MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients

A Multicenter, Randomization, Open-label Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients

The purpose of this study is to Evaluate the Efficacy and Safety of MYREPTIC-N® or MY-REPT® in Stable Patients after Kidney Transplant Recipients

This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety of MYREPTIC-N® or MY-REPT® administration for 24 weeks in renal transplant patients combined Calcineurin inhibitor.

Inclusion Criteria:

1. Over 19 years old
2. Patients who at least 1 year after kidney transplant
3. serum creatinine ≤2.3 mg/dL
4. Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolate Mofetil after kidney transplantation

Exclusion Criteria:

1. Patients who had received treatment Acute rejection within 4 weeks

2. Patients who had discontinued corticosteroid within 4 weeks

3. 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

4. In investigator's judgement