Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients

Inclusion criteria:

- Male or female renal recipients 18-70 years of age undergoing kidney transplantation,
either primary or re-transplant;

- Recipient of a cadaveric, deceased donor (including expanded criteria donor organs
and deceased donor organs after cardiac death), living unrelated or non-HLA identical
living related donor kidney;

- Graft must be functional (producing greater than or equal to 100 ml of urine within
24 hours after transplantation) at time of randomization.

Exclusion criteria:

- Donor organ with a cold ischemic time > 30 hours;

- Males or females who produce less than 100 ml of urine in the first 24 hours
post-transplantation;

- Males or females who are recipients of ABO incompatible transplants, or T cell, or B
cell crossmatch positive transplant;

- Males or females with severe total hypercholesterolemia or total hypertriglyceridemia
(Patients on lipid lowering treatment with controlled hyperlipidemia are acceptable);

- Males or females who have any surgical or any medical condition, such as severe
diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus, which in
the opinion of the investigator, might alter the absorption, distribution, metabolism
and/or excretion of study medication.

Other protocol related inclusion/exclusion criteria may apply.