NCT06829719 TTV-based mAnagement Of Long-term ImmunosuppreSsion in Kidney Transplantation

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This trial targets 600 participants in total. It began in 2025-04-23 with a primary completion date of 2028-05-01.

Brief Summary

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 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.

Eligibility Criteria

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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