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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB 2024-A01418-39 | Registry Identifier | ANSM |
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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.
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 :
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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| monitoring by dd-cfDNA | Experimental |
| |
| monitoring by T-Vis | Experimental |
| |
| monitoring by dd-cfDNA and T-Vis | Experimental |
| |
| Current standard of care based on surveillance biopsies and biological monitoring | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| monitoring by dd-cfDNA | Procedure | monitoring by dd-cfDNA |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of kidney allograft during the 2 years post-transplantation | 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. | To demonstrate that steering immunosuppression based on Tvis numbers allows the reduction of the exposition to calcineurin inhibitors. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as assessed by CTCAE v4.0 in each group | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julien HOGAN, MD, PhD | Contact | +331 40 03 21 42 | julien.hogan@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Julien HOGAN, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Debré Hospital | Paris | 75019 | France |
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An open label multicenter prospective randomized trial of superiority with two active comparators / 4 groupes : monitoring by dd-cfDNA; monitoring by T-Vis; monitoring by dd-cfDNA+ T-Vis; Current standard of care based on surveillance biopsies and biological monitoring
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| monitoring by T-Vis |
| Procedure |
monitoring by T-Vis |
|
| monitoring by dd-cfDNA+ T-Vis | Procedure | monitoring by dd-cfDNA+ T-Vis |
|
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 | 24 months |
| Allograft function (estimated Glomerular Filtration Rate) at 24 months | 24 months |
| Predicted allograft survival until 10 years after evaluation | 10 years |
| ID | Term |
|---|---|
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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