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.

• Drug: A) TEST

  1. Extended Release Tacrolimus (Advagraf®)

     ① Living The day before surgery: 0.2 mg/kg(morning dose) po, qd Morning on the day of surgery: 0.1 mg/kg po, qd After surgery, the capacity is adjusted according to the trough level. clinical significance, electrolyte level.

     ② Cadaveric Before surgery at once : 0.1 mg/kg within 12hours before surgery. After surgery : 0.2mg/kg po. in the morning After that, the capacity is adjusted according to the trough level. clinical significance, electrolyte level.

  2. Sirolimus (Rapamune®):

  After surgery : 2mg/kg po. within 24hrs after reperfusion. After that, the capacity is adjusted according to the trough level.

  Other Name: 1. Test group : Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®)
• Drug: B) CONTROL

  1. Extended Release Tacrolimus (Advagraf®)

     : Same as above.

  2. Mycophenolate mofetil : After surgery : 500mg/kg po. within 24hrs after reperfusion. After that, daily dose: 1000mg bid
  Other Name: 2. Control group: Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil

• Active Comparator: A) TEST
  Interventions:

  • Drug: A) TEST
  • Drug: B) CONTROL
• Experimental: B) CONTROL
  Interventions:

  • Drug: A) TEST
  • Drug: B) CONTROL

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)