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
Chong Kun Dang Pharmaceutical
158 participants
Nov 15, 2023
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria4
- 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 Criteria6
- 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
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Interventions
Up to 720mg BID(total 1440mg daily), PO - Check the blood concentration of Mycophenolate at each visit
Up to 1g BID(total 2g daily), PO - Check the blood concentration of Mycophenolate at each visit
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06044493