Kidney Transplantation
Conditions
Keywords
Mycophenolate Mofetil, MMF
Brief summary
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
Interventions
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 20 years or older. 2. Patient who receive primary or secondary kidney transplantation from living or brain-dead donor . 3. Patient who receive age 20 years or older donor. 4. Willing and able to provide written informed consent.
Exclusion criteria
1. Cold Ischemia Time \> 30 hours. 2. Patient who receive HLA-identical donor. 3. Patient with dual kidney transplantation recipient or have history of other organ transplantation in past or current. 4. Patient who receive extra-renal solid organ or bone marrow stem cell transplantation. 5. Patient who receive kidney transplantation from non-heart beating cadaveric donor(organ donor after cardiac death 6. Patient who receive kidney transplantation from ABO blood type mismatching donor or lymphocyte cross matching (LCM) positive donor. 7. Patient with cancer within 5 years, except cured skin cancer patient(Squamous cell or basal cell carcinoma) 8. Positive in serology test(HIV, HBsAg, HCV) in recipients and/or donor. 9. Patient with Severe gastrointestinal disease in screening period by investigator's decision. 10. Patient with systemic severe infection requiring treatment (able to transplantation after completely disappear or is controlled infection) 11. Liver cirrhosis, clinically significant portal hypertension or other moderate to severe liver disease. 12. Defined by the following laboratory parameters before screening period 1. One of liver function test(AST, ALT, ALP, Total Bilirubin)results increased more than 3 times upper limit of normal range 2. WBC \<2,500/mm3, Platelet \<75,000/mm3 13. 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. 14. Administration of other Investigational drugs and/or immunosuppressants within 28days before screening period (except allowed immunosuppressants in protocol) 15. Women in pregnant or breast-feeding or don't using adequate contraception. 16. Patient has conversation impairment because alcohol or drugs addiction history within 6months or mental illness, etc. 17. In investigator's judgment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of efficacy failure | up to 26 weeks | efficacy failure=acute rejection by kidney biopsy,graft loss, death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | up to 26 weeks | * Rate of adverse events * Evaluated safety parameters included: Physical examination, laboratory test, etc. |
Countries
South Korea
Outcome results
None listed