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

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Diseases

Intervention: Anti-thymocyte globulin (Drug); Mycophenolate mofetil (Drug); Prednisone (Drug); Tacrolimus (Drug); Sirolimus (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Mark D. Stegall, M.D., Principal Investigator, Affiliation: Mayo Clinic


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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Glomerular filtration rate (GFR) (iothalamate clearance) at 12 months following transplantation

Secondary outcome:

GFR (iothalamate clearance) at other time points

Other measures of renal function (serum creatinine, proteinuria and albuminuria)

Acute rejection both early and after tacrolimus withdrawal

Patient and graft survival

Complications-especially hypertension, diabetes, dyslipidemia

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.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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

Locations and Contacts

Mayo Clinic, Rochester, Minnesota 55905, United States
Additional Information

Mayo Clinic Clinical Trials

Starting date: April 2001
Last updated: December 6, 2011

Page last updated: August 20, 2015

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