- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03861962
Re-evaluation of Donor-specific Anti-HLA Alloantibodies Immunoassay After Organ Transplantation, From Antigen Level to Epitope Level (ACORG-HLA)
Re-evaluation of Donor-specific Anti-HLA Alloantibodies Immunoassay After Organ Transplantation, From Antigen Level to Epitope Level: a Track to Improve Organ Allocation
Transplantation is the only treatment for end-stage organ dysfunction, with dialysis for the kidney. However, donor / recipient (D / R) tissue incompatibility accounts for the majority of long-term graft losses, through the development of serum-specific donor antibodies (DSA) to human leukocyte antigens (HLA) of donor, with a prevalence of about 10% at 2 years and 20% at 5 years.
DSA immunization is very often directed against one or a few of the donor's incompatible antigens, suggesting that epitopes (and antigens) are not all equally immunogenic. Identifying HLA epitopes that cause the most and the least immunization would help refine the graft distribution to better manage a limited resource by defining the D / R combinations to avoid or promote. Since the immunogenicity of an HLA epitope depends on the HLA of the recipient given the properties of the epitopes mentioned above, a very large cohort is needed to understand this question. To do so, it is necessary to redo these typings with a method exploring all the genes (add DQA1, DRB3 / 4/5, DPB1 and DPA1) when this has not been done after the graft as part of the standard care. This has become possible since 3 years by DNA sequencing called "new generation" (or NGS), a method that is supplanting all others for the medical care of patients in transplantation.
This study is a retrospective cohort study with 5-year follow-up. The investigators' main objective is to evaluate the predictive value of the number of mismatched HLA epitopes for the development of DSA anti-HLA de novo at 2 years. The investigators' secondary objectives are to evaluate this parameter at 5 and 8 years to determine which epitope mismatches should be favored / avoided in the future.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jean-Luc TAUPIN, Pr
- Número de teléfono: +331 42 49 90 81
- Correo electrónico: jean-luc.taupin@aphp.fr
Copia de seguridad de contactos de estudio
- Nombre: Sylvie Chevret, Pr
- Número de teléfono: +33142499742 +33142499742
- Correo electrónico: sylvie.chevret@paris7.jussieu.fr
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- patients (adults and children)
- patients recipients in France from 2008 to 2015 of a first kidney transplant / heart / lung / liver donor living or deceased, non-immunized anti-HLA before the transplant
- patients having preserved their graft > 2 years
- having agreed to the use for research purposes in transplantation of the remains of the DNA and serum samples taken as part of the care of which the remains are available
Exclusion Criteria:
- no inclusion if one of the inclusion criteria is not met
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Proportion of serum-specific donor antibodies (DSA)
Periodo de tiempo: at 2 years after organ transplantation
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Proportion of serum-specific donor antibodies (DSA) regarding epitope mismatches
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at 2 years after organ transplantation
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Proportion of dnDSA anti-HLA
Periodo de tiempo: at 2 years after organ transplantation
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at 2 years after organ transplantation
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Proportion of dnDSA anti-HLA
Periodo de tiempo: at 5 years after organ transplantation
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at 5 years after organ transplantation
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Proportion of dnDSA anti-HLA
Periodo de tiempo: at 8 years after organ transplantation
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at 8 years after organ transplantation
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Proportion of non-DSA anti-HLA antibodies
Periodo de tiempo: at 2 years after organ transplantation
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at 2 years after organ transplantation
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Proportion of non-DSA anti-HLA antibodies
Periodo de tiempo: at 5 years after organ transplantation
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at 5 years after organ transplantation
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Proportion of non-DSA anti-HLA antibodies
Periodo de tiempo: at 8 years after organ transplantation
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at 8 years after organ transplantation
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Proportion of both total and HLA class I or class II dnDSA by HLA locus (A, B, C, DRB1, DRB3 / 4/5, DQB1, DQA1, DPB1, DPA1) , by HLA antigen, by epitope, for all types of organs and by organ type
Periodo de tiempo: at 2 years after organ transplantation
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at 2 years after organ transplantation
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Proportion of both total and HLA class I or class II dnDSA by HLA locus (A, B, C, DRB1, DRB3 / 4/5, DQB1, DQA1, DPB1, DPA1) , by HLA antigen, by epitope, for all types of organs and by organ type
Periodo de tiempo: at 5 years after organ transplantation
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at 5 years after organ transplantation
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Proportion of both total and HLA class I or class II dnDSA by HLA locus (A, B, C, DRB1, DRB3 / 4/5, DQB1, DQA1, DPB1, DPA1) , by HLA antigen, by epitope, for all types of organs and by organ type
Periodo de tiempo: at 8 years after organ transplantation
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at 8 years after organ transplantation
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Number of dnDSA anti-HLA both total and by HLA class (class I versus class II), by HLA locus (A, B, C, DRB1, DRB3 / 4/5, DQB1, DQA1, DPB1, DPA1), by HLA antigen, for all organ types and organ type
Periodo de tiempo: at 2 years after organ transplantation
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at 2 years after organ transplantation
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Number of dnDSA anti-HLA both total and by HLA class (class I versus class II), by HLA locus (A, B, C, DRB1, DRB3 / 4/5, DQB1, DQA1, DPB1, DPA1), by HLA antigen, for all organ types and organ type
Periodo de tiempo: at 5 years after organ transplantation
|
at 5 years after organ transplantation
|
Number of dnDSA anti-HLA both total and by HLA class (class I versus class II), by HLA locus (A, B, C, DRB1, DRB3 / 4/5, DQB1, DQA1, DPB1, DPA1), by HLA antigen, for all organ types and organ type
Periodo de tiempo: at 8 years after organ transplantation
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at 8 years after organ transplantation
|
Distribution of anti-HLA dnDSA by targeted epitope and antigen (to define immunodominant and non-immunodominant epitopes and antigens), both total and by HLA class (class I versus class II), by HLA locus for all types of organs and organ type
Periodo de tiempo: at 2 years after organ transplantation
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at 2 years after organ transplantation
|
Distribution of anti-HLA dnDSA by targeted epitope and antigen (to define immunodominant and non-immunodominant epitopes and antigens), both total and by HLA class (class I versus class II), by HLA locus for all types of organs and organ type
Periodo de tiempo: at 5 years after organ transplantation
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at 5 years after organ transplantation
|
Distribution of anti-HLA dnDSA by targeted epitope and antigen (to define immunodominant and non-immunodominant epitopes and antigens), both total and by HLA class (class I versus class II), by HLA locus for all types of organs and organ type
Periodo de tiempo: at 8 years after organ transplantation
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at 8 years after organ transplantation
|
Distribution of strength anti-HLA dnDSA measured by mean fluorescence intensity to identify the immunodominant DSA, both global and by class, by HLA locus by HLA antigen, by epitope, for all types of organs and organ type
Periodo de tiempo: at 2 years after organ transplantation
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at 2 years after organ transplantation
|
Distribution of strength anti-HLA dnDSA measured by mean fluorescence intensity to identify the immunodominant DSA, both global and by class, by HLA locus by HLA antigen, by epitope, for all types of organs and organ type
Periodo de tiempo: at 5 years after organ transplantation
|
at 5 years after organ transplantation
|
Distribution of strength anti-HLA dnDSA measured by mean fluorescence intensity to identify the immunodominant DSA, both global and by class, by HLA locus by HLA antigen, by epitope, for all types of organs and organ type
Periodo de tiempo: at 8 years after organ transplantation
|
at 8 years after organ transplantation
|
Strength in mean fluorescence intensity of dnDSA anti-HLA de novo specific epitopes of epitopes DQbeta, DQalpha and composites (DQbeta + DQalpha) by antigen DQ
Periodo de tiempo: at 2 years after organ transplantation
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at 2 years after organ transplantation
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Strength in mean fluorescence intensity of dnDSA anti-HLA de novo specific epitopes of epitopes DQbeta, DQalpha and composites (DQbeta + DQalpha) by antigen DQ
Periodo de tiempo: at 5 years after organ transplantation
|
at 5 years after organ transplantation
|
Strength in mean fluorescence intensity of dnDSA anti-HLA de novo specific epitopes of epitopes DQbeta, DQalpha and composites (DQbeta + DQalpha) by antigen DQ
Periodo de tiempo: at 8 years after organ transplantation
|
at 8 years after organ transplantation
|
Survival of the graft
Periodo de tiempo: at 5 years after organ transplantation
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at 5 years after organ transplantation
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Survival of the graft
Periodo de tiempo: at 8 years after organ transplantation
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at 8 years after organ transplantation
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Overall survival
Periodo de tiempo: at 5 years after organ transplantation
|
at 5 years after organ transplantation
|
Overall survival
Periodo de tiempo: at 8 years after organ transplantation
|
at 8 years after organ transplantation
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- NI16035HLJ
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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