Associating Renal Transplantation With the ITN Signature of Tolerance (ARTIST)
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|ClinicalTrials.gov Identifier: NCT01516177|
Recruitment Status : Completed
First Posted : January 24, 2012
Last Update Posted : December 20, 2016
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|Condition or disease|
Following surgery, kidney transplant patients must take medications in order to prevent rejection of their transplanted organ. These medications can be very effective. Called immunosuppressive drugs, they work by reducing the activity of the immune system. Because of this, however, they can also have serious side effects, including increased risks of serious infections and certain types of cancer.
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.
|Study Type :||Observational|
|Actual Enrollment :||250 participants|
|Official Title:||An Observational Study to Assess the Prevalence of a Tolerance Signature in Renal Transplant Recipients (ITN524ST/CTOT-12)|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Renal Transplant Recipients
Subjects who received a kidney transplant within the past 1 to 5 years
- The presence of at least one time point of the previously identified renal transplant tolerance signature. [ Time Frame: 2 years ]
- Time course of potential changes in the previously identified renal transplant tolerance signature in individual participants. [ Time Frame: 2 years ]
- Expression levels for a wide variety of genes measured by large-scale microarray or by PCR assessments [ Time Frame: 2 years ]
- Flow-cytometric measurements of cell populations distinguished by cell-surface phenotype [ Time Frame: 2 years ]
- Selected clinical events and laboratory parameters to assess hematologic and renal function [ Time Frame: 2 years ]
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
The study will include 250 participants who are determined to be eligible for further follow-up based on the eligibility criteria.
Among those eligible for further follow-up
- at least 25 participants will be renal transplant recipients who received induction therapy with Campath, and
- at least 25 participants will be renal transplant recipients who are receiving sirolimus or everolimus at time of enrollment and who have not received calcineurin inhibitors for at least 30 days prior to enrollment
- 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.
- 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.
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): NCT01516177
|United States, Alabama|
|University of Alabama Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94143|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02115|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|United States, Ohio|
|The Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Anil Chandraker, MD||Brigham and Women's Hospital|
|Study Chair:||Kenneth Newell, MD, PhD||Emory University|
|Study Chair:||Laurence Turka, MD||Beth Israel Deaconess Medical Center|
|Responsible Party:||National Institute of Allergy and Infectious Diseases (NIAID)|
|Other Study ID Numbers:||
|First Posted:||January 24, 2012 Key Record Dates|
|Last Update Posted:||December 20, 2016|
|Last Verified:||December 2016|