Antibody-Mediated Graft RejectionNCT03916822
Cell-based Assays for Antibody-mediated Transplant Rejection
An observational study of Antibody-Mediated Graft Rejection, run by Plexision at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Antibody-Mediated Graft Rejection
- What is being tested?
- Alloantigen-specific B-cells
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Apr 2019to 14 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Adults who have received primary renal transplants
Who may be able to join
- IRB-approved informed consent.
- Adults (>18 yr to 70 years)
- Primary renal transplant recipients with biopsy-proven ABMR, TCMR or recipients with no rejection
Who cannot join
- Lack of informed consent
- Concomitant BK virus infection
- Vulnerable populations including children <18 yr, pregnant women, and prisoners
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Not yet recruiting
Erie County Medical Center
Buffalo, New York, 14215
Liise Kayler, MD, 716-361-8500, LKayler@ecmc.edu
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Rohan Vinayak, rohanv@musc.edu
About this study
Official title: Validating Cell-based Assays for ABMR After Renal Transplantation
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.
Read the 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.
- Conditions
- Antibody-Mediated Graft Rejection
- Being tested
- Alloantigen-specific B-cells
- Keywords
- Antibody mediated Rejection, Renal Transplantation, Adults, CD154, B-cells, B-cell subsets, alloantigen-specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alloantigen-specific B-cellsDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| ABMR | Biopsy-proven ABMR-Banff criteria, with or without Complement binding donor-specific anti-HLA antibodies Receives: Diagnostic Test: Alloantigen-specific B-cells | |
| TCMR | Biopsy-proven TCMR-Banff 1A, 1B, 2 and 3 Receives: Diagnostic Test: Alloantigen-specific B-cells | |
| No Rejection | Biopsy-proven, or clinical criteria Receives: Diagnostic Test: Alloantigen-specific B-cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody-mediated rejection
Biopsy-proven antibody-mediated rejection after primary renal transplantation
Measured: up to 90 days per subject
Secondary outcomes (1)
T-cell mediated rejection (TCMR)
Biopsy-proven TCMR after primary renal transplantation
Measured: up to 90 days per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start15 Apr 2019
- Primary completion14 Jun 2021 (estimated)
- Study completion14 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibody-Mediated Graft RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Plexision
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Rakesh Sindhi, MD, Study director, Plexision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916822
- Sponsor's protocol ID
- 00033434
- Status last verified
- Sep 2020
- First submitted
- 12 Apr 2019
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating Cell-based Assays for ABMR After Renal Transplantation
- ClinicalTrials.gov ID
- NCT03916822
- Acronym / sponsor ID
- 00033434
- Conditions
- Antibody-Mediated Graft Rejection
- Keywords
- Antibody mediated Rejection, Renal Transplantation, Adults, CD154, B-cells, B-cell subsets, alloantigen-specific
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- PlexisionIndustry (pharma, biotech, devices)
- Collaborators
- Medical University of South Carolina
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 14 Jun 2021 (estimated)
- Study completion
- 14 Aug 2021 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABMR | – | Diagnostic Test: Alloantigen-specific B-cellsBiopsy-proven ABMR-Banff criteria, with or without Complement binding donor-specific anti-HLA antibodies |
| TCMR | – | Diagnostic Test: Alloantigen-specific B-cellsBiopsy-proven TCMR-Banff 1A, 1B, 2 and 3 |
| No Rejection | – | Diagnostic Test: Alloantigen-specific B-cellsBiopsy-proven, or clinical criteria |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults who have received primary renal transplants
Key inclusion criteria (3 listed)
- IRB-approved informed consent.
- Adults (>18 yr to 70 years)
- Primary renal transplant recipients with biopsy-proven ABMR, TCMR or recipients with no rejection
Key exclusion criteria (3 listed)
- Lack of informed consent
- Concomitant BK virus infection
- Vulnerable populations including children <18 yr, pregnant women, and prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alloantigen-specific B-cellsAlloantigen-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 | Diagnostic test | ABMR, No Rejection, TCMR |
Primary outcome
Antibody-mediated rejection
Time frame: up to 90 days per subject
Biopsy-proven antibody-mediated rejection after primary renal transplantation
1 secondary outcome
T-cell mediated rejection (TCMR)
Time frame: up to 90 days per subject
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rakesh Sindhi, MD study director
Plexision
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibody-Mediated Graft Rejection, run by Plexision at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rakesh Sindhi, MD (412-224-2507, rakesh@plexision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody-mediated rejection (time frame: up to 90 days per subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020.