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

NCT01842269 | Completed Phase 4

• 1 other identifier: 223KTP12003
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 11

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

Conditions

Kidney Transplantation

Keywords

Mycophenolate Mofetil; MMF

Outcome Measures

Primary Outcomes (1)

• Rate of efficacy failure

  efficacy failure=acute rejection by kidney biopsy,graft loss, death

  up to 26 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

My-Rept® Tablet

EXPERIMENTAL

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

Drug: Mycophenolate Mofetil 500mg

My-Rept® Capsule

ACTIVE COMPARATOR

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

Drug: Mycophenolate Mofetil 250mg

Interventions

Mycophenolate Mofetil 500mg DRUG

Also known as: My-Rept® Tablet

My-Rept® Tablet

Mycophenolate Mofetil 250mg DRUG

Also known as: My-Rept® Capsule

My-Rept® Capsule

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20 years or older.
• Patient who receive primary or secondary kidney transplantation from living or brain-dead donor .
• Patient who receive age 20 years or older donor.
• Willing and able to provide written informed consent.

You may not qualify if:

• Cold Ischemia Time \> 30 hours.
• Patient who receive HLA-identical donor.
• Patient with dual kidney transplantation recipient or have history of other organ transplantation in past or current.
• Patient who receive extra-renal solid organ or bone marrow stem cell transplantation.
• Patient who receive kidney transplantation from non-heart beating cadaveric donor(organ donor after cardiac death
• Patient who receive kidney transplantation from ABO blood type mismatching donor or lymphocyte cross matching (LCM) positive donor.
• Patient with cancer within 5 years, except cured skin cancer patient(Squamous cell or basal cell carcinoma)
• Positive in serology test(HIV, HBsAg, HCV) in recipients and/or donor.
• Patient with Severe gastrointestinal disease in screening period by investigator's decision.
• Patient with systemic severe infection requiring treatment (able to transplantation after completely disappear or is controlled infection)
• Liver cirrhosis, clinically significant portal hypertension or other moderate to severe liver disease.
• Defined by the following laboratory parameters before screening period
• One of liver function test(AST, ALT, ALP, Total Bilirubin)results increased more than 3 times upper limit of normal range
• WBC \<2,500/mm3, Platelet \<75,000/mm3
• 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.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (11)

Maryknoll Medical Center

Busan, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Wonkwang University School of Medical & Hospital

Iksan, South Korea

Location

Chunbuk National University Hospital

Jeonju, South Korea

Location

Bundang CHA Medical Center

Seongnam, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Kandong Sacred Heart Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Ajou University Hospital

Suwan, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Yu Seun Kim, Ph. D

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2013
• First Posted: April 29, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 19, 2015

Record last verified: 2015-08

Locations

KR (11)