Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization
Pediatric Kidney Disease · Transplant;Failure,Kidney
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 1 years - 21 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 170 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the 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
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
monitoring by dd-cfDNA
Not reported in this registry record.
Procedure: monitoring by dd-cfDNA
monitoring by T-Vis
Not reported in this registry record.
Procedure: monitoring by T-Vis
monitoring by dd-cfDNA and T-Vis
Not reported in this registry record.
Procedure: monitoring by dd-cfDNA+ T-Vis
Current standard of care based on surveillance biopsies and biological monitoring
Not reported in this registry record.
monitoring by dd-cfDNA PROCEDURE
monitoring by dd-cfDNA
monitoring by T-Vis PROCEDURE
monitoring by T-Vis
monitoring by dd-cfDNA+ T-Vis PROCEDURE
monitoring by dd-cfDNA+ T-Vis
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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.
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.
Secondary measures
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.
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
Allograft fibrosis on the surveillance biopsy at 24 months
Time frame: 24 months
Not reported in this registry record.
Allograft function (estimated Glomerular Filtration Rate) at 24 months
Time frame: 24 months
Not reported in this registry record.
Predicted allograft survival until 10 years after evaluation
Time frame: 10 years
Not reported in this registry record.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Robert Debré HospitalParis, FranceRecruiting
Study team and timeline
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Study start
- Jan 22, 2026 Actual
- Primary completion
- Jan 22, 2028 Estimated
- Study completion
- Jan 22, 2029 Estimated
- First posted
- Jan 7, 2025 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026