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Completed

NCT Number: NCT06044493

MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients

The purpose of this study is to Evaluate the Efficacy and Safety of MYREPTIC-N® or MY-REPT® in Stable Patients after Kidney Transplant Recipients

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Key information

Conditions

Kidney Transplant

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety of MYREPTIC-N® or MY-REPT® administration for 24 weeks in renal transplant patients combined Calcineurin inhibitor.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Over 19 years old
  • Patients who at least 1 year after kidney transplant
  • serum creatinine ≤2.3 mg/dL
  • Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolate Mofetil after kidney transplantation

Exclusion criteria

  • Patients who had received treatment Acute rejection within 4 weeks
  • Patients who had discontinued corticosteroid within 4 weeks
  • At the time of Screening
  • Treatment with active liver disease or Liver function test(T-bilirubin, AST, ALT)is over 3 times than upper normal limit
  • WBC< 2,500/mm^3, or platelet < 75,000/mm^3, or ANC < 1,300/ mm^3
  • In investigator's judgement

Treatment and study plan

Myreptic-N Tablet

Drug

Up to 720mg BID(total 1440mg daily), PO - Check the blood concentration of Mycophenolate at each visit

Other names: Myreptic-N®

Mycophenolate mofetil Tablet/Capsule

Drug

Up to 1g BID(total 2g daily), PO - Check the blood concentration of Mycophenolate at each visit

Other names: Myrept® Cap./Tab.

Primary outcomes

  1. Incidence of composite efficacy failure

    Time frame: Until 24 weeks

    Composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure

Secondary outcomes

  1. Change in survey evaluation score [Gastrointestinal symptom rating scale(GSRS), EuroQol-5D(EQ-5D)]

    Time frame: Changes in scores from the baseline at week 24

    The GSRS consists of 15 questions, with a total score of 15 to 105, indicating that the higher the total score, the more severe the gastrointestinal symptoms.

    The EQ-5D evaluates quality of life and consists of 5 questions. Each question is evaluated in the range of 1 to 5. The score is calculated according to EQ-5D index. Calculated score is lower that means poor health.

  2. Intra patient variability of mycophenolic acid

    Time frame: Until 24 weeks

    Measurement of blood levels of mycophenolic acid

  3. Intra patient variability of calcineurin inhibitor

    Time frame: Until 24 weeks

    Measurement of blood levels of calcineurin inhibitor

  4. Incidence of Virus infection

    Time frame: Until 24 weeks

    Frequency of incidence (BK Virus, CMV)

  5. Incidence of biopsy-confirmed acute rejection

    Time frame: Until 24 weeks

    Frequency of incidence

  6. Incidence of Graft loss

    Time frame: Until 24 weeks

    Frequency of incidence

  7. Incidence of Death

    Time frame: Until 24 weeks

    Frequency of incidence

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

A Multicenter, Randomization, Open-label Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients

Acronym: MyMy

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2023
Registry last updated
Apr 15, 2026

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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