Clinical trial NCT01842269: Evaluate the Efficacy and Safety of My-Rept® Tablet vs. My-Rept® Capsule in Combination With Tacrolimus in Kidney Transplant Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: Mycophenolate Mofetil
MMF
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2013-04-29
Enrollment: 156
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Rate of efficacy failure
timeFrame: up to 26 weeks
Secondary outcomes:
measure: Rate of acute rejection by kidney biopsy
timeFrame: up to 26 weeks
measure: Survival with no graft loss
timeFrame: up to 26 weeks
measure: eGFR(using by MDRD method)
timeFrame: up to 26 weeks
measure: Number of Participants with Adverse Events
timeFrame: up to 26 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Maryknoll Medical Center
city: Chonju
country: Korea, Republic of
facility: Chunbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Iksan
country: Korea, Republic of
facility: Wonkwang University School of Medical & Hospital
city: Seongnam
country: Korea, Republic of
facility: Bundang CHA Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Kandong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Suwan
country: Korea, Republic of
facility: Ajou University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Severance Hospital
name: Yu Seun Kim, Ph. D
role: PRINCIPAL_INVESTIGATOR
References: