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

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]

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Kidney Transplantation
• Intervention / Treatment: Drug: Sirolimus; Drug: Mycophenolate mofetil

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 Type: Interventional
• Enrollment (Estimated): 206
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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/mm^3, or platelet < 75,000/mm^3, or ANC < 1,300/ mm^3
   • Protein/Creatinine ratio≥1.0(mg/mg)
3. Patents who had a record of taking mTOR inhibitor before 3 months
4. In investigator's judgement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of composite efficacy failure	Composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure	Until 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of biopsy-confirmed acute rejection(TCMR, AMR)	The frequency and Incidence	Until 24 weeks
Pathologic Results, Occurrence, Treatment Methods, and Results of Acute Rejection Confirmed by Biopsy	By Banff classification categories	Until 24 weeks
Survival rate of transplanted organ	Kaplan-Meier	Until 24 weeks
Survival rate of Patients	Kaplan-Meier	Until 24 weeks
Serum-Cr, eGFR	eGFR using MDRD	Until 24 weeks
Incidence of BKV, CMV infection	The frequency and Incidence	Until 24 weeks

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Study Chair: Jae Berm Park, Ph.D, Samsung Medical Center, Sungkyunkwan University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Kidney Transplantation; Sirolimus
• Additional Relevant MeSH Terms: Organic Chemicals; Fatty Acids; Lipids; Acids, Acyclic; Carboxylic Acids; Macrolides; Lactones; Caproates; Sirolimus; Mycophenolic Acid
• Other Study ID Numbers: B110_02KT2103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No