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

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Pediatric Kidney Disease; Transplant;Failure,Kidney

Treatments: Procedure: monitoring by T-Vis; Procedure: monitoring by dd-cfDNA; Procedure: monitoring by dd-cfDNA+ T-Vis

Study type: Interventional

Funder types: Other

Identifiers

NCT06761482

APHP230817

IDRCB 2024-A01418-39 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 160 estimated patients

Sex: All

Ages: 1 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

monitoring by dd-cfDNA

Experimental group

Treatment:

Procedure: monitoring by dd-cfDNA

monitoring by T-Vis

Experimental group

Treatment:

Procedure: monitoring by T-Vis

monitoring by dd-cfDNA and T-Vis

Experimental group

Treatment:

Procedure: monitoring by dd-cfDNA+ T-Vis

Current standard of care based on surveillance biopsies and biological monitoring

No Intervention group