[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100461002":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":26,"locations":10,"responsibleParty":35,"collaborators":10,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":39,"sex":45,"minAge":10,"maxAge":10,"enrollmentInfo":46,"targetDuration":49,"studyType":50,"phases":10,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":65,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":10},{"fullName":5,"class":6},"NephroSant","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prospective Cohort with QSant Testing",null,"2,000 participants will be enrolled across sites within 90-days post-kidney transplant and followed for 24-months",[13],"Diagnostic Test: QSant-TM Urine Test",{"label":15,"type":10,"description":16,"interventionNames":10},"Retrospective Control Cohort without QSant Testing","2,000 site-matched controls from UNOS database who underwent a kidney transplant no more than 5 years prior to the study completion date",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DIAGNOSTIC_TEST","QSant-TM Urine Test","QSant™ is a needle free urine test collected in-home or in-clinic to aid in the evaluation and management of kidney transplant recipients' allograft status. QSant evaluates 6 kidney-specific biomarkers.",[9],[24,25],"QSant(TM)","QScore(TM)",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Director of Clinical Affairs","CONTACT","650-781-6337","registrysupport@nephrosant.com",{"name":33,"role":29,"phone":34,"phoneExt":10,"email":31},"VP of Product Management","833-697-7268",{"type":36,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100461002","assessment-of-qsant-for-underlying-allograft-rejection-100461002",false,"NCT05282966","Assessment of QSant™ for Underlying Allograft Rejection","Assessment of QSant™ for Underlying Allograft Rejection (AQUA Registry)","AQUA","Inclusion Criteria:\n\n1. Kidney transplant recipient, ≤ 90 days post kidney transplant of any age, solitary or combined multi-organ solid transplants which includes a kidney transplant.\n2. Able to understand risks and requirements of participation and provide informed consent\n3. Willing and able to comply with the study requirements\n\nExclusion Criteria:\n\n1. Inability to provide a voided urine sample per collection protocol\n2. Urological abnormalities such as augmented bladder, ileo-conduits, mitrofanoff, and vesicostomy.","ALL",{"count":47,"type":48},4000,"ESTIMATED","24 Months","OBSERVATIONAL","The AQUA registry is a multi-center observational study to assess the clinical management of kidney transplant recipients (KTRs) with use of the QSant test. QSant is a test based on 6 urinary biomarkers including cell-free DNA, that is used for the evaluation and management of acute rejection in renal allograft recipients with clinical suspicion of rejection, as well as subclinical rejection.",[53],"Kidney Transplant Failure and Rejection",[55,56,57,58,59,60,61,62,63,64],"kidney transplant","kidney biopsy","allograft rejection","subclinical allograft rejection","kidney","kidney health","kidney function","urine sample","urine test","kidney disease","NOT_YET_RECRUITING","2022-09-26",{"date":68,"type":69},"2022-09-28","ACTUAL",{"date":71,"type":48},"2023-03",{"date":73,"type":48},"2026-10",{"name":5,"class":6}]