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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-04-30

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

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Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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My-Rept® Tablet

My-Rept® Tablet, Mycophenolate Mofetil 500mg, orally

Group Type EXPERIMENTAL

Mycophenolate Mofetil 500mg

Intervention Type DRUG

My-Rept® Capsule

My-Rept® Capsule, Mycophenolate Mofetil 250mg, orally

Group Type ACTIVE_COMPARATOR

Mycophenolate Mofetil 250mg

Intervention Type DRUG

Interventions

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Mycophenolate Mofetil 500mg

Intervention Type DRUG

Mycophenolate Mofetil 250mg

Intervention Type DRUG

Other Intervention Names

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My-Rept® Tablet My-Rept® Capsule

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No