Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients

A Randomized, Open-Label Study to Compare the Rate of New Non-Melanoma Skin Cancer in Maintenance Renal Allograft Recipients Converted to a Sirolimus-based Regimen Versus Continuation of a Calcineurin Inhibitor-based Regimen

The purpose of this study is to determine the effect of sirolimus on the prevention of new non-melanoma skin cancer (NMSC) in kidney transplant recipients.

Inclusion Criteria:

• Kidney transplant at least 1 year prior
• Subjects with a functioning renal allograft with calculated glomerular filtration rate (GFR) ≥40mL/min (Nankivell method) and proteinuria ≤500mg/day.
• Stable on cyclosporine or tacrolimus-based multi-drug immunosuppressive regimen
• History of NMSC within last 3 years

Exclusion Criteria:

• History of other cancer within last 3 years
• NMSC with metastatic disease or more than 20 NMSC lesions in last 12 months
• Multiple organ transplant