Kidney Transplantation Clinical Trial
— ARTISTOfficial title:
An Observational Study to Assess the Prevalence of a Tolerance Signature in Renal Transplant Recipients (ITN524ST/CTOT-12)
This is an observational study for people who have received a kidney transplant within the past 1 to 5 years. Researchers in this study are looking for a certain pattern of genes and cells in the blood that has been found in a group of rare transplant patients who do not need immunosuppression. The study goal is to find out how common this pattern is in transplant patients, as a first step in determining if it can be used to personalize anti-rejection drug regimens better.
Status | Completed |
Enrollment | 250 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Received first kidney transplant from a living or deceased donor. - Kidney transplanted between 1 and 5 years ago. - Calculated GFR of greater than or equal to 45 mL/min/1.73 m2 within last 6 months - Ability to understand and provide informed consent. Exclusion Criteria: - History of steroid-resistant acute rejection - History of two or more episodes of acute rejection - Any acute rejection in the past year - Current malignancy - Transplant of another organ - AIDS according to the CDC definition of AIDS. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
United States | University of Alabama Birmingham | Birmingham | Alabama |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Northwestern University | Chicago | Illinois |
United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Mount Sinai School of Medicine | New York | New York |
United States | University of California San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Clinical Trials in Organ Transplantation, Immune Tolerance Network (ITN) |
United States,
Newell KA, Asare A, Kirk AD, Gisler TD, Bourcier K, Suthanthiran M, Burlingham WJ, Marks WH, Sanz I, Lechler RI, Hernandez-Fuentes MP, Turka LA, Seyfert-Margolis VL; Immune Tolerance Network ST507 Study Group.. Identification of a B cell signature associated with renal transplant tolerance in humans. J Clin Invest. 2010 Jun;120(6):1836-47. doi: 10.1172/JCI39933. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The presence of at least one time point of the previously identified renal transplant tolerance signature. | 2 years | No | |
Secondary | Time course of potential changes in the previously identified renal transplant tolerance signature in individual participants. | 2 years | No | |
Secondary | Expression levels for a wide variety of genes measured by large-scale microarray or by PCR assessments | 2 years | No | |
Secondary | Flow-cytometric measurements of cell populations distinguished by cell-surface phenotype | 2 years | No | |
Secondary | Selected clinical events and laboratory parameters to assess hematologic and renal function | 2 years | No |
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