Advagraf/Prograf Conversion Trial (SG#153)

Inclusion Criteria:

• Renal transplant or Renal Pancreas patients who are > 12 months post transplant
• Stable allograft function defined as eGFR > 30-60ml/min
• Renal patients who have a stable tacrolimus trough level of 5-8ng/ml in prior 3 months; Renal pancreas patients who have a stable tacrolimus trough level of 3-10 mg/ml in prior 3 months
• Receiving concomitant therapy with mycophenolate mofetil in a dose of 500-1000mg bid or equivalent

Exclusion Criteria:

• Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
• History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
• Treated rejection within 3 months of randomization.
• Increased serum creatinine > 20% within 3 months of randomization.
• Subject is pregnant or breastfeeding
• Subject has significant co-morbid disease (eg. Malignancy or uncontrolled infection) or disability (e.g. cognitive deficit) which prevents understanding of, or adherence to, the protocol