Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Mycophenolic Acid; Sirolimus

Criteria

Inclusion Criteria:

1. Patients who at least 1 year and less than 10 years after kidney transplatation

2. Over 20 years old

3. Patients on immunosuppressive maintainance therapy using combination of Calcineurin Inhibitor and Mycophenolic acid after kidney transplantation

Exclusion Criteria:

1. Patients who have transplanted organs other than kidney

2. 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)

3. Patents who had a record of taking mTOR inhibitor before 3 months

4. In investigator's judgement