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

Phase 4

Recruiting

• Conditions: Kidney Transplant
• Interventions: Drug: Mycophenolate mofetil Tablet/Capsule; Drug: Myreptic-N Tablet

• Registration Number: NCT06044493
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief 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

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 Timeline

• Study First Submitted: 2023-08-24
• Study First Submitted QC: 2023-09-13
• Study First Posted: 2023-09-21
• Study Start: 2023-11-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-09
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 158

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Myrept Tablet/Capsule	Mycophenolate mofetil Tablet/Capsule	Mycophenolate mofetil
Myreptic-N Tablet	Myreptic-N Tablet	Mycophenolate sodium

Primary Outcome Measures

Name	Time	Method
Incidence of composite efficacy failure	Until 24 weeks	Composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure

Secondary Outcome Measures

Name	Time	Method
Incidence of Virus infection	Until 24 weeks	Frequency of incidence (BK Virus, CMV)
Incidence of biopsy-confirmed acute rejection	Until 24 weeks	Frequency of incidence
Incidence of Death	Until 24 weeks	Frequency of incidence
Change in survey evaluation score [Gastrointestinal symptom rating scale(GSRS), EuroQol-5D(EQ-5D)]	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.
Incidence of Graft loss	Until 24 weeks	Frequency of incidence
Intra patient variability of mycophenolic acid	Until 24 weeks	Measurement of blood levels of mycophenolic acid
Intra patient variability of calcineurin inhibitor	Until 24 weeks	Measurement of blood levels of calcineurin inhibitor

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of