Status:
TERMINATED
Thymoglobulin Induction Therapy With Minimal Immunosuppression and Evaluation of Allograft Status
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Immunosuppression
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 trans...
Detailed Description
The objective of this study is to assess the safety and efficacy of an immunosuppression-minimizing regimen consisting initially of Thymoglobulin induction in combination with tacrolimus, mycophenolat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00731874
Start Date
August 1 2008
End Date
July 1 2013
Last Update
June 12 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Weill Cornell Medical College/NewYork-Presbyterian Hospital
New York, New York, United States, 10065