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

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Kidney Diseases

Treatments: Drug: Anti-thymocyte globulin; Drug: Prednisone; Drug: Mycophenolate mofetil; Drug: Tacrolimus; Drug: Sirolimus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00275535

124-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 165 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 2 patient groups

Tacrolimus

Active Comparator group

Description:

Calcineurin inhibitor arm, consisting of treatment with tacrolimus, mycophenolate mofetil, and prednisone.

Treatment:

Drug: Tacrolimus

Drug: Mycophenolate mofetil

Drug: Prednisone

Drug: Anti-thymocyte globulin

Sirolimus

Active Comparator group

Description:

Calcineurin inhibitor-free arm, consisting of treatment with rapamycin, mycophenolate mofetil, and prednisone.

Treatment:

Drug: Sirolimus

Drug: Mycophenolate mofetil

Drug: Prednisone

Drug: Anti-thymocyte globulin