NCT06761482

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

MONITOR is an open label multicenter prospective randomized trial of superiority with two active comparators (4 parallel groups 1:1:1:1). Arm A: monitoring by dd-cfDNA; Arm B: monitoring by T-Vis; Arm C: monitoring by dd-cfDNA+ T-Vis; Comparator arm: Current standard of care based on surveillance biopsies and biological monitoring Main objectives and primary endpoints : 1. 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. Endpoint: Number of biopsy performed in each arm 2. To demonstrate that steering immunosuppression based on Tvis numbers allows the reduction of the exposition to calcineurin inhibitors. Endpoint: Tacrolimus exposure assessed as the mean of the residual concentration of Tacrolimus between M6 and M24

Conditions

• Pediatric Kidney Disease
• Transplant;Failure,Kidney

Interventions

Type	Name	Description
PROCEDURE	monitoring by dd-cfDNA	monitoring by dd-cfDNA
PROCEDURE	monitoring by T-Vis	monitoring by T-Vis
PROCEDURE	monitoring by dd-cfDNA+ T-Vis	monitoring by dd-cfDNA+ T-Vis

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-03-01
• Completion: 2029-03-01
• First posted: 2025-01-07
• Last updated: 2025-01-07

Locations

1 site across 1 country: France