Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-21
SponsorAssistance Publique - Hôpitaux de Paris

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

Treatment groups

160 Participants
are divided into 4 treatment groups