Organ Transplantation Clinical Trial
— ACORG-HLAOfficial title:
Re-evaluation of Donor-specific Anti-HLA Alloantibodies Immunoassay After Organ Transplantation, From Antigen Level to Epitope Level: a Track to Improve Organ Allocation
NCT number | NCT03861962 |
Other study ID # | NI16035HLJ |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 2019 |
Est. completion date | May 2025 |
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.
Status | Not yet recruiting |
Enrollment | 20000 |
Est. completion date | May 2025 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of serum-specific donor antibodies (DSA) | Proportion of serum-specific donor antibodies (DSA) regarding epitope mismatches | at 2 years after organ transplantation | |
Secondary | Proportion of dnDSA anti-HLA | at 2 years after organ transplantation | ||
Secondary | Proportion of dnDSA anti-HLA | at 5 years after organ transplantation | ||
Secondary | Proportion of dnDSA anti-HLA | at 8 years after organ transplantation | ||
Secondary | Proportion of non-DSA anti-HLA antibodies | at 2 years after organ transplantation | ||
Secondary | Proportion of non-DSA anti-HLA antibodies | at 5 years after organ transplantation | ||
Secondary | Proportion of non-DSA anti-HLA antibodies | at 8 years after organ transplantation | ||
Secondary | 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 | at 2 years after organ transplantation | ||
Secondary | 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 | at 5 years after organ transplantation | ||
Secondary | 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 | at 8 years after organ transplantation | ||
Secondary | 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 | at 2 years after organ transplantation | ||
Secondary | 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 | at 5 years after organ transplantation | ||
Secondary | 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 | at 8 years after organ transplantation | ||
Secondary | 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 | at 2 years after organ transplantation | ||
Secondary | 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 | at 5 years after organ transplantation | ||
Secondary | 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 | at 8 years after organ transplantation | ||
Secondary | 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 | at 2 years after organ transplantation | ||
Secondary | 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 | at 5 years after organ transplantation | ||
Secondary | 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 | at 8 years after organ transplantation | ||
Secondary | Strength in mean fluorescence intensity of dnDSA anti-HLA de novo specific epitopes of epitopes DQbeta, DQalpha and composites (DQbeta + DQalpha) by antigen DQ | at 2 years after organ transplantation | ||
Secondary | Strength in mean fluorescence intensity of dnDSA anti-HLA de novo specific epitopes of epitopes DQbeta, DQalpha and composites (DQbeta + DQalpha) by antigen DQ | at 5 years after organ transplantation | ||
Secondary | Strength in mean fluorescence intensity of dnDSA anti-HLA de novo specific epitopes of epitopes DQbeta, DQalpha and composites (DQbeta + DQalpha) by antigen DQ | at 8 years after organ transplantation | ||
Secondary | Survival of the graft | at 5 years after organ transplantation | ||
Secondary | Survival of the graft | at 8 years after organ transplantation | ||
Secondary | Overall survival | at 5 years after organ transplantation | ||
Secondary | Overall survival | at 8 years after organ transplantation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT00987103 -
Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients
|
Phase 1 | |
Completed |
NCT03699839 -
Reducing the Burden of Influenza After Solid-Organ Transplantation
|
Phase 2/Phase 3 | |
Completed |
NCT01633424 -
The "Stanford Integrated Psychosocial Assessment for Transplant" (SIPAT)
|
||
Completed |
NCT01254955 -
Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients
|
N/A | |
Completed |
NCT00948883 -
Study of Cancers After Solid Organs Transplants
|
N/A | |
Recruiting |
NCT02314949 -
Leuven Tolerogenic Protocol for Intestinal Transplantation
|
N/A | |
Recruiting |
NCT01283295 -
Immune Monitoring and Assay Development in Organ Transplant Recipients
|
||
Completed |
NCT01123187 -
Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation
|
N/A | |
Completed |
NCT00213304 -
The Safety of Oka Varicella in Children Prior to Solid Organ Transplantation
|
Phase 3 | |
Completed |
NCT01515072 -
Remote Ischemic Preconditioning in Neurological Death Organ Donors
|
N/A | |
Completed |
NCT00904579 -
Cancer Risk in Organ Transplant Recipients and End-Stage Renal Disease
|
||
Recruiting |
NCT04687865 -
Constitution of a Biobank for Studies Related to Organ Transplantation (Lyon Centaure Biocollection)
|
||
Recruiting |
NCT00611494 -
Gastrointestinal Tolerability of MMF vs EC-MPS in Maintenance Transplant Patients Treated With Calcineurin Inhibitors
|
Phase 4 | |
Completed |
NCT02852902 -
Impact of Specific Antimicrobials and MIC Values on the Outcome of Bloodstream Infections Due to ESBL- or Carbapenemase-producing Enterobacterales in Solid Organ Transplantation: an Observational Multinational Study.
|
||
Completed |
NCT05685888 -
Effect of Ursodeoxycholic Acid on Preventing Covid-19 Infection in Patients With Organ Transplantation
|
||
Recruiting |
NCT00792064 -
Systematic Evaluation of Predictors of Quality of Life in the Long-term After Solid Organ Transplantation
|
N/A | |
Completed |
NCT00734396 -
Mesenchymal Stem Cells and Subclinical Rejection
|
Phase 1/Phase 2 | |
Completed |
NCT00286871 -
Randomized Controlled Trial in Liver Transplant Recipients Treated in Steroid Sparing Regimen
|
Phase 1 | |
Recruiting |
NCT03997253 -
Optimizing Long-term Survival in Organ Transplantation: From Physiopathology to Optimized Patient Management
|
N/A | |
Recruiting |
NCT01256931 -
Antibody Levels Against 2009 Influenza A H1N1 One Year After Vaccination With Pandemrix and 2010 Fluarix Booster in Organ Transplant Recipients.
|
N/A |