Thymoglobulin Induction Therapy With Minimal Immunosuppression and Evaluation of Allograft Status

NCT00731874 | Terminated Phase 4 Results

• 1 other identifier: 0608008711
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Immunosuppression

Keywords

Kidney transplantation; Immunosuppression; Minimization; Tacrolimus; Prograf; Thymoglobulin

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Biopsy-confirmed Acute Rejection and/or Progression of Histologically Proven Chronic Allograft Nephropathy at 15 Months After Transplantation.

  15 months post-transplant

Secondary Outcomes (9)

• Patient Survival

  36 months post-transplant

• Graft Survival

  36 months post-transplant

• Change in Incidence and Severity of Interstitial Fibrosis/Tubular Atrophy (IF/TA) From the Baseline 3-month Biopsy to the 36-month Biopsy

  36 months post-transplant

• Renal Function (Estimated Glomerular Filtration Rate)

  36 months post-transplant

• Development of Donor Specific Antibody (DSA)

  36 months post-transplant

Study Arms (2)

Arm 1 (6 to 8 ng/mL)

ACTIVE COMPARATOR

Target tacrolimus trough concentration of 6 to 8 ng/mL

Drug: Tacrolimus

Arm 2 (3 to 5 ng.mL)

ACTIVE COMPARATOR

Target tacrolimus trough concentration of 3 to 5 ng/mL

Drug: Tacrolimus

Interventions

Tacrolimus DRUG

Dosed to achieve target trough concentrations.

Also known as: Prograf

Arm 1 (6 to 8 ng/mL); Arm 2 (3 to 5 ng.mL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College/NewYork-Presbyterian Hospital

New York, New York, 10065, United States

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Limitations and Caveats

The population reported is small because the study was stopped early due to the increase in late antibody mediated rejection (occurring after month 15) that was seen in Arm 2 (target tacrolimus trough 3 to 5 ng/mL).

Results Point of Contact

• Title: Dr. Meredith J Aull
• Organization: Weill Cornell Medical College/Division of Transplant Surgery

mea9008@med.cornell.edu

(212) 746-0727

Study Officials

• Sandip Kapur, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 11, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 12, 2019
• Results First Posted: February 1, 2016

Record last verified: 2019-05

Locations

US (1)