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Not yet recruiting NCT06761482

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

No phase Interventional Pediatric Kidney Disease Transplant;Failure,Kidney

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: monitoring by dd-cfDNA, monitoring by T-Vis, monitoring by dd-cfDNA+ T-Vis.
Who it may be relevant to
Registry conditions: Pediatric Kidney Disease, Transplant;Failure,Kidney. Basic parameters: 1 year — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

Interventions

  • 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

Primary outcome measures

  • Number of kidney allograft during the 2 years post-transplantation [Time frame: 24 months]
  • Exposure to calcineurin inhibitors (mean tacrolimus level) between month 6 and month 24 post-transplantation. [Time frame: 24 months]
Secondary outcome measures (5)
  • Number of participants with adverse events as assessed by CTCAE v4.0 in each group [Time frame: 24 months]
  • Cost-utility [Time frame: 24 months]
  • Allograft fibrosis on the surveillance biopsy at 24 months [Time frame: 24 months]
  • Allograft function (estimated Glomerular Filtration Rate) at 24 months [Time frame: 24 months]
  • Predicted allograft survival until 10 years after evaluation [Time frame: 10 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Robert Debré Hospital — Paris

Identifiers

NCT: NCT06761482 · APHP230817 · IDRCB 2024-A01418-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗