Correlation of Donor-specific Anti-endothelial Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01545713
Recruitment Status : Active, not recruiting
First Posted : March 7, 2012
Last Update Posted : September 21, 2017
Information provided by (Responsible Party):
John Friedewald, Northwestern University

Brief 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.

Condition or disease
Living-Donor Kidney Transplants

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Renal Transplant Recipients
Patients undergoing living-donor kidney transplant at NMH who have a positive XM-One AbSorber® positive test result.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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
A total of 40 cc/3 tablespoons of blood will be drawn once.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Living-Donor kidney transplant recipients at Northwestern Memorial Hospital 18 year of age or older.

Inclusion Criteria:

  1. patients older than 18 years of age
  2. patients undergoing living-donor kidney transplant at NMH who have a positive XM-One AbSorber® positive test result

Exclusion Criteria:

  1. patients undergoing deceased donor kidney transplant
  2. patients younger than 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01545713

United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Principal Investigator: John Friedewald, MD Northwestern University

Responsible Party: John Friedewald, Associate Professor of Medicine and Surgery, Northwestern University Identifier: NCT01545713     History of Changes
Other Study ID Numbers: XM-One AbSorber
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: August 2017

Keywords provided by John Friedewald, Northwestern University:
living donor