Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients

This study will compare the efficacy and safety of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil in Kidney Transplant Patients.

Inclusion Criteria:

• Male or female patients aged over 20 years
• Patient who is judged would have the benefits of the Extended Release Tacrolimus (Advagraf®)treatment by the investigator
• Patients has given written informed consent
• Patient is a recipient of primary or recipient of primary (a living kidney transplant, a cadaveric donor.)
• Patients has received an ABO compatible donor kidney.
• Complement-dependent Cytotoxic Crossmatch: CDC) result: negative
• Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment or upon hospitalization

Exclusion Criteria:

• Patient has previously received an organ transplant other than a kidney.
• Patient has a known hypersensitivity to tacrolimus, Sirolimus (Rapamune®),Mycophenolate mofetil.
• Desensitization
• HLA-identical
• Heart Disease; Heart failure (symptom, EF <45%)
• Lung Disease; Significant chronic obstructive pulmonary disease, restrictive lung disease
• Patient has an uncontrolled concomitant infection (including Hepatitis B, Hepatitis C) or any other unstable
• malignant tumor history in the 5years prior to enrollment. (except,squamous cell carcinoma)
• Patient has received a kidney transplant from non-heart beating donor
• Cold ischemic time > 30hrs
• Elevated AST and/or ALT levels greater than 3 times the upper value of the normal range of the investigational site
• (ANC)<1,500/mm3, (WBC)<2,500/ mm3, (PLT)<100,000/ mm3
• ATG: Anti-thymocyte globulin induction
• Medical condition that could interfere with the study objectives.
• Patient is currently taking or has been taking an investigational products in the 30 days prior to enrollment.
• Patient is currently taking or has been taking an prohibited medications in the 28 days prior to enrollment.
• Patient who is judged not to be adequate by the investigator owing to other reasons
• Patient is pregnant or lactating.
• Recipient or donor is known to be seropositive for human immunodeficiency virus.(HIV)