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Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients

Sponsor
Chong Kun Dang Pharmaceutical (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05193565
Collaborator
(none)
206
Enrollment
1
Location
2
Arms
30.4
Anticipated Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and Safety after conversion to RaparoBell® or Myrept® in patients who in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety after conversion to RaparoBell® or Myrept® administration for 24 weeks in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
206 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multi-center, Open-label, Randomized Controlled Phase 4 Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients Undergoing Maintenance Therapy With CNI Plus MPA.[CORAL Study]
Actual Study Start Date :
Nov 19, 2021
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: RaparoBell Tablet

RaparoBell Tablet

Drug: Sirolimus
Orally, once-daily in the morning - Check the blood concentration of Sirolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3~8ng/mL
Other Names:
  • RaparoBell® Tab.

    		•
    Active Comparator: Mycophenolate Mofetil Tablet/Capsule

    Myrept Tablet/Capsule

    Drug: Mycophenolate mofetil
    Up to 1g BID(total 2g daily), PO
    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. Incidence of biopsy-confirmed acute rejection(TCMR, AMR) [Until 24 weeks]

      The frequency and Incidence

    2. Pathologic Results, Occurrence, Treatment Methods, and Results of Acute Rejection Confirmed by Biopsy [Until 24 weeks]

      By Banff classification categories

    3. Survival rate of transplanted organ [Until 24 weeks]

      Kaplan-Meier

    4. Survival rate of Patients [Until 24 weeks]

      Kaplan-Meier

    5. Serum-Cr, eGFR [Until 24 weeks]

      eGFR using MDRD

    6. Incidence of BKV, CMV infection [Until 24 weeks]

      The frequency and Incidence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients who at least 1 year and less than 10 years after kidney transplantation

    2. Over 20 years old

    3. Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolic acid after kidney transplantation

    Exclusion Criteria:

    1. Patients who have transplanted organs other than kidney

    2. 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

    • Protein/Creatinine ratio≥1.0(mg/mg)

    1. Patents who had a record of taking mTOR inhibitor before 3 months

    2. In investigator's judgement

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Catholic University of Korea, Seoul, St.Mary's Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Chong Kun Dang Pharmaceutical

    Investigators

    • Study Chair: Chul Woo Yang, Ph.D, The Catholic University of Korea

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chong Kun Dang Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT05193565
    Other Study ID Numbers:
    • B110_02KT2103
    First Posted:
    Jan 18, 2022
    Last Update Posted:
    Feb 1, 2022
    Last Verified:
    Dec 1, 2021
    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 Transplantation
    Sirolimus
    Additional relevant MeSH terms:
    Mycophenolic Acid
    Sirolimus

    Study Results

    No Results Posted as of Feb 1, 2022