Thymoglobulin Induction Therapy With Minimal Immunosuppression and Evaluation of Allograft Status
Condition: Immunosuppression
Intervention: Tacrolimus
Intervention description: Dosed to achieve target trough concentrations.
Intervention MeSH terms: Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney transplantation; Immunosuppression; Minimization; Tacrolimus; Prograf; Thymoglobulin

Summary:

      Tacrolimus (Prograf) is a medication that is commonly used in patients who receive a kidney
      transplant. It is considered to be one of the most important medications that prevent
      rejection of the transplant kidney by suppressing the immune system. Although tacrolimus is
      good at preventing rejection, it does have some unwanted side effects. These side effects
      include high blood pressure, increase in blood sugar, headache, and tremor. In addition,
      tacrolimus causes some damage to the transplant kidney over time, by causing healthy tissue
      to turn into scar tissue that does not function as well as healthy tissue. Therefore, kidney
      function may be reduced over time. In the first three months after kidney transplant, Prograf
      levels are kept between 8 to 10 ng/mL. This study will compare two groups of patients that
      will both have their tacrolimus dose reduced slowly over three months to prevent rejection
      while decreasing the risk of causing toxic effects to the kidney. One group will have their
      Prograf levels kept between 6 and 8 ng/mL, while the second group will have their levels kept
      between 3 and 5 ng/mL. We will then compare the two groups to see if there are any
      differences in their kidney function over time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years

          -  Renal allograft recipients who received a steroid-sparing immunosuppression protocol
             with rabbit anti-thymocyte globulin (Thymoglobulin) induction

          -  Patient must have previously enrolled in protocol entitled "The use of urinary PCR
             test to help detect rejection in kidney transplant patients"

          -  Recipients must agree to undergo all standard post-transplant protocol biopsies

          -  Recipients must be at least 3 months post-transplant and the three most recent urinary
             profiles must demonstrate immunologic quiescence as determined by measurement of
             Granzyme B and Perforin copy numbers

          -  Patient must provide informed consent to participate in the research study

        Exclusion Criteria:

          -  Patient is a high-risk recipient (defined as peak or current PRA >50% or a
             re-transplant recipient who lost prior graft within 1 year due to immunologic reasons)

          -  Patients who require maintenance steroids for another medical condition (such as
             asthma)

          -  Patients who are taking less than 1 gram/day of mycophenolate mofetil

          -  Multiple organ transplant recipients (such as kidney-pancreas)

          -  Patients with one or more acute rejection episodes within the first 3 months after
             transplant

          -  Three-month protocol biopsy showing clinical acute rejection (BANFF grade 1a or
             higher)

          -  Patient with documented or suspected non-compliance with transplant medications in the
             first 3 months after transplant