Correlation of Donor-specific Anti-endothelial Cells
|ClinicalTrials.gov Identifier: NCT01545713|
Recruitment Status : Active, not recruiting
First Posted : March 7, 2012
Last Update Posted : September 21, 2017
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.
|Condition or disease|
|Living-Donor Kidney Transplants|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||16 participants|
|Official Title:||A Phase II, Prospective, Single-center Study: Correlation of Donor-specific Anti-precursor Endothelial Cells With Transplant Outcome for Recipients of Living-donor Kidney Transplants, Are Auto-antibodies Important.|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||February 2012|
|Estimated Study Completion Date :||April 2018|
Renal Transplant Recipients
Patients undergoing living-donor kidney transplant at NMH who have a positive XM-One AbSorber® positive test result.
- To complete additional testing for accuracy [ Time Frame: June 2011 - February 2012 ]The primary objective is to complete additional testing for accuracy to determine whether antibodies directed at donor-specific endothelial cell effect transplant outcome.
- To assess the frequency of autologous antibodies. [ Time Frame: June 2011 - February 2012 ]To assess the frequency of autologous antibodies that may be falsely reported as donor-specific anti-endothelial antibodies in our patient population. The single center research study we here at Northwestern University have been working on since May 19, 2010 thus far has resulted in 19 out of 150 specimens tested, have positive results based on the XM-One AbSorber® assay.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545713
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||John Friedewald, MD||Northwestern University|