Recruiting

Transplant Rejection

Sponsor:

Plexision

Code:

NCT03916822

Conditions

Antibody-Mediated Graft Rejection

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Alloantigen-specific B-cells

Study Details

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.

Conditions

Antibody-Mediated Graft Rejection

Study ID

NCT03916822

Start date

Apr 15, 2019

Status verified date

Sep, 2020

Completion date

Aug 14, 2021

Anticipated

Primary completion date

Jun 14, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

ABMR

Biopsy-proven ABMR-Banff criteria, with or without Complement binding donor-specific anti-HLA antibodies

TCMR

Biopsy-proven TCMR-Banff 1A, 1B, 2 and 3

No Rejection

Biopsy-proven, or clinical criteria

Interventions

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

Primary outcome measure

  • Antibody-mediated rejection [ Time Frame: up to 90 days per subject ]

Central Contacts and Locations

Central contacts

Rakesh Sindhi, MD

412-224-2507rakesh@plexision.com

Ashok Reddy

301-651-3367ashok.reddy@plexision.com

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Rohan Vinayak

rohanv@musc.edu

More Information

Sponsor

Plexision

Last update posted

Sep 23, 2020

Last verified

Sep, 2020

Keywords

  • Antibody mediated Rejection
  • Renal Transplantation
  • Adults
  • CD154
  • B-cells
  • B-cell subsets
  • alloantigen-specific

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Plexision on 2020-09-23.