Associating Renal Transplantation With the ITN Signature of Tolerance
NCT ID: NCT01516177
Last Updated: 2016-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
250 participants
OBSERVATIONAL
2010-09-30
2014-04-30
Brief Summary
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Detailed Description
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The ITN Registry of Tolerant Kidney Transplant Recipients recently identified a rare group of people whose immune system has accepted their transplant without continued use of immunosuppressive drugs. Researchers have found that these patients have a unique pattern of cells and genes expressed in their blood compared to other transplant patients.
The ARTIST study will ask the questions "Are there other transplant patients who show this pattern?" and "If so, how often?"
The goal is to find out if there are other transplant patients who are taking immunosuppression who also show this pattern of genes. If there are others, then this pattern may one day be useful in identifying transplant patients who could reduce the dose of immunosuppression they need without fear of rejection.
Researchers are seeking adults who have received a kidney transplant within the past 1 to 5 years. Participants will be asked to attend 3 short appointments with study doctors over a period of 2 years. At these visits, doctors will request demographic and clinical information, relevant medical histories and blood and urine samples. Participants will be compensated for their time.
It is important to note that this is an observational study only. Other than receiving consultations and advice from the transplant team, there is no direct medical benefit to participating. However, by participating, patients may play an active part in helping doctors learn to control kidney transplant rejection more effectively, with fewer drugs.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Renal Transplant Recipients
Subjects who received a kidney transplant within the past 1 to 5 years
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Immune Tolerance Network (ITN)
NETWORK
Clinical Trials in Organ Transplantation
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Anil Chandraker, MD
Role: STUDY_CHAIR
Brigham and Women's Hospital
Kenneth Newell, MD, PhD
Role: STUDY_CHAIR
Emory University
Laurence Turka, MD
Role: STUDY_CHAIR
Beth Israel Deaconess Medical Center
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
University of California San Francisco
San Francisco, California, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mount Sinai School of Medicine
New York, New York, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Countries
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References
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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. Epub 2010 May 24.
Related Links
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National Institute of Allergy and Infectious Diseases (NIAID) website
Immune Tolerance Network website
Clinical Trials in Organ Transplantation website
Other Identifiers
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DAIT ITN524ST/CTOT-12
Identifier Type: -
Identifier Source: org_study_id