Kidney TransplantPhase 4MyMyNCT06044493
MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients
A Phase 4 study testing Myreptic-N Tablet and Mycophenolate mofetil Tablet/Capsule in people with Kidney Transplant, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- Myreptic-N Tablet and Mycophenolate mofetil Tablet/Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Nov 2023to 29 Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
Read the 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.
- Conditions
- Kidney Transplant
- Being tested
- Myreptic-N Tablet, Mycophenolate mofetil Tablet/Capsule
- Keywords
- Kidney transplant, Mycophenolic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myreptic-N TabletDrug
Also called Myreptic-N®
Up to 720mg BID(total 1440mg daily), PO - Check the blood concentration of Mycophenolate at each visit
Mycophenolate mofetil Tablet/CapsuleDrug
Also called Myrept® Cap./Tab.
Up to 1g BID(total 2g daily), PO - Check the blood concentration of Mycophenolate at each visit
| Study group | Role | What they receive |
|---|---|---|
| Myreptic-N Tablet | Experimental | Mycophenolate sodium Receives: Drug: Myreptic-N Tablet |
| Myrept Tablet/Capsule | Active comparator | Mycophenolate mofetil Receives: Drug: Mycophenolate mofetil Tablet/Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of composite efficacy failure
Composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure
Measured: Until 24 weeks
Secondary outcomes (7)
Change in survey evaluation score [Gastrointestinal symptom rating scale(GSRS), EuroQol-5D(EQ-5D)]
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.
Measured: Changes in scores from the baseline at week 24
Intra patient variability of mycophenolic acid
Measurement of blood levels of mycophenolic acid
Measured: Until 24 weeks
Intra patient variability of calcineurin inhibitor
Measurement of blood levels of calcineurin inhibitor
Measured: Until 24 weeks
Incidence of Virus infection
Frequency of incidence (BK Virus, CMV)
Measured: Until 24 weeks
Incidence of biopsy-confirmed acute rejection
Frequency of incidence
Measured: Until 24 weeks
Incidence of Graft loss
Frequency of incidence
Measured: Until 24 weeks
Incidence of Death
Frequency of incidence
Measured: Until 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start14 Nov 2023
- Primary completion29 Oct 2025
- Study completion29 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jongwon Ha, MD, PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044493
- Sponsor's protocol ID
- B130_01KT2203
- Acronym
- MyMy
- Status last verified
- Apr 2026
- First submitted
- 24 Aug 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06044493
- Acronym / sponsor ID
- MyMy / B130_01KT2203
- Conditions
- Kidney Transplant
- Keywords
- Kidney transplant, Mycophenolic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 29 Oct 2025 (actual)
- Study completion
- 29 Oct 2025 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myreptic-N Tablet | Experimental | Drug: Myreptic-N TabletMycophenolate sodium |
| Myrept Tablet/Capsule | Active comparator | Drug: Mycophenolate mofetil Tablet/CapsuleMycophenolate mofetil |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Patients who had received treatment Acute rejection within 4 weeks
- Patients who had discontinued corticosteroid within 4 weeks
- At the time of Screening
- In investigator's judgement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myreptic-N TabletAlso: Myreptic-N®Up to 720mg BID(total 1440mg daily), PO - Check the blood concentration of Mycophenolate at each visit | Drug | Myreptic-N Tablet |
| Mycophenolate mofetil Tablet/CapsuleAlso: Myrept® Cap./Tab.Up to 1g BID(total 2g daily), PO - Check the blood concentration of Mycophenolate at each visit | Drug | Myrept Tablet/Capsule |
Primary outcome
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
7 secondary outcomes
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
Intra patient variability of mycophenolic acid
Time frame: Until 24 weeks
Intra patient variability of calcineurin inhibitor
Time frame: Until 24 weeks
Incidence of Virus infection
Time frame: Until 24 weeks
Incidence of biopsy-confirmed acute rejection
Time frame: Until 24 weeks
Incidence of Graft loss
Time frame: Until 24 weeks
Incidence of Death
Time frame: Until 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
Related trials for Kidney Transplant
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jongwon Ha, MD, PhD study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Myreptic-N Tablet and Mycophenolate mofetil Tablet/Capsule in people with Kidney Transplant, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of composite efficacy failure (time frame: Until 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.