NCT06942156

Optimize Immunosuppressive Therapy Using Everolimus and Low-dose Calcineurin Inhibitors in Heart Transplant Patients in Korea

A Prospective, Multicenter, Open-Label, Randomized, Comparative, Phase 4 Trial to Optimize Immunosuppressive Therapy Using Everolimus and Low-dose Calcineurin Inhibitors in Heart Transplant Patients in Korea

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• 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 lower dose calcineurin inhibitors (CNI) in combination with Everolimus in Korean heart transplant recipients.

Detailed description

This study is a prospective, multicenter, open-label, randomized, comparative, phase 4 trial to optimize immunosuppressive therapy using everolimus and low-dose calcineurin inhibitors in heart transplant patients in Korea.

Conditions

• Heart Transplant

Interventions

Type	Name	Description
DRUG	Everolimus	Up to 1.5g BID(total 3g daily), PO - Check the blood concentration of Everolimus at each visit
DRUG	Mycophenolate mofetil Tablet/Capsule	Up to 1.5g BID(total 3g daily), PO

Timeline

• Start date: 2025-08-14
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2025-04-24
• Last updated: 2025-04-24

Locations

1 site across 1 country: South Korea