Evaluate the Efficacy and Safety of My-Rept® Tablet vs. My-Rept® Capsule in Combination With Tacrolimus in Kidney Transplant Patients

Study Overview
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Brief Summary
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Efficacy and Safety of My-Rept® Tablet(Mycophenolate Mofetil 500mg/Tab.) versus My-Rept® Capsule(Mycophenolate Mofetil 250mg/Cap.) in Combination with Tacrolimus in Kidney Transplant Patients

Official Title
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Open Label, Randomized, Multi-center, Phase 4 Trial to Evaluate the Efficacy and Safety of My-Rept® Tablet(Mycophenolate Mofetil 500mg/Tab.) Versus My-Rept® Capsule(Mycophenolate Mofetil 250mg/Cap.) in Combination With Tacrolimus for 26 Weeks in Kidney Transplant Patients

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: Mycophenolate Mofetil 500mg
* Drug: Mycophenolate Mofetil 250mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20 years or older. Patient who receive primary or secondary kidney transplantation from living or brain-dead donor . Patient who receive age 20 years or older donor. Willing and able to provide written informed consent. Exclusion Criteria: Cold Ischemia Time > 30 hours. Patient who receive HLA-identical donor. Patient with dual kidney transplantation recipient or have history of other organ transplantation in past or current. Patient who receive extra-renal solid organ or bone marrow stem cell transplantation. Patient who receive kidney transplantation from non-heart beating cadaveric donor(organ donor after cardiac death Patient who receive kidney transplantation from ABO blood type mismatching donor or lymphocyte cross matching (LCM) positive donor. Patient with cancer within 5 years, except cured skin cancer patient(Squamous cell or basal cell carcinoma) Positive in serology test(HIV, HBsAg, HCV) in recipients and/or donor. Patient with Severe gastrointestinal disease in screening period by investigator's decision. Patient with systemic severe infection requiring treatment (able to transplantation after completely disappear or is controlled infection) Liver cirrhosis, clinically significant portal hypertension or other moderate to severe liver disease. Defined by the following laboratory parameters before screening period One of liver function test(AST, ALT, ALP, Total Bilirubin)results increased more than 3 times upper limit of normal range WBC <2,500/mm3, Platelet <75,000/mm3 Acute (within 4 weeks) or chronic(need to treatments) allergic/hypersensitivity reaction in the history of Investigational drugs (ex, mycophenolate acid or tacrolimus, etc.) or additives. Administration of other Investigational drugs and/or immunosuppressants within 28days before screening period (except allowed immunosuppressants in protocol) Women in pregnant or breast-feeding or don't using adequate contraception. Patient has conversation impairment because alcohol or drugs addiction history within 6months or mental illness, etc. In investigator's judgment

Ages Eligible for Study
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Minimum Age: 20 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: My-Rept® Tablet<br>My-Rept® Tablet, Mycophenolate Mofetil 500mg, orally | Drug: Mycophenolate Mofetil 500mg<br> <br> * Other names: My-Rept® Tablet;|
| Active Comparator: My-Rept® Capsule<br>My-Rept® Capsule, Mycophenolate Mofetil 250mg, orally | Drug: Mycophenolate Mofetil 250mg<br> <br> * Other names: My-Rept® Capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of efficacy failure | efficacy failure=acute rejection by kidney biopsy,graft loss, death | up to 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of acute rejection by kidney biopsy |  | up to 26 weeks | 
| Survival with no graft loss |  | up to 26 weeks | 
| eGFR(using by MDRD method) |  | up to 26 weeks | 
| Number of Participants with Adverse Events | Rate of adverse events Evaluated safety parameters included: Physical examination, laboratory test, etc. | up to 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mycophenolate Mofetil, MMF