[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657205":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":40,"studyPopulation":11,"armGroups":41,"interventions":54,"overallOfficials":11,"centralContacts":64,"locations":11,"responsibleParty":70,"collaborators":11,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":11,"enrollmentInfo":82,"targetDuration":11,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":102,"whyStopped":11,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":11},{"fullName":5,"class":6},"Eledon Pharmaceuticals","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Efficacy failure rate at 12 months post-transplant, defined as the first occurrence of biopsy proven acute rejection, graft loss, or death",null,"12 months post-transplant",[14,16,18,21,23,25,27,29,31],{"measure":15,"description":11,"timeFrame":12},"Proportion of participants with for-cause biopsy proven acute rejection, graft loss, or death",{"measure":17,"description":11,"timeFrame":12},"Participant and graft survival",{"measure":19,"description":20,"timeFrame":12},"iBox score at 12 months post-transplant survival","iBox is the validated tool for predicting the risk of kidney transplant loss based on artificial intelligence. Range of score is 0%-100%, higher score indicates better kidney survival.",{"measure":22,"description":11,"timeFrame":12},"Mean Renal graft function as assessed by estimated glomerular filtration rate",{"measure":24,"description":11,"timeFrame":12},"Incidence of new-onset diabetes after transplantation",{"measure":26,"description":11,"timeFrame":12},"Incidence of new or worsening hypertension",{"measure":28,"description":11,"timeFrame":12},"Incidence of new or worsening hyperlipidemia",{"measure":30,"description":11,"timeFrame":12},"Proportion of participants experiencing deterioration on Patient Reported Outcomes",{"measure":32,"description":11,"timeFrame":33},"Incidence of delayed graft function","Initial post-transplant period",{"allocation":35,"interventionModel":36,"interventionModelDescription":11,"primaryPurpose":37,"observationalModel":11,"timePerspective":11,"maskingInfo":38},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":39,"maskingDescription":11,"whoMasked":11},"NONE","This is a multicenter, randomized, active-controlled, open-label study to assess the efficacy and safety of tegoprubart compared with tacrolimus as part of an immunosuppressive regimen in adult participants undergoing first kidney transplantation. Dose regimens will include either tegoprubart (AT-1501) or tacrolimus.",[42,48],{"label":43,"type":44,"description":45,"interventionNames":46},"Investigative Arm","EXPERIMENTAL","Tegoprubart",[47],"Drug: Tegoprubart",{"label":49,"type":50,"description":51,"interventionNames":52},"Comparator Arm","ACTIVE_COMPARATOR","Tacrolimus",[53],"Drug: Tacrolimus",[55,61],{"type":56,"name":45,"description":57,"armGroupLabels":58,"otherNames":59},"DRUG","Tegoprubart administered via IV infusion",[43],[60],"AT-1501",{"type":56,"name":51,"description":62,"armGroupLabels":63,"otherNames":11},"Tacrolimus administered orally",[49],[65],{"name":66,"role":67,"phone":68,"phoneExt":11,"email":69},"Eledon Main Contact","CONTACT","949-238-8090","clinicaltrials@eledon.com",{"type":71,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100657205","phase-3-phase-3-randomized-study-of-tegoprubart-efficacy-and-safety-compared-with-tacrolimus-in-kidney-transplantation-100657205",false,"NCT07835581","Study of Tegoprubart Efficacy and Safety Compared With Tacrolimus in Kidney Transplantation","A Multicenter, Phase 3 Randomized, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Tegoprubart Compared With Tacrolimus in Adult Participants Undergoing De Novo Kidney Transplantation","LEGACY","Inclusion Criteria:\n\n* Undergoing kidney transplant with a living or deceased donor kidney\n* Adult participants that have reached the age of consent and are ≥18 years of age\n* Written informed consent prior to any study assessment\n\nExclusion Criteria:\n\n* Conditions or circumstances that, in the investigator's judgment or according to protocol-defined criteria, would make participation unsafe, interfere with study assessments, or compromise protocol compliance.","ALL","18 Years",{"count":83,"type":84},620,"ESTIMATED","INTERVENTIONAL",[87],"PHASE3","This study will evaluate the efficacy and safety of tegoprubart compared with tacrolimus in adult participants undergoing first kidney transplantation.",[90],"Kidney Transplant Rejection",[60,92,93,94,95,96,97,98,99,100,101],"Kidney Transplant","Renal Allograft Rejection","Prophylaxis","CD40L Inhibitor","Humanized blocking antibody to CD40L","monoclonal antibody","renal","transplant","ESRD","tegoprubart","NOT_YET_RECRUITING","2026-09-25",{"date":105,"type":106},"2026-09-30","ACTUAL",{"date":108,"type":84},"2026-10",{"date":110,"type":84},"2033-03",{"name":5,"class":6}]