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Correlation of Donor-specific Anti-endothelial Cells

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
John Friedewald, Northwestern University
ClinicalTrials.gov Identifier:
NCT01545713
First received: March 1, 2012
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  Purpose

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 HLA antigens. 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
Living-Donor Kidney Transplants

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • To complete additional testing for accuracy [ Time Frame: June 2011 - February 2012 ] [ Designated as safety issue: No ]
    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:
  • To assess the frequency of autologous antibodies. [ Time Frame: June 2011 - February 2012 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: June 2011
Estimated Study Completion Date: May 2014
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Renal Transplant Recipients
Patients undergoing living-donor kidney transplant at NMH who have a positive XM-One AbSorber® positive test result.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545713

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

No publications provided

Responsible Party: John Friedewald, Associate Professor of Medicine and Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT01545713     History of Changes
Other Study ID Numbers: XM-One AbSorber
Study First Received: March 1, 2012
Last Updated: April 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
renal
kidney
transplant
living donor

ClinicalTrials.gov processed this record on May 16, 2013