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Thymoglobulin Induction Therapy With Minimal Immunosuppression and Evaluation of Allograft Status (TIMELY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Sandip Kapur, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00731874
First received: August 7, 2008
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Kidney Transplant
Immunosuppression
Drug: Tacrolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Thymoglobulin Induction Therapy With Minimal Immunosuppression and Evaluation of Allograft Status by Biopsy and mRNA Profiles (TIMELY Study)

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • The primary endpoint will be a composite of the following: biopsy-confirmed acute rejection and progression of histologically proven chronic allograft nephropathy at 15 months after transplantation. [ Time Frame: 15 months post-transplant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Patient survival [ Time Frame: 12, 18, 24, 36 months post-transplant ] [ Designated as safety issue: Yes ]
  • Graft survival [ Time Frame: 12, 18, 24, 36 months post-transplant ] [ Designated as safety issue: Yes ]
  • Incidence and severity of chronic allograft nephropathy [ Time Frame: 12, 24, 36 months post-transplant ] [ Designated as safety issue: Yes ]
  • Renal function (estimated glomerular filtration rate) [ Time Frame: 12, 18, 24, 36 months post-transplant ] [ Designated as safety issue: Yes ]
  • Perforin and granzyme B mRNA levels in urine [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
  • Time to acute rejection [ Time Frame: 12, 24, 36 months post-transplant ] [ Designated as safety issue: Yes ]
  • Severity of acute rejection (by Banff criteria and need for anti-lymphocyte agents to treat acute rejection) [ Time Frame: 12, 24, 36 months post-transplant ] [ Designated as safety issue: Yes ]
  • Incidence of opportunistic infection [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Development of new onset diabetes mellitus [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: August 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Target tacrolimus trough concentration of 6 to 8 ng/mL
Drug: Tacrolimus
Dosed to achieve target trough concentrations.
Other Name: Prograf
Active Comparator: 2
Target tacrolimus trough concentration of 3 to 5 ng/mL
Drug: Tacrolimus
Dosed to achieve target trough concentrations.
Other Name: Prograf

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731874

Locations
United States, New York
Weill Cornell Medical College/NewYork-Presbyterian Hospital Recruiting
New York, New York, United States, 10065
Contact: Meredith J Aull, Pharm.D.    212-746-0727    mea9008@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Sandip Kapur, M.D. Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Sandip Kapur, Associate Professor of Surgery, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00731874     History of Changes
Other Study ID Numbers: 0608008711
Study First Received: August 7, 2008
Last Updated: July 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Kidney transplant
Immunosuppression
Minimization
Tacrolimus
Prograf
Thymoglobulin

Additional relevant MeSH terms:
Tacrolimus
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014