Currently, the monitoring of children receiving a kidney transplantation includes surveillance biopsies to detect subclinical rejection and signs of toxicity of immunosuppressive drugs (tacrolimus).
The 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.
Age less than 21 years old at transplantation
Single renal transplant from a deceased or a living donor.
Absence of pregnancy confirmed by a negative pregnancy test in women in child-bearing period.
Subject and legal guardians are willing and able to provide signed written informed consent and to comply with the study procedures
History of multi-organ transplant (interference with rejection natural history)
No surveillance biopsy planned
Adult patient (or legal guardians) with limited understanding of the French language preventing him from receiving informed information on the protocol
Parallel
monitoring by dd-cfDNA
Procedure/Surgerymonitoring by dd-cfDNA
monitoring by T-Vis
Procedure/Surgerymonitoring by T-Vis
monitoring by dd-cfDNA+ T-Vis
Procedure/Surgerymonitoring by dd-cfDNA+ T-Vis
Number of kidney allograft during the 2 years post-transplantation
To demonstrate that the use of an integrative score of allograft rejection including dd-cfDNA measurement allows the reduction of the number of surveillance biopsies.
Exposure to calcineurin inhibitors (mean tacrolimus level) between month 6 and month 24 post-transplantation.
To demonstrate that steering immunosuppression based on Tvis numbers allows the reduction of the exposition to calcineurin inhibitors.
Number of participants with adverse events as assessed by CTCAE v4.0 in each group
Adverse events of particular interest will include de novo donor specific antibodies (DSA) formation, clinical rejection, plasma viral replication Cytomegalovirus Virus, Epstein-Barr virus, BK virus.
Cost-utility
Data sources for the latter will include the trial's case report form data for efficacy and resource consumption in terms of ambulatory care, informal care, and productivity losses. It will be complemented by participating hospitals' discharge data to gather information relative to hospital care and its associated costs. The effectiveness criteria will be the number of quality-adjusted life-years (QALYs) gained. QALYs will be derived from patients' responses to the EQ-5D questionnaire
Allograft fibrosis on the surveillance biopsy at 24 months
Allograft function (estimated Glomerular Filtration Rate) at 24 months
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