Thymoglobulin Induction Therapy With Minimal Immunosuppression and Evaluation of Allograft Status

• Status: Terminated
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Tacrolimus

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