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Efficacy and Safety of My-ReptĀ® Tablet(Mycophenolate Mofetil 500mg/Tab.) versus My-ReptĀ® Capsule(Mycophenolate Mofetil 250mg/Cap.) in Combination with Tacrolimus in Kidney Transplant Patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| My-ReptĀ® Tablet | Experimental | My-ReptĀ® Tablet, Mycophenolate Mofetil 500mg, orally |
|
| My-ReptĀ® Capsule | Active Comparator | My-ReptĀ® Capsule, Mycophenolate Mofetil 250mg, orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolate Mofetil 500mg | Drug |
|
| |
| Mycophenolate Mofetil 250mg |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of efficacy failure | efficacy failure=acute rejection by kidney biopsy,graft loss, death | up to 26 weeks |
| 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) |
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Inclusion Criteria:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Yu Seun Kim, Ph. D | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maryknoll Medical Center | Busan | South Korea | ||||
| Kyungpook National University Hospital |
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| Drug |
|
|
| up to 26 weeks |
| Number of Participants with Adverse Events |
| up to 26 weeks |
| Daegu |
| South Korea |
| Yeungnam University Medical Center | Daegu | South Korea |
| Wonkwang University School of Medical & Hospital | Iksan | South Korea |
| Chunbuk National University Hospital | Jeonju | South Korea |
| Bundang CHA Medical Center | Seongnam | South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Kandong Sacred Heart Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| Ajou University Hospital | Suwan | South Korea |
| Ulsan University Hospital | Ulsan | South Korea |
| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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