Cell-based Assays for Antibody-mediated Transplant Rejection

Status unconfirmed

Conditions studied: Antibody-Mediated Graft Rejection

In brief

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.

Key facts

Study ID

NCT03916822

Run by

Plexision

People needed

30

Starts

2019-04-15

Expected to finish

2021-08-14

Last updated by the study team

2020-09-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• Erie County Medical Center — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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