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NCT Number: NCT05193565

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Kidney Transplantation

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, South Korea

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who at least 1 year and less than 10 years after kidney transplantation
  • Over 20 years old
  • Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolic acid after kidney transplantation

Exclusion criteria

  • Patients who have transplanted organs other than kidney
  • 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
  • Protein/Creatinine ratio≥1.0(mg/mg)
  • Patents who had a record of taking mTOR inhibitor before 3 months
  • In investigator's judgement

Treatment and study plan

sirolimus

Drug

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.

Mycophenolate mofetil

Drug

Up to 1g BID(total 2g daily), PO

Other names: Myrept® Cap./Tab.

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of biopsy-confirmed acute rejection(TCMR, AMR)

    Time frame: Until 24 weeks

    The frequency and Incidence

  2. Pathologic Results, Occurrence, Treatment Methods, and Results of Acute Rejection Confirmed by Biopsy

    Time frame: Until 24 weeks

    By Banff classification categories

  3. Survival rate of transplanted organ

    Time frame: Until 24 weeks

    Kaplan-Meier

  4. Survival rate of Patients

    Time frame: Until 24 weeks

    Kaplan-Meier

  5. Serum-Cr, eGFR

    Time frame: Until 24 weeks

    eGFR using MDRD

  6. Incidence of BKV, CMV infection

    Time frame: Until 24 weeks

    The frequency and Incidence

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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]

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 18, 2022
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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