Antibody-Mediated Graft Rejection Clinical Trial
Official title:
Validating Cell-based Assays for ABMR After Renal Transplantation
NCT number | NCT03916822 |
Other study ID # | 00033434 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 15, 2019 |
Est. completion date | August 14, 2021 |
Verified date | September 2020 |
Source | Plexision |
Contact | Rakesh Sindhi, MD |
Phone | 412-224-2507 |
rakesh[@]plexision.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | August 14, 2021 |
Est. primary completion date | June 14, 2021 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Erie County Medical Center | Buffalo | New York |
United States | Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Plexision | Medical University of South Carolina |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03393793 -
HEart trAnsplantation Registry of piTie-Salpetriere University Hospital
|