[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574607":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":34,"centralContacts":38,"locations":43,"responsibleParty":59,"collaborators":11,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":11,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":86,"whyStopped":11,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"monitoring by dd-cfDNA","EXPERIMENTAL",null,[13],"Procedure: monitoring by dd-cfDNA",{"label":15,"type":10,"description":11,"interventionNames":16},"monitoring by T-Vis",[17],"Procedure: monitoring by T-Vis",{"label":19,"type":10,"description":11,"interventionNames":20},"monitoring by dd-cfDNA and T-Vis",[21],"Procedure: monitoring by dd-cfDNA+ T-Vis",{"label":23,"type":24,"description":11,"interventionNames":11},"Current standard of care based on surveillance biopsies and biological monitoring","NO_INTERVENTION",[26,29,31],{"type":27,"name":9,"description":9,"armGroupLabels":28,"otherNames":11},"PROCEDURE",[9],{"type":27,"name":15,"description":15,"armGroupLabels":30,"otherNames":11},[15],{"type":27,"name":32,"description":32,"armGroupLabels":33,"otherNames":11},"monitoring by dd-cfDNA+ T-Vis",[19],[35],{"name":36,"affiliation":5,"role":37},"Julien HOGAN, MD, PhD","PRINCIPAL_INVESTIGATOR",[39],{"name":36,"role":40,"phone":41,"phoneExt":11,"email":42},"CONTACT","+331 40 03 21 42","julien.hogan@aphp.fr",[44],{"facility":45,"status":11,"city":46,"state":11,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Robert Debré Hospital","Paris","75019","France","FR",{"type":51,"coordinates":52},"Point",[53,54],2.3488,48.85341,{"lat":54,"lon":53},[57],{"name":36,"role":40,"phone":41,"phoneExt":11,"email":58},"julein.hogan@aphp.fr",{"type":60,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100574607","non-invasive-monitoring-of-pediatric-kidney-transplant-recipients-and-immunosuppression-personalization-an-open-labeled-multicenter-randomized-controlled-study-100574607",false,"NCT06761482","Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study","MONITOR","Inclusion Criteria:\n\n* Age less than 21 years old at transplantation\n* Single renal transplant from a deceased or a living donor.\n* Absence of pregnancy confirmed by a negative pregnancy test in women in child-bearing period.\n* Subject and legal guardians are willing and able to provide signed written informed consent and to comply with the study procedures\n* Patients affiliated to health insurance system including Aide Médicale de l'Etat (AME)\n\nExclusion Criteria:\n\n* History of multi-organ transplant (interference with rejection natural history)\n* No surveillance biopsy planned\n* Adult patient (or legal guardians) with limited understanding of the French language preventing him from receiving informed information on the protocol","ALL","1 Year","21 Years",{"count":72,"type":73},160,"ESTIMATED","INTERVENTIONAL",[76],"NA","Currently, the monitoring of children receiving a kidney transplantation includes surveillance biopsies to detect subclinical rejection and signs of toxicity of immunosuppressive drugs (tacrolimus).\n\nThe hypothesis of the study is that the combination of non-invasive biomarkers (Donor-derived cell-free DNA and Virus-specific T cells) will allow both the safe discontinuation of surveillance biopsies and the personalization of the exposure to calcineurin inhibitors among pediatric kidney transplant recipients.",[79,80],"Pediatric Kidney Disease","Transplant;Failure,Kidney",[82,83,84,85],"kidney","transplant","pediatric","rejection","NOT_YET_RECRUITING","2024-12-30",{"date":89,"type":90},"2025-01-07","ACTUAL",{"date":92,"type":73},"2025-03-01",{"date":94,"type":73},"2029-03-01",{"name":5,"class":6},1]