NCT05193565

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 206 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
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
DRUG	Mycophenolate mofetil	Up to 1g BID(total 2g daily), PO

Timeline

• Start date: 2021-11-19
• Primary completion: 2026-07-01
• Completion: 2026-11-01
• First posted: 2022-01-18
• Last updated: 2026-02-17

Locations

1 site across 1 country: South Korea