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

Kidney Transplantation Clinical Trial

— My-Rept_KT_P4  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842269
• Other study ID #: 223KTP12003
• Status: Completed
• Phase: Phase 4
• First received: April 25, 2013
• Last updated: August 18, 2015
• Start date: January 2013
• Est. completion date: April 2015

Study information

• Verified date: August 2015
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Mycophenolate Mofetil 500mg

• Mycophenolate Mofetil 250mg

Locations

Country	Name	City	State
Korea, Republic of	Maryknoll Medical Center	Busan
Korea, Republic of	Chunbuk National University Hospital	Chonju
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Wonkwang University School of Medical & Hospital	Iksan
Korea, Republic of	Bundang CHA Medical Center	Seongnam
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Kandong Sacred Heart Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwan
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of efficacy failure	efficacy failure=acute rejection by kidney biopsy,graft loss, death	up to 26 weeks	No
Secondary	Rate of acute rejection by kidney biopsy		up to 26 weeks	No
Secondary	Survival with no graft loss		up to 26 weeks	No
Secondary	eGFR(using by MDRD method)		up to 26 weeks	No
Secondary	Number of Participants with Adverse Events	Rate of adverse events; Evaluated safety parameters included: Physical examination, laboratory test, etc.	up to 26 weeks	Yes