Cell-based Assays for Antibody-mediated Transplant Rejection
Validating Cell-based Assays for ABMR After Renal Transplantation
1 other identifier
observational
30
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2019
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2019
CompletedStudy Start
First participant enrolled
April 15, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2021
CompletedSeptember 23, 2020
September 1, 2020
2.2 years
April 12, 2019
September 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Antibody-mediated rejection
Biopsy-proven antibody-mediated rejection after primary renal transplantation
up to 90 days per subject
Secondary Outcomes (1)
T-cell mediated rejection (TCMR)
up to 90 days per subject
Study Arms (3)
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 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
Eligibility Criteria
Adults who have received primary renal transplants
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Plexisionlead
- Medical University of South Carolinacollaborator
Study Sites (2)
Erie County Medical Center
Buffalo, New York, 14215, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Biospecimen
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
Study Officials
- STUDY DIRECTOR
Rakesh Sindhi, MD
Plexision
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2019
First Posted
April 16, 2019
Study Start
April 15, 2019
Primary Completion
June 14, 2021
Study Completion
August 14, 2021
Last Updated
September 23, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share
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