Antibody-Mediated Graft Rejection Clinical Trial
Official title:
Validating Cell-based Assays for ABMR After Renal Transplantation
Goal: The goal of this study is to validate blood tests, which can detect antibody-mediated rejection (ABMR) after renal transplantation. These cell based assays measure CD154-expressing alloantigen-specific B-cells and their subsets in peripheral blood of adult renal transplant recipients. Thirty recipients will be enrolled at two transplant centers, 10 each with ABMR, T-cell mediated rejection (TCMR), and no rejection. Each subject will be sample twice, before and after rejection. Donor-specific anti-HLA antibodies will also be measured with single antigen beads.
This cross-sectional open label study will evaluate whether alloantigen-specific B-cells and
their subsets which express CD154 are associated with antibody-mediated rejection after first
time renal transplantation in adult recipients.
Control groups include adult renal transplant recipients with T-cell-mediated rejection, and
without rejection of any type.
Alloantigen-specific B-cells will be measured after stimulation of recipient peripheral blood
leukocytes with those from corresponding donor and HLA-non-identical reference cells.
Thirty total subjects will be enrolled after IRB-approved informed consent, 15 at each of two
sites. These subjects will include ten each with biopsy-proven ABMR and TCMR and ten with no
rejection.
Each subject will be sampled twice, before and after treatment rejection, at intervals no
less than 30 days, and not to exceed 90 days.
B-cells subsets will include those that also express cytokines, and those that are
categorized as memory or naive, and their isotope switched or unswitched subsets,
transitional B-cells or plasmablasts, etc.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03393793 -
HEart trAnsplantation Registry of piTie-Salpetriere University Hospital
|