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

Phase 4

Not yet recruiting

• Conditions: Heart Transplant
• Interventions: Drug: Everolimus; Drug: Mycophenolate mofetil Tablet/Capsule

• Registration Number: NCT06942156
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief 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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-21
• Last Update Submitted: 2025-04-21
• Study First Posted: 2025-04-24
• Last Update Posted: 2025-04-24
• Study Start: 2025-08-14
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Over 19 years old
2. Patients with stable heart transplant graft function at least 28~100 days post transplant.
3. Patients who are appropriate for combination therapy with Everolimus and Calcineurin inhibitor (CNI) at the investigator's discretion

Exclusion Criteria

1. Recipients who have had a prior organ transplant, or who underwent a heart transplant with the simultaneous transplantation of another organ.
2. Recipients of heart from ABO-incompatible donor
3. Recipients of heart from the donor aged 70 or older

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Certirobell Tablet	Everolimus	Everolimus
Myrept Tablet/Capsule	Mycophenolate mofetil Tablet/Capsule	Mycophenolate mofetil

Primary Outcome Measures

Name	Time	Method
hierarchical composite assessed using the win-ratio	baseline, 12 months	hierarchical composite assessed using the win-ratio, including graft survival, treated rejection episodes, change in percent atheroma volume, and change in eGFR.

Secondary Outcome Measures

Name	Time	Method
Graft rejection	Baseline and 6, 12 months after drug administrations	Time to onset of Graft rejection
Newly developed Graft dysfunction	Baseline and 6, 12 months after drug administrations	Frequency of incidence
Change in renal function	Baseline and 6, 12 months after drug administrations	Change in eGFR
CAV ISHLT grade	Until 12 months	Coronary Arterial Vasculopathy(CAV) assessed by ISHLT grade for CAV (ISHLT: International Society for Heart and Lung Transplantation); * CAV0 (Not significant): No detectable angiographic lesion; * CAV1 (Mild): Angiographic LM\<50% or Primary vessel with maximum lesion\<70% or Branch stenosis\<70%; * CAV2 (Moderate): Angiographic LM\<50%, Single primary vessel≥70% or Isolated branch stenosis in 2 system≥70%; * CAV3 (Severe): Angiographic LM≥50% or ≥2 primary vessels ≥70% or Isolated branch stenosis in all 3 system≥70% or CAV1 or CAV2 with allograft dysfunction (LVEF≤45%) or evidence of significant restrictive physiology

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of