Cell-based Assays for Antibody-mediated Transplant Rejection
NCT ID: NCT03916822
Last Updated: 2020-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2019-04-15
2021-08-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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ABMR
Biopsy-proven ABMR-Banff criteria, with or without Complement binding donor-specific anti-HLA antibodies
Alloantigen-specific B-cells
Alloantigen-specific B-cells which express CD154 and their subsets which also co-express cytokines, memory and naive markers, and additional derivatives of these markers will be measured with flow cytometry
TCMR
Biopsy-proven TCMR-Banff 1A, 1B, 2 and 3
Alloantigen-specific B-cells
Alloantigen-specific B-cells which express CD154 and their subsets which also co-express cytokines, memory and naive markers, and additional derivatives of these markers will be measured with flow cytometry
No Rejection
Biopsy-proven, or clinical criteria
Alloantigen-specific B-cells
Alloantigen-specific B-cells which express CD154 and their subsets which also co-express cytokines, memory and naive markers, and additional derivatives of these markers will be measured with flow cytometry
Interventions
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Alloantigen-specific B-cells
Alloantigen-specific B-cells which express CD154 and their subsets which also co-express cytokines, memory and naive markers, and additional derivatives of these markers will be measured with flow cytometry
Eligibility Criteria
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Inclusion Criteria
* Adults (\>18 yr to 70 years)
* Primary renal transplant recipients with biopsy-proven ABMR, TCMR or recipients with no rejection
Exclusion Criteria
* Concomitant BK virus infection
* Vulnerable populations including children \<18 yr, pregnant women, and prisoners
18 Years
70 Years
ALL
No
Sponsors
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Medical University of South Carolina
OTHER
Plexision
INDUSTRY
Responsible Party
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Principal Investigators
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Rakesh Sindhi, MD
Role: STUDY_DIRECTOR
Plexision
Locations
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Erie County Medical Center
Buffalo, New York, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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00033434
Identifier Type: -
Identifier Source: org_study_id
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