About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- monitoring by dd-cfDNA
- monitoring by T-Vis
- monitoring by dd-cfDNA+ T-Vis