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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Transplant
• Intervention / Treatment: Drug: Everolimus; Drug: Mycophenolate mofetil Tablet/Capsule

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 Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jin-O Choi, MD, PhD; Phone Number: 02-3410-3419; Email: choijean5@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
    • Contact: Jin-O Choi, MD, PhD; Email: choijean5@gmail.com
    • Contact: Seyoung Jung; Phone Number: 82-2-6373-0791; Email: seyoung.jung@ckdpharm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Myrept Tablet/Capsule; Mycophenolate mofetil	Drug: Mycophenolate mofetil Tablet/Capsule; Up to 1.5g BID(total 3g daily), PO; Other Names: Myrept® Cap./Tab.
Experimental: Certirobell Tablet; Everolimus	Drug: Everolimus; Up to 1.5g BID(total 3g daily), PO - Check the blood concentration of Everolimus at each visit; Other Names: Certirobell Tablet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft rejection	Time to onset of Graft rejection	Baseline and 6, 12 months after drug administrations
Newly developed Graft dysfunction	Frequency of incidence	Baseline and 6, 12 months after drug administrations
Change in renal function	Change in eGFR	Baseline and 6, 12 months after drug administrations
CAV ISHLT grade	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	Until 12 months

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Study Chair: Jin-O Choi, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): August 14, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 21, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Heart transplant; Everolimus
• Additional Relevant MeSH Terms: MTOR Inhibitors; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Antibiotics, Antitubercular; Antitubercular Agents; Everolimus; Mycophenolic Acid
• Other Study ID Numbers: B95_05HTx2501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No