Heart TransplantPhase 4OPTIMIZE-HTxNCT06942156
Optimize Immunosuppressive Therapy Using Everolimus and Low-dose Calcineurin Inhibitors in Heart Transplant Patients in Korea
A Phase 4 study testing Everolimus and Mycophenolate mofetil Tablet/Capsule in people with Heart Transplant, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Transplant
- What is being tested?
- Everolimus and Mycophenolate mofetil Tablet/Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Aug 2025to Dec 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Samsung Medical Center
Seoul, Seoul, 06351
Jin-O Choi, MD, PhD, choijean5@gmail.com
Seyoung Jung, 82-2-6373-0791, seyoung.jung@ckdpharm.com
About this study
Official title: 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.
Read the 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
- Being tested
- Everolimus, Mycophenolate mofetil Tablet/Capsule
- Keywords
- Heart transplant, Everolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called Certirobell Tablet
Up to 1.5g BID(total 3g daily), PO - Check the blood concentration of Everolimus at each visit
Mycophenolate mofetil Tablet/CapsuleDrug
Also called Myrept® Cap./Tab.
Up to 1.5g BID(total 3g daily), PO
| Study group | Role | What they receive |
|---|---|---|
| Certirobell Tablet | Experimental | Everolimus Receives: Drug: Everolimus |
| Myrept Tablet/Capsule | Active comparator | Mycophenolate mofetil Receives: Drug: Mycophenolate mofetil Tablet/Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 12 months
Secondary outcomes (4)
Graft rejection
Time to onset of Graft rejection
Measured: Baseline and 6, 12 months after drug administrations
Newly developed Graft dysfunction
Frequency of incidence
Measured: Baseline and 6, 12 months after drug administrations
Change in renal function
Change in eGFR
Measured: 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
Measured: Until 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start14 Aug 2025 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin-O Choi, MD, PhD, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942156
- Sponsor's protocol ID
- B95_05HTx2501
- Acronym
- OPTIMIZE-HTx
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06942156
- Acronym / sponsor ID
- OPTIMIZE-HTx / B95_05HTx2501
- Conditions
- Heart Transplant
- Keywords
- Heart transplant, Everolimus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2025 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Certirobell Tablet | Experimental | Drug: EverolimusEverolimus |
| Myrept Tablet/Capsule | Active comparator | Drug: Mycophenolate mofetil Tablet/CapsuleMycophenolate mofetil |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EverolimusAlso: Certirobell TabletUp to 1.5g BID(total 3g daily), PO - Check the blood concentration of Everolimus at each visit | Drug | Certirobell Tablet |
| Mycophenolate mofetil Tablet/CapsuleAlso: Myrept® Cap./Tab.Up to 1.5g BID(total 3g daily), PO | Drug | Myrept Tablet/Capsule |
Primary outcome
hierarchical composite assessed using the win-ratio
Time frame: 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.
4 secondary outcomes
Graft rejection
Time frame: Baseline and 6, 12 months after drug administrations
Newly developed Graft dysfunction
Time frame: Baseline and 6, 12 months after drug administrations
Change in renal function
Time frame: Baseline and 6, 12 months after drug administrations
CAV ISHLT grade
Time frame: Until 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jin-O Choi, MD, PhD study chair
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Everolimus and Mycophenolate mofetil Tablet/Capsule in people with Heart Transplant, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jin-O Choi, MD, PhD (02-3410-3419, choijean5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hierarchical composite assessed using the win-ratio (time frame: baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.