Asian Study to Investigate Safety and Efficacy of Optimized Dosing of Advagraf in Kidney Transplantation

A Multi-center, Randomized, Open-label, Pilot and Exploratory Study Investigating Safety and Efficacy in OPTIMIZEd Dosing of Advagraf® Kidney Transplantation in Asia.

Primary purpose of this study is to compare renal function between subjects receiving optimized dose Advagraf® over 52 weeks after kidney transplantation and subjects receiving standard dose Advagraf®. Pilot results of safety and efficacy in optimized dose Advagraf® over 52 weeks after kidney transplantation will also be obtained.

Inclusion Criteria:

• End stage kidney disease and a suitable candidate for primary kidney transplantation or re-transplantation
• Receiving a kidney transplant from a deceased or living donor with compatible ABO blood type
• Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study. And, male subject of childbearing potential should agree to maintain effective birth control during the study

Exclusion Criteria:

• Receiving or having previously received an organ transplant other than a kidney
• Cold ischemia time of the donor kidney > 24 hours
• Receiving a graft from a non-heart-beating donor other than of Maastricht category 3
• Significant liver disease
• Receiving a graft from a hepatitis C or B positive donor
• Requiring on-going dosing with a systemic immunosuppressive drug prior to transplantation (e.g. for Lupus disease, FSGN etc) other than minimal levels of immunosuppressant following failure of a previous transplantation without nephrectomy
• Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract mal absorption or active peptic ulcer
• Subject or donor known to be HIV positive
• Known allergy or intolerance to tacrolimus, macrolide antibiotics, steroids, lactose, basiliximab or MMF or any of the product excipient
• Subject has malignant tumor
• Currently participating in another clinical trial, and/or has taken an investigational drug within 12 weeks prior to the study
• Subject with a high immunological risk