Cell-based Assays for Antibody-mediated Transplant Rejection

Antibody-Mediated Graft Rejection Clinical Trial

Official title:

Validating Cell-based Assays for ABMR After Renal Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03916822
• Other study ID #: 00033434
• Status: Recruiting
• Start date: April 15, 2019
• Est. completion date: August 14, 2021

Study information

• Verified date: September 2020
• Source: Plexision
• Contact: Rakesh Sindhi, MD
• Phone: 412-224-2507
• Email: rakesh[@]plexision.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 14, 2021
• Est. primary completion date: June 14, 2021
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibody-Mediated Graft Rejection

Intervention

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

Locations

Country	Name	City	State
United States	Erie County Medical Center	Buffalo	New York
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Plexision	Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody-mediated rejection	Biopsy-proven antibody-mediated rejection after primary renal transplantation	up to 90 days per subject
Secondary	T-cell mediated rejection (TCMR)	Biopsy-proven TCMR after primary renal transplantation	up to 90 days per subject