Status:
COMPLETED
Evaluate the Efficacy and Safety of My-Rept® Tablet vs. My-Rept® Capsule in Combination With Tacrolimus in Kidney Transplant Patients
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Kidney Transplantation
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT01842269
Start Date
January 1 2013
End Date
April 1 2015
Last Update
August 19 2015
Active Locations (11)
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1
Maryknoll Medical Center
Busan, South Korea
2
Kyungpook National University Hospital
Daegu, South Korea
3
Yeungnam University Medical Center
Daegu, South Korea
4
Wonkwang University School of Medical & Hospital
Iksan, South Korea