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

April 10, 2026 updated by: Chong Kun Dang Pharmaceutical

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients who had received treatment Acute rejection within 4 weeks
  2. Patients who had discontinued corticosteroid within 4 weeks

  3. 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
  4. In investigator's judgement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Myreptic-N Tablet
Mycophenolate sodium
Drug: Myreptic-N Tablet
Up to 720mg BID(total 1440mg daily), PO - Check the blood concentration of Mycophenolate at each visit
Other Names:
  • Myreptic-N®
Active Comparator: Myrept Tablet/Capsule
Mycophenolate mofetil
Drug: Mycophenolate mofetil Tablet/Capsule
Up to 1g BID(total 2g daily), PO - Check the blood concentration of Mycophenolate at each visit
Other Names:
  • Myrept® Cap./Tab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Changes in scores from the baseline at week 24
Intra patient variability of mycophenolic acid
Time Frame: Until 24 weeks
Measurement of blood levels of mycophenolic acid
Until 24 weeks
Intra patient variability of calcineurin inhibitor
Time Frame: Until 24 weeks
Measurement of blood levels of calcineurin inhibitor
Until 24 weeks
Incidence of Virus infection
Time Frame: Until 24 weeks
Frequency of incidence (BK Virus, CMV)
Until 24 weeks
Incidence of biopsy-confirmed acute rejection
Time Frame: Until 24 weeks
Frequency of incidence
Until 24 weeks
Incidence of Graft loss
Time Frame: Until 24 weeks
Frequency of incidence
Until 24 weeks
Incidence of Death
Time Frame: Until 24 weeks
Frequency of incidence
Until 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

  • Study Chair: Jongwon Ha, MD, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2023

Primary Completion (Actual)

October 29, 2025

Study Completion (Actual)

October 29, 2025

Study Registration Dates

First Submitted

August 24, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B130_01KT2203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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