Evaluate the Efficacy and Safety of My-Rept® Tablet vs. My-Rept® Capsule in Combination With Tacrolimus in Kidney Transplant Patients (My-Rept_KT_P4)

Chong Kun Dang

Status and phase: Completed; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: Mycophenolate Mofetil 250mg; Drug: Mycophenolate Mofetil 500mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01842269

223KTP12003

Details and patient eligibility

About

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

Enrollment: 156 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

My-Rept® Tablet

Experimental group

Description:

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

Treatment:

Drug: Mycophenolate Mofetil 500mg

My-Rept® Capsule

Active Comparator group

Description:

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

Treatment:

Drug: Mycophenolate Mofetil 250mg