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]

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05193565

Enrollment

206

Registered

2022-01-18

Start date

2021-11-19

Completion date

2026-11-01

Last updated

2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

Kidney Transplantation, Sirolimus

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.

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.

Interventions

DRUGSirolimus

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

DRUGMycophenolate mofetil

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Contacts

STUDY_CHAIRJae Berm Park, Ph.D

Samsung Medical Center, Sungkyunkwan University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026