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

Phase 4

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: Mycophenolate Mofetil 250mg; Drug: Mycophenolate Mofetil 500mg

• Registration Number: NCT01842269
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-04-25
• Study First Submitted QC: 2013-04-25
• Study First Posted: 2013-04-29
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
My-Rept® Capsule	Mycophenolate Mofetil 250mg	My-Rept® Capsule, Mycophenolate Mofetil 250mg, orally
My-Rept® Tablet	Mycophenolate Mofetil 500mg	My-Rept® Tablet, Mycophenolate Mofetil 500mg, orally

Primary Outcome Measures

Name	Time	Method
Rate of efficacy failure	up to 26 weeks	efficacy failure=acute rejection by kidney biopsy,graft loss, death

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (11)

Kandong Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of

Chunbuk National University Hospital; 🇰🇷 Chonju, Korea, Republic of

Wonkwang University School of Medical & Hospital; 🇰🇷 Iksan, Korea, Republic of

Bundang CHA Medical Center; 🇰🇷 Seongnam, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwan, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of

Maryknoll Medical Center; 🇰🇷 Busan, Korea, Republic of

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of