The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients

December 6, 2011 updated by: Mayo Clinic

A Prospective, Randomized Trial of Calcineurin-Inhibitor Withdrawal in Renal Allograft Recipients

This study was done to find out which treatment, tacrolimus or sirolimus, leads to better long-term kidney function in kidney transplant patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study was to compare the complete avoidance of calcineurin inhibitors (CI) using a sirolimus-based immunosuppressive regimen to a tacrolimus-based regimen in kidney transplantation. This study was a prospective open-label trial randomizing patients to receive tacrolimus, mycophenolate mofetil and prednisone or sirolimus, mycophenolate mofetil and prednisone. All patients received antithymocyte globulin induction. All rejection episodes were proven by biopsy. The hypothesis was that CI free immunosuppression after kidney transplantation will lead to an increase in glomerular filtration rate (GFR) at one year after kidney transplantation.

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Living and deceased donor kidney transplant recipients at the Mayo Clinic, Rochester, Minnesota

Exclusion Criteria:

  • Patients with type 1 diabetes less than 50 years of age who receive a living donor kidney transplant followed by a pancreas transplant
  • Pediatric patients (<18 years of age)
  • Multi-organ transplants (e.g., kidney-pancreas, kidney-liver)
  • ABO-incompatible or positive crossmatch recipients (ABO incompatibility is an immune system reaction that occurs when blood from two different and incompatible blood types are mixed together.)
  • Patients with severe hyperlipidemia (serum cholesterol >350 mg/dl or serum triglycerides >500 mg/dl
  • Patients with severe leukopenia (White Blood Cell count [WBC]<3000 10^3/ml)
  • Patients unwilling to return to the transplant center for late follow-up visits
  • Body mass index (BMI) ≥ 32 with incisional problems post transplant (as determined by renal transplant surgeon

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tacrolimus
Calcineurin inhibitor arm, consisting of treatment with tacrolimus, mycophenolate mofetil, and prednisone.
Drug: Anti-thymocyte globulin
Thymoglobulin 1.5 mg/kg/d (days 0,1,2,4,6)
Other Names:
  • Thymoglobulin
  • Atgam
Drug: Mycophenolate mofetil
Mycophenolate mofetil 750 mg p.o. b.i.d.- maintenance
Other Names:
  • CellCept
Drug: Prednisone
Prednisone 500 mg/day initially, tapered to 5 mg/day by day 92
Other Names:
  • Deltasone
  • Orasone
  • Meticorten
  • Prednicen-M
  • Liquid Pred
  • Prednicot
  • Sterapred
  • Sterapred DS
Drug: Tacrolimus
Tacrolimus - maintain trough levels of 6-8 ng/ml (whole blood Imx assay)
Other Names:
  • Prograf
  • Protopic
  • Advagraf
Active Comparator: Sirolimus
Calcineurin inhibitor-free arm, consisting of treatment with rapamycin, mycophenolate mofetil, and prednisone.
Drug: Anti-thymocyte globulin
Thymoglobulin 1.5 mg/kg/d (days 0,1,2,4,6)
Other Names:
  • Thymoglobulin
  • Atgam
Drug: Mycophenolate mofetil
Mycophenolate mofetil 750 mg p.o. b.i.d.- maintenance
Other Names:
  • CellCept
Drug: Prednisone
Prednisone 500 mg/day initially, tapered to 5 mg/day by day 92
Other Names:
  • Deltasone
  • Orasone
  • Meticorten
  • Prednicen-M
  • Liquid Pred
  • Prednicot
  • Sterapred
  • Sterapred DS
Drug: Sirolimus
Rapamycin 3 to 5 mg/day; adjust to the high-performance liquid chromatography (HPLC) blood level 15 to 20 ng ml
Other Names:
  • Rapamune

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glomerular filtration rate (GFR) (iothalamate clearance) at 12 months following transplantation
Time Frame: 12 months following transplantation
Glomerular filtration rate (Iothalamate clearance) at 12 months following transplantation.
12 months following transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
GFR (iothalamate clearance) at other time points
Time Frame: 24 months
24 months
Other measures of renal function (serum creatinine, proteinuria and albuminuria)
Time Frame: 24 months
24 months
Acute rejection both early and after tacrolimus withdrawal
Time Frame: 24 months
24 months
Patient and graft survival
Time Frame: 24 months after transplantation
24 months after transplantation
Complications-especially hypertension, diabetes, dyslipidemia
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer
Roche Pharma AG
Genzyme, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

January 10, 2006

First Submitted That Met QC Criteria

January 10, 2006

First Posted (Estimate)

January 12, 2006

Study Record Updates

Last Update Posted (Estimate)

December 8, 2011

Last Update Submitted That Met QC Criteria

December 6, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 124-01 (KWC IRB / REC No.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe