[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579855":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":35,"locations":41,"responsibleParty":105,"collaborators":107,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":26,"enrollmentInfo":121,"targetDuration":26,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":133,"overallStatus":62,"whyStopped":26,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"Hospices Civils de Lyon","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"TTV-guided immunosuppression","EXPERIMENTAL","The adaptation of the dose of maintenance immunosuppressive drugs will be based on TTV DNAemia measured on site in the plasma of patients every 6 months (at distance of an infection or a vaccination). The physicians will be free to change the dose of calcineurin inhibitors (CNI) and\u002For the mycophenolate mofetil (MMF) to maintain TTV DNAemia between 3.8 and 5.1 log10 cp\u002FmL as long as the trough levels remain between 3-12 ng\u002FmL for tacrolimus (50-250 ng\u002FmL for cyclosporin) and the daily dose of MMF is comprise between 250 and 1500 mg bid for Cellcept (180 and 900 mg for Myfortic).",[13,14,15],"Biological: TTV DNAemia","Other: EQ-5D-5L questionnaire","Biological: Biological tests",{"label":17,"type":6,"description":18,"interventionNames":19},"Standard Immunosuppression","TTV DNAemia will also be measured every 6 months but the results will not be communicated to the physicians. Instead, the adaptation of the dose of maintenance immunosuppressive drugs will be performed according to the current standard of care: i) the dose of the CNI will be adapted to maintain the trough levels, monitored in the circulation every 3 month, between 5-10 ng\u002FmL for tacrolimus (75-150 ng\u002FmL for cyclosporin) and ii) the dose of MMF will be adjusted to maintain the AUC, measured every year, between 30-60 h.mg\u002FL.",[13,14,15],[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","TTV DNAemia","Every 6 months, one sample added at the same time (7mL) of a routine laboratory analysis for TTV DNAemia",[17,9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"EQ-5D-5L questionnaire","Completed every 6 months and each time a complication of interest occurs",[17,9],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Biological tests","Biological tests as routine care procedure (creatinine, CNI pre-dose trough level) will be performed every 6 months",[17,9],[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Olivier THAUNAT, Professor MD, PhD","CONTACT","+334.72.11.69.28","olivier.thaunat@chu-lyon.fr",[42,60,77,91],{"facility":43,"status":44,"city":45,"state":26,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Service de Néphrologie-Transplantation-Dialyse I Hôpital Pellegrin I - CHU Bordeaux","NOT_YET_RECRUITING","Bordeaux (France)","33000","France","FR",{"type":50,"coordinates":51},"Point",[52,53],-0.58046,44.84124,{"lat":53,"lon":52},[56],{"name":57,"role":38,"phone":58,"phoneExt":26,"email":59},"Lionel COUZI, MD, PhD","+335.56.79.55.38","lionel.couzi@chu-bordeaux.fr",{"facility":61,"status":62,"city":63,"state":26,"zip":64,"country":47,"countryCode":48,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Service de transplantation, néphrologie et immunologie clinique Hospices Civils de Lyon, Hôpital Edouard Herriot","RECRUITING","Lyon","69003",{"type":50,"coordinates":66},[67,68],4.84789,45.74906,{"lat":68,"lon":67},[71,75],{"name":72,"role":38,"phone":73,"phoneExt":74,"email":40},"Olivier THAUNAT, Professor","04.72.11.69.28","+33",{"name":72,"role":76,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"facility":78,"status":44,"city":79,"state":26,"zip":80,"country":47,"countryCode":48,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Service de Néphrologie, Dialyse et Transplantation Rénale Nouvel Hôpital Civil","Strasbourg (france)","67091",{"type":50,"coordinates":82},[83,84],7.74553,48.58392,{"lat":84,"lon":83},[87],{"name":88,"role":38,"phone":89,"phoneExt":26,"email":90},"Sophie CAILLARD OHLMANN, MD, PhD","+333.69.55.13.20","Sophie.OHLMANN@chru-strasbourg.fr",{"facility":92,"status":62,"city":93,"state":26,"zip":94,"country":47,"countryCode":48,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Département de Néphrologie et Transplantation d'Organes Hôpital Rangueil - CHU de Toulouse","Toulouse (France)","31059",{"type":50,"coordinates":96},[97,98],1.44367,43.60426,{"lat":98,"lon":97},[101],{"name":102,"role":38,"phone":103,"phoneExt":26,"email":104},"Nassim KAMAR, MD, PhD","+335.61.32.23.35","kamar.n@chu-toulouse.fr",{"type":106,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[108],{"name":109,"class":110},"BioMérieux","INDUSTRY","100579855","ttv-based-management-of-long-term-immunosuppression-in-kidney-transplantation-100579855",false,"NCT06829719","TTV-based mAnagement Of Long-term ImmunosuppreSsion in Kidney Transplantation","Personalization of Maintenance Immunosuppression Based on TTV Viral Load to Prevent Long-term Complications in Renal Transplantation","TAOIST","Inclusion Criteria:\n\n* Adult ≥ 18 years-old\n* Recipient of a kidney allograft (third graft at most)\n* 12 to 48 months post-transplantation\n* Stable graft function (defined as: delta creatininemia over the previous 6 months \\\u003C 20% and proteinuria \\\u003C 30mg\u002Fmmol)\n* On maintenance immunosuppression, which includes CNI (cyclosporin or tacrolimus) and MMF (Cellcept or Myfortic) with or without corticosteroids\n* Detectable TTV DNAemia at enrollment\n* No circulating DSA in solid phase assay\n* Undetectable BKV DNAemia at enrollment\n* Written informed consent\n\nExclusion Criteria:\n\n* Recipient of an HLA identical graft\n* Mutiple organ transplantation or functional transplant other than kidney\n* Maintenance immunosuppression that includes a mTOR inhibitor, belatacept or imurel\n* Presence of histological sign of active rejection (i+t \\> 2 and g+cpt \\> 2) on graft biopsy performed within 3 months before enrollment\n* Uncontrolled infection at inclusion\n* Infection requiring hospitalization within 3 months before inclusion\n* Diagnosis of a cancer of interest between the (current) transplantation and inclusion\n* Pregnant, unwillingness to practice adequate contraception or patient with a pregnancy plan during 3 years of study\n* Person not affiliated to a social security scheme or beneficiary of a similar scheme\n* Person subject to a legal protection measure (guardianship, curatorship) or deprived of liberty","ALL","18 Years",{"count":122,"type":123},600,"ESTIMATED","INTERVENTIONAL",[126],"NA","Long-term outcomes in kidney transplantation remain a significant challenge, as complications such as donor-specific antibodies (DSA), antibody-mediated rejection, infections, and cancer increasingly threaten graft and patient survival over time. The development of non-invasive biomarkers to guide the management of therapeutic immunosuppression beyond the first year post-transplantation is therefore a crucial unmet need.\n\nTorque Teno Virus (TTV), a non-pathogenic virus with a high prevalence worldwide, has emerged as a promising biomarker in this context. Its replication inversely reflects immune control by T cells, correlating with the depth of therapeutic immunosuppression. Additionally, its slow replication kinetics make TTV DNAemia a useful marker for evaluating patient adherence to immunosuppressive treatments.\n\nThe TAOIST study tests whether longitudinal monitoring of TTV DNAemia every six months, starting from the second year after transplantation, can guide the personalization of immunosuppressive therapy. The primary endpoint is the time to the first occurrence of complications linked to inadequate immunosuppression, including dnDSA, biopsy-proven rejection, infection, cancer, or graft loss. Secondary objectives include evaluating the acceptability of TTV DNAemia among healthcare professionals and assessing its cost-effectiveness compared to standard care. An ancillary objective examines the link between TTV DNAemia and the immunosuppressant possession ratio (IPR) to explore its potential as a marker of treatment adherence.",[129,130,131,132],"Infection","Cancer","Rejection","Kidney Transplantation",[134,135,136,137,138],"TTV","Biomarker","immunosuppression","precision medicine","kidney transplantation","2026-05-22",{"date":141,"type":142},"2026-05-27","ACTUAL",{"date":144,"type":142},"2025-04-23",{"date":146,"type":123},"2031-02-02",{"name":5,"class":6},4]