Status:
RECRUITING
MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Kidney Transplant
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
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
Detailed Description
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 patie...
Eligibility Criteria
Inclusion
- Over 19 years old
- Patients who at least 1 year after kidney transplant
- serum creatinine ≤2.3 mg/dL
- Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolate Mofetil after kidney transplantation
Exclusion
- Patients who had received treatment Acute rejection within 4 weeks
- Patients who had discontinued corticosteroid within 4 weeks
- 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
- In investigator's judgement
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT06044493
Start Date
November 15 2023
End Date
November 1 2025
Last Update
December 16 2024
Active Locations (1)
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1
Seoul National University Hospital
Seoul, Seoul, South Korea, 03080