Associating Renal Transplantation With the ITN Signature of Tolerance
Condition: Kidney Transplantation
Study type: Observational

Summary: 
      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: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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
      
Biospecimen description: 
      Whole blood Isolation PBMC isolated RNA specimens
    
Keywords: Kidney Transplantation; kidney transplant; renal transplant; immunosuppression