Associating Renal Transplantation With the ITN Signature of Tolerance (ARTIST)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||An Observational Study to Assess the Prevalence of a Tolerance Signature in Renal Transplant Recipients (ITN524ST/CTOT-12)|
- The presence of at least one time point of the previously identified renal transplant tolerance signature. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Time course of potential changes in the previously identified renal transplant tolerance signature in individual participants. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Expression levels for a wide variety of genes measured by large-scale microarray or by PCR assessments [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Flow-cytometric measurements of cell populations distinguished by cell-surface phenotype [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Selected clinical events and laboratory parameters to assess hematologic and renal function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole blood Isolation PBMC isolated RNA specimens
|Study Start Date:||September 2010|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Renal Transplant Recipients
People who have received a kidney transplant within the past 1 to 5 years
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|