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

Sponsor
Chong Kun Dang Pharmaceutical (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06044493
Collaborator
(none)
158
Enrollment
2
Arms
25.6
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Myreptic-N Tablet
  • Drug: Mycophenolate mofetil Tablet/Capsule
 Phase 4

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

Study Type:
Interventional
Anticipated Enrollment :
158 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Sep 13, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

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.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. Intra patient variability of mycophenolic acid [Until 24 weeks]

      Measurement of blood levels of mycophenolic acid

    3. Intra patient variability of calcineurin inhibitor [Until 24 weeks]

      Measurement of blood levels of calcineurin inhibitor

    4. Incidence of Virus infection [Until 24 weeks]

      Frequency of incidence (BK Virus, CMV)

    5. Incidence of biopsy-confirmed acute rejection [Until 24 weeks]

      Frequency of incidence

    6. Incidence of Graft loss [Until 24 weeks]

      Frequency of incidence

    7. Incidence of Death [Until 24 weeks]

      Frequency of incidence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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/mm3, or platelet < 75,000/mm3, or ANC < 1,300/ mm^3

    1. In investigator's judgement

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Chong Kun Dang Pharmaceutical

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chong Kun Dang Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT06044493
    Other Study ID Numbers:
    • B130_01KT2203
    First Posted:
    Sep 21, 2023
    Last Update Posted:
    Sep 21, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chong Kun Dang Pharmaceutical
    Kidney transplant
    Mycophenolic acid
    Additional relevant MeSH terms:
    Mycophenolic Acid

    Study Results

    No Results Posted as of Sep 21, 2023