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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Dec 30, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at new ways to monitor children who have received a kidney transplant, aiming to reduce the need for painful kidney biopsies. Right now, doctors often perform these biopsies to check for signs that the body might be rejecting the new kidney or that the medications to prevent rejection are causing harm. The study is testing whether certain non-invasive tests, like measuring DNA from the donor kidney in the child's blood and checking for specific immune cells, can help doctors safely personalize medication dosages and avoid unnecessary biopsies.

To join this study, children must be under 21 years old, have received a single kidney transplant from either a deceased or living donor, and have a negative pregnancy test if they are female. Participants and their guardians need to understand the study and agree to take part. The trial is currently not recruiting participants, but once it starts, those involved can expect to provide blood samples for testing instead of undergoing regular biopsies, which could make their experience more comfortable.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • Patients affiliated to health insurance system including Aide Médicale de l'Etat (AME)
• Exclusion Criteria:
• • 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