Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

The Effects of Treatment of Subclinical Rejection on Renal Histology and Graft Function in Renal Transplant Patients Receiving Tacrolimus and Mycophenolate Mofetil

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