Cell-based Assays for Antibody-mediated Transplant Rejection

• Conditions: Antibody-Mediated Graft Rejection

• Registration Number: NCT03916822
• Lead Sponsor: Plexision

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.

Study Timeline

• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-12
• Study Start: 2019-04-15
• Study First Posted: 2019-04-16
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-21
• Last Update Posted: 2020-09-23
• Primary Completion: 2021-06-14
• Study Completion: 2021-08-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antibody-mediated rejection	up to 90 days per subject	Biopsy-proven antibody-mediated rejection after primary renal transplantation

Secondary Outcome Measures

Name	Time	Method
T-cell mediated rejection (TCMR)	up to 90 days per subject	Biopsy-proven TCMR after primary renal transplantation

Trial Locations

Locations (2)

Erie County Medical Center; 🇺🇸 Buffalo, New York, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States