Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cell-based Assays for Antibody-mediated Transplant Rejection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916822
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : September 23, 2020
Sponsor:
Collaborator:
Medical University of South Carolina
Information provided by (Responsible Party):
Plexision

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Antibody-Mediated Graft Rejection Diagnostic Test: Alloantigen-specific B-cells

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Validating Cell-based Assays for ABMR After Renal Transplantation
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : June 14, 2021
Estimated Study Completion Date : August 14, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
ABMR
Biopsy-proven ABMR-Banff criteria, with or without Complement binding donor-specific anti-HLA antibodies
 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
TCMR
Biopsy-proven TCMR-Banff 1A, 1B, 2 and 3
 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
No Rejection
Biopsy-proven, or clinical criteria
 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Antibody-mediated rejection [ Time Frame: up to 90 days per subject ]
    Biopsy-proven antibody-mediated rejection after primary renal transplantation


Secondary Outcome Measures :
  1. T-cell mediated rejection (TCMR) [ Time Frame: up to 90 days per subject ]
    Biopsy-proven TCMR after primary renal transplantation


Biospecimen Retention:   Samples Without DNA
Peripheral blood leukocytes extracted from whole blood samples will be retained in liquid nitrogen for repeat testing or quality assessment until study results are public

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adults who have received primary renal transplants
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916822


Contacts
Layout table for location contacts
Contact: Rakesh Sindhi, MD 412-224-2507 rakesh@plexision.com
Contact: Ashok Reddy 301-651-3367 ashok.reddy@plexision.com

Locations
Layout table for location information
United States, New York
Erie County Medical Center Not yet recruiting
Buffalo, New York, United States, 14215
Contact: Liise Kayler, MD    716-361-8500    LKayler@ecmc.edu   
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Rohan Vinayak       rohanv@musc.edu   
Sponsors and Collaborators
Plexision
Medical University of South Carolina
Investigators
Layout table for investigator information
Study Director: Rakesh Sindhi, MD Plexision
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Plexision
ClinicalTrials.gov Identifier: NCT03916822    
Other Study ID Numbers: 00033434
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will be retained at enrollment sites, Results of testing samples, and related de-identified data of the subject will be summarized and shared with all investigators of this study, and reported in publications

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Plexision:
Antibody mediated Rejection
Renal Transplantation
Adults
CD154
 B-cells
B-cell subsets
alloantigen-specific