"raw_text":83},[74,75,76,77],"Completion of the parent study (STU-2020-1339)","Able to provide informed consent","Absence of donor specific antibodies","Stable renal function (eGFR\\>40mL\u002Fmin for 3 months prior to enrollment)",[79,80,81,82],"Female participant who is pregnant, lactating or planning pregnancy during the course of the trial","Significant hepatic impairment","Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial","Proteinuria \\> 0.5 g\u002Fg creatinine on spot urine sample within 3 months of enrollment","Inclusion Criteria:\n\n* Completion of the parent study (STU-2020-1339)\n* Able to provide informed consent\n* Absence of donor specific antibodies\n* Stable renal function (eGFR\\>40mL\u002Fmin for 3 months prior to enrollment)\n\nExclusion Criteria:\n\n* Female participant who is pregnant, lactating or planning pregnancy during the course of the trial\n* Significant hepatic impairment\n* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial\n* Proteinuria \\> 0.5 g\u002Fg creatinine on spot urine sample within 3 months of enrollment",[85,86],"ADULT","OLDER_ADULT",[88],{"facility":13,"city":89,"state":90,"zip":91,"country":92,"geoPoint":93},"Dallas","Texas","75390","United States",{"lat":94,"lon":95},32.78306,-96.80667,[],[98],{"name":99,"affiliation":13,"role":100},"David Wojciechowski, DO","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":104,"biomarkers":106},[105],"Kidney Transplantation",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]