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

December 30, 2024 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75019
        • Robert Debre Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: monitoring by dd-cfDNA
Procedure: monitoring by dd-cfDNA
monitoring by dd-cfDNA
Experimental: monitoring by T-Vis
Procedure: monitoring by T-Vis
monitoring by T-Vis
Experimental: monitoring by dd-cfDNA and T-Vis
Procedure: monitoring by dd-cfDNA+ T-Vis
monitoring by dd-cfDNA+ T-Vis
No Intervention: Current standard of care based on surveillance biopsies and biological monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of kidney allograft during the 2 years post-transplantation
Time Frame: 24 months
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.
24 months
Exposure to calcineurin inhibitors (mean tacrolimus level) between month 6 and month 24 post-transplantation.
Time Frame: 24 months
To demonstrate that steering immunosuppression based on Tvis numbers allows the reduction of the exposition to calcineurin inhibitors.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events as assessed by CTCAE v4.0 in each group
Time Frame: 24 months
Adverse events of particular interest will include de novo donor specific antibodies (DSA) formation, clinical rejection, plasma viral replication Cytomegalovirus Virus, Epstein-Barr virus, BK virus.
24 months
Cost-utility
Time Frame: 24 months
Data sources for the latter will include the trial's case report form data for efficacy and resource consumption in terms of ambulatory care, informal care, and productivity losses. It will be complemented by participating hospitals' discharge data to gather information relative to hospital care and its associated costs. The effectiveness criteria will be the number of quality-adjusted life-years (QALYs) gained. QALYs will be derived from patients' responses to the EQ-5D questionnaire
24 months
Allograft fibrosis on the surveillance biopsy at 24 months
Time Frame: 24 months
24 months
Allograft function (estimated Glomerular Filtration Rate) at 24 months
Time Frame: 24 months
24 months
Predicted allograft survival until 10 years after evaluation
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Julien HOGAN, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

December 30, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 30, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP230817
  • IDRCB 2024-A01418-39 (Registry Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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