Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients

• Drug: Sirolimus
  
  Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled
• Drug: tacrolimus
• Drug: Cyclosporine A

• Active Comparator: A
  
  Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
  Interventions:
  

  • Drug: Sirolimus
  • Drug: tacrolimus
  • Drug: Cyclosporine A
• Active Comparator: B
  
  Continued calcineurin inhibitor therapy
  Interventions:
  

  • Drug: Sirolimus
  • Drug: tacrolimus
  • Drug: Cyclosporine A

Inclusion Criteria:

• Age greater than or equal to 13 years.
• Receiving CsA or tacrolimus from the time of transplantation or within 2 weeks thereafter
• Patients with a functioning allograft and a Nankivell GFR greater than or equal to 20 mL/min, within 2 weeks before randomization

Exclusion Criteria:

• Biopsy-confirmed acute rejection within 12 weeks before randomization, that was determined to require antirejection treatment
• Patients in whom kidney-pancreas or other multiple organ transplants have been performed