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

A Randomized, Open-label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipients

The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.

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