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ACTIVE NOT RECRUITING
NCT05193565
PHASE4

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

Sponsor: Chong Kun Dang Pharmaceutical

View on ClinicalTrials.gov

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.

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]

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

206

Start Date

2021-11-19

Completion Date

2026-11

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

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

Locations (1)

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

Seoul, South Korea