NCT06044493

MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients

A Multicenter, Randomization, Open-label Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to Evaluate the Efficacy and Safety of MYREPTIC-N® or MY-REPT® in Stable Patients after Kidney Transplant Recipients

Detailed description

This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety of MYREPTIC-N® or MY-REPT® administration for 24 weeks in renal transplant patients combined Calcineurin inhibitor.

Conditions

• Kidney Transplant

Interventions

Type	Name	Description
DRUG	Myreptic-N Tablet	Up to 720mg BID(total 1440mg daily), PO - Check the blood concentration of Mycophenolate at each visit
DRUG	Mycophenolate mofetil Tablet/Capsule	Up to 1g BID(total 2g daily), PO - Check the blood concentration of Mycophenolate at each visit

Timeline

• Start date: 2023-11-14
• Primary completion: 2025-10-29
• Completion: 2025-10-29
• First posted: 2023-09-21
• Last updated: 2026-04-15

Locations

1 site across 1 country: South Korea