Cell-based Assays for Antibody-mediated Transplant Rejection

NCT03916822 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2020-09-23

No results posted yet for this study

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.

Conditions

  • Antibody-Mediated Graft Rejection

Interventions

DIAGNOSTIC_TEST

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

Sponsors & Collaborators

  • Medical University of South Carolina

    collaborator OTHER
  • Plexision

    lead INDUSTRY

Principal Investigators

  • Rakesh Sindhi, MD · Plexision

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2021-06-14
Completion
2021-08-14

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03916822 on ClinicalTrials.gov