Comparing Everolimus and Sirolimus in Renal Transplant Recipients

Zortress is FDA approved, is used as standard of care at some other institutions, and may
also be given as standard of care if it is believed to be the best immunosuppression regimen
for a particular kidney transplant recipient. The rationale for testing Zortress vs.
Rapamune is to determine which of these drugs is more effective in preventing chronic
rejection of the transplanted kidney. Because these two drugs are related to each other
there is no current literature addressing the replacement of Rapamune with Zortress in an
immunosuppression regimen, therefore the goal of this study is to compare these two
immunosuppression drugs.

Inclusion Criteria:

1. Patients must give written informed consent before any assessment is performed.

2. Primary renal transplant recipients between ages 18 and 75 years of age.

3. Females capable of becoming pregnant must have a negative pregnancy test prior to
transplantation and practice an effective form of birth control for the duration of
the study and 12 weeks after discontinuation of the study drug if applicable.

Exclusion Criteria:

1. Total cholesterol > 300 mg/dl or triglycerides > 400 mg/dl despite lipid lowering
therapy

2. Pre-existing bone marrow suppression (White Blood Cell count of < 3000, platelets <
100,000)

3. Active infection (Hepatitis B Virus, HIV)

4. Malignancy (except for adequately treated squamous or basal cell skin carcinoma)
unless patient has written clearance from an Oncologist or if patient has had no
malignancy for at least 2 years prior to the transplant

5. Allergy or intolerance to Zortress, Rapamune, cyclosporine, or Anti-thymocyte
globulin