Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
NCT ID: NCT06761482
Last Updated: 2025-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
160 participants
INTERVENTIONAL
2025-03-01
2029-03-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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monitoring by dd-cfDNA
monitoring by dd-cfDNA
monitoring by dd-cfDNA
monitoring by T-Vis
monitoring by T-Vis
monitoring by T-Vis
monitoring by dd-cfDNA and T-Vis
monitoring by dd-cfDNA+ T-Vis
monitoring by dd-cfDNA+ T-Vis
Current standard of care based on surveillance biopsies and biological monitoring
No interventions assigned to this group
Interventions
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monitoring by dd-cfDNA
monitoring by dd-cfDNA
monitoring by T-Vis
monitoring by T-Vis
monitoring by dd-cfDNA+ T-Vis
monitoring by dd-cfDNA+ T-Vis
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
21 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Julien HOGAN, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Robert Debré Hospital
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IDRCB 2024-A01418-39
Identifier Type: REGISTRY
Identifier Source: secondary_id
APHP230817
Identifier Type: -
Identifier Source: org_study_id
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