Clinical trial NCT03916822: Cell-based Assays for Antibody-mediated Transplant Rejection
Official title: Validating Cell-based Assays for ABMR After Renal Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antibody-Mediated Graft Rejection
Keywords: Antibody mediated Rejection
Renal Transplantation
Adults
CD154
B-cells
B-cell subsets
alloantigen-specific
Lead sponsor: Plexision
Sponsor class: INDUSTRY
Collaborators: name: Medical University of South Carolina
First posted: 2019-04-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who have received primary renal transplants

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* IRB-approved informed consent.
* Adults (\>18 yr to 70 years)
* Primary renal transplant recipients with biopsy-proven ABMR, TCMR or recipients with no rejection

Exclusion Criteria:

* Lack of informed consent
* Concomitant BK virus infection
* Vulnerable populations including children \<18 yr, pregnant women, and prisoners

Primary outcomes:
measure: Antibody-mediated rejection
timeFrame: up to 90 days per subject
Secondary outcomes:
measure: T-cell mediated rejection (TCMR)
timeFrame: up to 90 days per subject
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Plexision
name: Rakesh Sindhi, MD
role: STUDY_DIRECTOR
References: