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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Certirobell Tablet | Experimental | Everolimus |
|
| Myrept Tablet/Capsule | Active Comparator | Mycophenolate mofetil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | Up to 1.5g BID(total 3g daily), PO - Check the blood concentration of Everolimus at each visit |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin-O Choi, MD, PhD | Contact | 02-3410-3419 | choijean5@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jin-O Choi, MD, PhD | Samsung Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | Seoul | 06351 | South Korea |
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| Mycophenolate mofetil Tablet/Capsule | Drug | Up to 1.5g BID(total 3g daily), PO |
|
|
| 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)
| Until 12 months |
| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D009173 | Mycophenolic Acid |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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