Ikke-invasiv overvågning af pædiatriske nyretransplantationsmodtagere og immunsuppression personalisering: et åbent mærket multicenter randomiseret kontrolleret undersøgelse (MONITOR)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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 :
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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
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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
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Julien HOGAN, MD, PhD
- Telefonnummer: +331 40 03 21 42
- E-mail: julien.hogan@aphp.fr
Studiesteder
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-
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Paris, Frankrig, 75019
- Rekruttering
- Robert Debré Hospital
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Kontakt:
- Julien HOGAN, MD, PhD
- Telefonnummer: +331 40 03 21 42
- E-mail: julein.hogan@aphp.fr
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: overvågning med dd-cfDNA
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monitoring by dd-cfDNA |
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Eksperimentel: overvågning af T-Vis
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monitoring by T-Vis |
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Eksperimentel: overvågning med dd-cfDNA og T-Vis
|
monitoring by dd-cfDNA+ T-Vis |
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Ingen indgriben: Nuværende standard for pleje baseret på overvågningsbiopsier og biologisk overvågning
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of kidney allograft during the 2 years post-transplantation
Tidsramme: 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
|
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Exposure to calcineurin inhibitors (mean tacrolimus level) between month 6 and month 24 post-transplantation.
Tidsramme: 24 months
|
To demonstrate that steering immunosuppression based on Tvis numbers allows the reduction of the exposition to calcineurin inhibitors. |
24 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Allograft fibrose på overvågningsbiopsien ved 24 måneder
Tidsramme: 24 måneder
|
24 måneder
|
|
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Allograftfunktion (estimeret glomerulær filtrationshastighed) efter 24 måneder
Tidsramme: 24 måneder
|
24 måneder
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Forudsagt allotransplantat-overlevelse indtil 10 år efter evaluering
Tidsramme: 10 år
|
10 år
|
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Number of participants with adverse events as assessed by CTCAE v4.0 in each group
Tidsramme: 24 months
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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
|
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Cost-utility
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Julien HOGAN, MD, PhD, Assistance Publique - Hôpitaux de Paris
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- APHP230817
- IDRCB 2024-A01418-39 (Registry Identifier: ANSM)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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