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NCT01545713 · ClinicalTrials.gov registry record
Correlation of Donor-specific Anti-endothelial Cells
A clinical trial, sponsored by Northwestern University.
- Completed
- Registry status
- 16
- Enrollment target
NCT01545713: Completed study, sponsored by Northwestern University.
NCT01545713 is a clinical trial that has completed, run by Northwestern University. The registered enrollment target is 16 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01545713 has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- 16 participants
- Enrollment target
Study Summary
Antibody Mediated Rejection (AMR) is a major complication of solid organ transplantation. The main reason for AMR is pre-formed, or de-novo, donor specific antibodies against the donor human leukocyte antigens (HLA). Additional potential targets are antibodies against MIC-A antigens or antibodies against targets expressed on the donor endothelial cells. Until recently, no specific means were available to test for the presence of donor-specific endothelial cell antibodies. The newly introduced XM-One AbSorber® assay allows isolating precursor endothelial cells from donor peripheral blood, and thus assessing the presence of donor-specific endothelial cell antibodies. XM-One AbSorber® is an in-vitro assay that allows for the specific enrichment of precursor endothelial cells which in turn promotes endothelial cells specific cross match testing. This assay is currently being used in an on-going Northwestern University (NU) research study (STU#00029988). The preliminary results of this study indicate that indeed some of the patients test positive against their respective donors. One potential explanation for this observation, that was not previously entertained, is that the antibodies causing the positive cross match response are actually of autoimmune nature. In order to rule-out such a potential explanation the investigators would like to further test these patients by performing an autologous XM-One AbSorber® assay in which the recipient sera will be incubated with the patients' own cells (as opposed to the respective donor cells in the parental study). This information is crucial for proper analysis of the data obtained in the NU STU#00029988 study.
Primary Outcome
The primary objective is to complete additional testing for accuracy to determine whether antibodies directed at donor-specific endothelial cell effect transplant outcome.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2011-06 |
| Est. Completion | 2017-12 |
What the finished NCT01545713 record still lists
NCT01545713 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 16 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01545713 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01545713 about?
NCT01545713 is a clinical study titled "Correlation of Donor-specific Anti-endothelial Cells". Antibody Mediated Rejection (AMR) is a major complication of solid organ transplantation. The main reason for AMR is pre-formed, or de-novo, donor specific antibodies against the donor human leukocyte antigens (HLA). Additional potential targets are antibodies against MIC-A antigens or antibodies ag...
What is the current status of trial NCT01545713?
This trial is currently completed. The enrollment target is 16 participants. The study started on 2011-06. Estimated completion is 2017-12.
Who is sponsoring clinical trial NCT01545713?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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