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
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2025
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2025
CompletedFirst Posted
Study publicly available on registry
April 24, 2025
CompletedStudy Start
First participant enrolled
August 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
April 24, 2025
April 1, 2025
5.3 years
April 11, 2025
April 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Graft rejection
Baseline and 6, 12 months after drug administrations
Newly developed Graft dysfunction
Baseline and 6, 12 months after drug administrations
Change in renal function
Baseline and 6, 12 months after drug administrations
CAV ISHLT grade
Until 12 months
Study Arms (2)
Certirobell Tablet
EXPERIMENTALEverolimus
Myrept Tablet/Capsule
ACTIVE COMPARATORMycophenolate mofetil
Interventions
Up to 1.5g BID(total 3g daily), PO - Check the blood concentration of Everolimus at each visit
Up to 1.5g BID(total 3g daily), PO
Eligibility Criteria
You may qualify if:
- Over 19 years old
- Patients with stable heart transplant graft function at least 28\~100 days post transplant.
- Patients who are appropriate for combination therapy with Everolimus and Calcineurin inhibitor (CNI) at the investigator's discretion
You may not qualify if:
- Recipients who have had a prior organ transplant, or who underwent a heart transplant with the simultaneous transplantation of another organ.
- Recipients of heart from ABO-incompatible donor
- Recipients of heart from the donor aged 70 or older
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, Seoul, 06351, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jin-O Choi, MD, PhD
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2025
First Posted
April 24, 2025
Study Start
August 14, 2025
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
April 24, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share