Overview
The purpose of this study is to evaluate the efficacy and Safety after conversion to RaparoBell® or Myrept® in patients who in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.
Description
This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety after conversion to RaparoBell® or Myrept® administration for 24 weeks in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.
Eligibility
Inclusion Criteria:
- Patients who at least 1 year and less than 10 years after kidney transplantation
- Over 20 years old
- Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolic acid after kidney transplantation
Exclusion Criteria:
- Patients who have transplanted organs other than kidney
- At the time of Screening
- Treatment with active liver disease or Liver function test(T-bilirubin, AST, ALT)is over 3 times than upper normal limit
- WBC< 2,500/mm^3, or platelet < 75,000/mm^3, or ANC < 1,300/ mm^3
- Protein/Creatinine ratio≥1.0(mg/mg)
- Patents who had a record of taking mTOR inhibitor before 3 months
- In investigator's judgement