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Genomics of Chronic Renal Allograft Rejection (The GoCAR Study)

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ClinicalTrials.gov Identifier: NCT00611702
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : May 14, 2015
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Doctors have had success preventing certain types of kidney transplant rejection by suppressing the immune system. However, an individual's genetic make-up and the strength of an immune response to a transplant may also determine whether a transplanted organ is rejected. The purpose of this study is to look at the genetic profile and immune response of people who have had kidney transplants and to correlate the findings with kidney transplant rejection episodes. Donor genetic profiles will also be studied and correlated with the recipient's information.

Condition or disease Intervention/treatment
Kidney Transplantation Procedure: Kidney biopsy

Detailed Description:

New immunosuppressive drugs have improved short-term transplant survival but have not affected long-term transplant survival. Rejection is caused by both immunological and non-immunological factors from both the donor and the recipient. Although the exact cause of chronic rejection is not known, it is associated with the presence of C4d, a degradation product of the antibody response cascade, and the presence of circulating donor-specific antibodies (DSAs). The purpose of this study is to determine the role of cell- and antibody-mediated responses in chronic rejection of transplants, to determine the gene expression profile associated with the development of chronic rejection, and to determine whether variants of specific genes cause susceptibility to rejection.

This is an observational study of people who will be receiving kidney transplants and participants will be followed for 2 years. Study visits for kidney transplant recipients will occur at study entry and at months 3, 6, 12, 18, and 24 after transplant. At these visits, adverse event assessment, rejection assessment, medication history questionnaire, and blood collection will occur. At some visits, a physical exam and a kidney biopsy will occur. Blood will also be collected from living kidney donors at the time of donation if both donor and recipient agree to be in the study. This study will be take place at 4 clinical sites: Mount Sinai School of Medicine, University of Wisconsin-Madison, Westmead Hospital, and Northwestern Memorial Hospital. Brigham and Women's Hospital and Massachusetts General Hospital will also participate in the study as central laboratories.


Study Design
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Study Type : Observational
Actual Enrollment : 588 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genomics of Chronic Renal Allograft Rejection
Study Start Date : June 2008
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
    Procedure: Kidney biopsy
    Kidney biopsy (recipients only) will be obtained for RT-PCR, microarray analyses and histology.

Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Correlation of chronic rejection with patterns and intensity of recipient alloreactivity [ Time Frame: Throughout study ]
  2. Correlation of chronic rejection with recipient gene expression profiles [ Time Frame: Throughout study ]
  3. Correlation of chronic rejection with polymorphic variants of specific susceptibility genes in donor and recipient [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. Correlation of the development of donor specific antibodies after transplant and/or the presence of C4d staining with patterns and intensity of recipient alloreactivity [ Time Frame: Throughout study ]
  2. Correlation of the development of donor specific antibodies after transplant and/or the presence of C4d staining with recipient gene expression profiles [ Time Frame: Throughout study ]
  3. Correlation of the development of donor-specific antibodies after transplant and/or the presence of C4d staining of peritubular basement membranes on renal biopsy with polymorphic variants of specific susceptibility genes in donor and recipient [ Time Frame: Throughout study ]
  4. Correlation of the development of donor-specific antibodies after transplant and/or the presence of C4d staining of peritubular basement membranes on renal biopsy with chronic rejection [ Time Frame: Throughout study ]
  5. Correlation of the development of donor-specific antibodies after transplant and/or the presence of C4d staining of peritubular basement membranes on renal biopsy allograft dysfunction as defined by the protocol [ Time Frame: Throughout study ]

Biospecimen Retention:   Samples With DNA
Blood from both kidney donor and recipient and transplant kidney biopsy samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals receiving a kidney transplant and individuals who are donating a kidney
Criteria

Inclusion Criteria:

  • Kidney transplant candidates from living or deceased donors
  • Male or female, ages 18-75 years
  • Subject must be able to understand and provide written informed consent
  • Living Donors - Recipient also consents to participate in the study

Exclusion Criteria:

  • Presence of Donor Specific Antibodies in living donor recipients prior to transplantation OR positive cross match according to site-specific technique in cadaveric donor recipients
  • Recipients of multiple organ transplants, with the exception of kidney/pancreas transplants.
  • Inability or unwillingness to comply with the study protocol.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00611702


Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
Mt. Sinai School of Medicine
New York, New York, United States, 10029
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53706
Australia, New South Wales
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Barbara T. Murphy, MD Division of Nephrology, Mt. Sinai School of Medicine
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
National Institute of Allergy and Infectious Diseases (NIAID)  This link exits the ClinicalTrials.gov site

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00611702     History of Changes
Other Study ID Numbers: DAIT GTCRP-01
First Posted: February 11, 2008    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: May 2015

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
ELISPOT
RT-PCR
Luminex
Genomics