NCT00275535

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Kidney Diseases

Interventions

Type	Name	Description
DRUG	Anti-thymocyte globulin	Thymoglobulin 1.5 mg/kg/d (days 0,1,2,4,6)
DRUG	Mycophenolate mofetil	Mycophenolate mofetil 750 mg p.o. b.i.d.- maintenance
DRUG	Prednisone	Prednisone 500 mg/day initially, tapered to 5 mg/day by day 92
DRUG	Tacrolimus	Tacrolimus - maintain trough levels of 6-8 ng/ml (whole blood Imx assay)
DRUG	Sirolimus	Rapamycin 3 to 5 mg/day; adjust to the high-performance liquid chromatography (HPLC) blood level 15 to 20 ng ml

Timeline

• Start date: 2001-04-01
• Primary completion: 2007-11-01
• Completion: 2008-12-01
• First posted: 2006-01-12
• Last updated: 2011-12-08

Locations

1 site across 1 country: United States