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OpenTrials
Completed

NCT Number: NCT01842269

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

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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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Maryknoll Medical Center, Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Administration of other Investigational drugs and/or immunosuppressants within 28days before screening period (except allowed immunosuppressants in protocol)
  • Women in pregnant or breast-feeding or don't using adequate contraception.
  • Patient has conversation impairment because alcohol or drugs addiction history within 6months or mental illness, etc.
  • In investigator's judgment

Treatment and study plan

Mycophenolate Mofetil 500mg

Drug

Other names: My-Rept® Tablet

Mycophenolate Mofetil 250mg

Drug

Other names: My-Rept® Capsule

Primary outcomes

  1. Rate of efficacy failure

    Time frame: up to 26 weeks

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

Secondary outcomes

  1. Rate of acute rejection by kidney biopsy

    Time frame: up to 26 weeks

  2. Survival with no graft loss

    Time frame: up to 26 weeks

  3. eGFR(using by MDRD method)

    Time frame: up to 26 weeks

  4. Number of Participants with Adverse Events

    Time frame: up to 26 weeks

    • Rate of adverse events
    • Evaluated safety parameters included: Physical examination, laboratory test, etc.

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Acronym: My-Rept_KT_P4

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 29, 2013
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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