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

Not Applicable

Not yet recruiting

• Conditions: Pediatric Kidney Disease; Transplant;Failure,Kidney

• Registration Number: NCT06761482
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-30
• Last Update Submitted: 2024-12-30
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Study Start: 2025-03-01
• Primary Completion: 2027-03-01
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events as assessed by CTCAE v4.0 in each group	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.
Cost-utility	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
Allograft fibrosis on the surveillance biopsy at 24 months	24 months
Allograft function (estimated Glomerular Filtration Rate) at 24 months	24 months
Predicted allograft survival until 10 years after evaluation	10 years

Trial Locations

Locations (1)

Robert Debré Hospital; 🇫🇷 Paris, France