A Study to Assess the Efficacy and Safety of Advagraf® Switching From Cyclosporine Between the Group That Was Treated With a 50% Reduced Corticosteroid and the Group With Maintained Corticosteroid for Stable Kidney Transplant Recipients

The primary objective is to assess the changes in the GFR after 24 weeks of treatment between the group that was reduced corticosteroid slowly until 50% lower dose from 4 weeks to 12 weeks and the group with maintained corticosteroid in stable kidney transplant subjects whose regimen was converted from a CyA-based immunosuppressive regimen with corticosteroid to an Advagraf®-based immunosuppressive regimen with corticosteroid for kidney transplant subjects whose regimen was converted from a CyA-based immunosuppressive regimen.

The secondary objective is to assess the creatinine clearance rate, acute rejection, satisfaction of medication and safety of the group with a 50% reduced dose of corticosteroid and the group in which the Advagraf ®-based immunosuppressive regimen with maintained corticosteroid.

Inclusion criteria

• Had a kidney transplant at least 12 months before his/her enrollment in this study (including a kidney retransplantation).
• Underwent a CyA-based immunosuppressive regimen since his/her last transplantation. The CyA dose remained unchanged during the last four weeks before the subject's enrollment.
• The immunosuppressive regimen (combination of medications) remained unchanged for a minimum of four weeks before the subject's enrollment.
• GFR≥30 mL/min

Exclusion criteria

• Had received an organ transplant other than a kidney
• Had an acute rejection episode within 12 weeks before his/her enrollment in this study, or had an acute rejection episode within 24 weeks before his/her enrollment in this study that required anti-lymphocyte antibody therapy
• Had been diagnosed with new-onset malignancy after his/her transplantation, except for basocellular or squamous cell carcinoma of the skin that had been treated successfully
• The subject received a kidney transplant from full-HLA identical donor
• Known to have FSGS or MPGN Type II as an underlying disease
• Has elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigated site
• Has liver cirrhosis