This multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection versus a non-protocol biopsy control group.

Inclusion Criteria:

• Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant
• If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods

Exclusion Criteria:

• Recipients of a kidney from a donor over 65 years of age
• Recipient of non-related donor kidney with peak pre-transplant PRA > 50
• Subject has lost a previous graft to rejection less than one year from transplant
• Subject who has received an investigational drug within three months prior to randomization
• Subjects who are pregnant or breastfeeding
• Subject receives a kidney lacking a pre-implantation biopsy
• Subject has significant disease or disability (e.g. malignancy or uncontrolled infection) which prevents adherence to the protocol