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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Kidney Transplant

Intervention / Treatment
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* Drug: Myreptic-N Tablet
* Drug: Mycophenolate mofetil Tablet/Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myreptic-N Tablet<br>Mycophenolate sodium | Drug: Myreptic-N Tablet<br>* Up to 720mg BID(total 1440mg daily), PO - Check the blood concentration of Mycophenolate at each visit<br>* Other names: Myreptic-N®;|
| Active Comparator: Myrept Tablet/Capsule<br>Mycophenolate mofetil | Drug: Mycophenolate mofetil Tablet/Capsule<br>* Up to 1g BID(total 2g daily), PO - Check the blood concentration of Mycophenolate at each visit<br>* Other names: Myrept® Cap./Tab.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of composite efficacy failure | Composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure | Until 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in survey evaluation score [Gastrointestinal symptom rating scale(GSRS), EuroQol-5D(EQ-5D)] | The GSRS consists of 15 questions, with a total score of 15 to 105, indicating that the higher the total score, the more severe the gastrointestinal symptoms. The EQ-5D evaluates quality of life and consists of 5 questions. Each question is evaluated in the range of 1 to 5. The score is calculated according to EQ-5D index. Calculated score is lower that means poor health. | Changes in scores from the baseline at week 24 | 
| Intra patient variability of mycophenolic acid | Measurement of blood levels of mycophenolic acid | Until 24 weeks | 
| Intra patient variability of calcineurin inhibitor | Measurement of blood levels of calcineurin inhibitor | Until 24 weeks | 
| Incidence of Virus infection | Frequency of incidence (BK Virus, CMV) | Until 24 weeks | 
| Incidence of biopsy-confirmed acute rejection | Frequency of incidence | Until 24 weeks | 
| Incidence of Graft loss | Frequency of incidence | Until 24 weeks | 
| Incidence of Death | Frequency of incidence | Until 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney transplant, Mycophenolic acid