Associating Renal Transplantation With the ITN Signature of Tolerance

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Observational Study to Assess the Prevalence of a Tolerance Signature in Renal Transplant Recipients (ITN524ST/CTOT-12)

Conditions
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Kidney Transplantation

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Renal Transplant Recipients<br>Subjects who received a kidney transplant within the past 1 to 5 years | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of at least one time point of the previously identified renal transplant tolerance signature. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time course of potential changes in the previously identified renal transplant tolerance signature in individual participants. |  | 2 years | 
| Expression levels for a wide variety of genes measured by large-scale microarray or by PCR assessments |  | 2 years | 
| Flow-cytometric measurements of cell populations distinguished by cell-surface phenotype |  | 2 years | 
| Selected clinical events and laboratory parameters to assess hematologic and renal function |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Transplantation, kidney transplant, renal transplant, immunosuppression