Status:
UNKNOWN
Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Kidney Transplantation
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief 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 Mycophenoli...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT05193565
Start Date
November 19 2021
End Date
June 1 2024
Last Update
February 1 2022
Active Locations (1)
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1
The Catholic University of Korea, Seoul, St.Mary's Hospital
Seoul, South Korea