An observational study in Kidney Transplant Rejection, sponsored by University Hospital, Grenoble. Not yet recruiting. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by University Hospital, Grenoble · Observational
Kidney transplantation is the best treatment for chronic renal failure in terms of morbidity and mortality, quality of life for patients and health economics. Sensitization with anti-Human Leukocyte Antigen antibodies is a barrier to access to transplantation.
Highly-sensitized patients wait 2 to 3 times longer on the waiting list with important health and economic consequences. Desensitization strategies by apheresis techniques allow access to a transplant with a negative crossmatch (absence of specific HLA antibodies against their donor) on the day of the transplant.
The main objective of this study is to assess the impact of desensitization on the antibody memory immune response in highly sensitized patients awaiting kidney transplantation.
The analyses will be based on samples from the 20 patients (10 desensitized transplanted patients, 5 highly sensitized non-desensitized transplanted patients and 5 healthy donors) at the University Hospital of Grenoble, France.
Analyses will include phenotypic and immuno-metabolic analysis by flow cytometry of antibody-secreting cells, a functional analysis by anti HLA ELISpot B technique and histological analysis of post-kidney transplantation follow-up renal biopsies with gene expression mapping (RNA tissue labeling using the Nanostring technique) within the renal parenchyma.
University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
15 highly sensitized patients: 10 that received desensitization before kidney transplan tation and 5 that were not desensitized before kidney transplantation.
5 healthy donors
contraception associated with ovulation inhibition :
Progestin-only hormonal contraception associated with ovulation inhibition:
Exclusion Criteria:
Patient that were HLA desensitized for kidney transplantation
Procedure: Desensitization
Patient that were not HLA desensitized for kidney transplantation but were highly sensitized and received a kidney graft due to local priority system
Patients that received apheresis and anti-cluster of differentiation antigen 20 for desensitization priori to kidney transplantation
Change in Flow Cytometry analyses of Peripheral Blood Mononuclear Cells
Change of the percentage of "antibody secreting cells" (plasmablasts) over time
Time frame: Before desensitization, at the time of transplantation and Before desensitization, at the time of transplantation and post transplantation
Change in Anti HLA B-cell ELISpot response
Change in the number of Spot over time
Time frame: Before desensitization, at the time of transplantation and Month 3, Month 6 and Month 12 post transplantation
Change in Flow Cytometry analyses of medullary cells
Change in the percentage of "antibody secreting cells" (plasmablasts) over time
Time frame: The first day of desensitization and at the day of kidney transplantation
Change in analyses of RNA expression on renal histology
CHange in percentage of gene expression using Nanostring technology
Time frame: Month1, Month 3 and Month 12 post transplantation
No study locations are listed for this record.
This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble