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TTV-based mAnagement Of Long-term ImmunosuppreSsion in Kidney Transplantation

RecruitingNAAges 18 Years - anyAllHospices Civils de Lyon
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In plain words

What the trial is, and whether it could suit you

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. Torque 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. The TAOIST study tests whether longitudinal monitoring of TTV DNAemia e

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult ≥ 18 years-old * Recipient of a kidney allograft (third graft at most) * 12 to 48 months post-transplantation * Stable graft function (defined as: delta creatininemia over the previous 6 months \< 20% and proteinuria \< 30mg/mmol) * On maintenance immunosuppression, which includes CNI (cyclosporin or tacrolimus) and MMF (Cellcept or Myfortic) with or without corticosteroids * Detectable TTV DNAemia at enrollment * No circulating DSA in solid phase assay * Undetectable BKV DNAemia at enrollment * Written informed consent Exclusion Criteria: * Recipient of an HLA identical graft * Mutiple organ transplantation or functional transplant other than kidney * Maintenance immunosuppression that includes a mTOR inhibitor, belatacept or imurel * Presence of histological sign of active rejection (i+t \> 2 and g+cpt \> 2) on graft biopsy performed within 3 months before enrollment * Uncontrolled infection at inclusion * Infection requiring hospitalization within 3 months before inclusion * Diagnosis of a cancer of interest between the (current) transplantation and inclusion * Pregnant, unwillingness to practice adequate contraception or patient with a pregnancy plan during 3 years of study * Person not affiliated to a social security scheme or beneficiary of a similar scheme * Person subject to a legal protection measure (guardianship, curatorship) or deprived of liberty
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What it tests

  • TTV DNAemia
  • EQ-5D-5L questionnaire
  • Biological tests
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Where

4 sites
Service de Néphrologie-Transplantation-Dialyse I Hôpital Pellegrin I - CHU Bordeaux
Bordeaux (France), France
Service de transplantation, néphrologie et immunologie clinique Hospices Civils de Lyon, Hôpital Edouard Herriot
Lyon, France
Service de Néphrologie, Dialyse et Transplantation Rénale Nouvel Hôpital Civil
Strasbourg (france), France
Département de Néphrologie et Transplantation d'Organes Hôpital Rangueil - CHU de Toulouse
Toulouse (France), France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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