Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-02 @ 10:19 AM
Study NCT ID:
NCT06942156
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-24
First Post:
2025-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimize Immunosuppressive Therapy Using Everolimus and Low-dose Calcineurin Inhibitors in Heart Transplant Patients in Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D002214', 'term': 'Capsules'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2025-04-11', 'studyFirstSubmitQcDate': '2025-04-21', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hierarchical composite assessed using the win-ratio', 'timeFrame': 'baseline, 12 months', 'description': 'hierarchical composite assessed using the win-ratio, including graft survival, treated rejection episodes, change in percent atheroma volume, and change in eGFR.'}], 'secondaryOutcomes': [{'measure': 'Graft rejection', 'timeFrame': 'Baseline and 6, 12 months after drug administrations', 'description': 'Time to onset of Graft rejection'}, {'measure': 'Newly developed Graft dysfunction', 'timeFrame': 'Baseline and 6, 12 months after drug administrations', 'description': 'Frequency of incidence'}, {'measure': 'Change in renal function', 'timeFrame': 'Baseline and 6, 12 months after drug administrations', 'description': 'Change in eGFR'}, {'measure': 'CAV ISHLT grade', 'timeFrame': 'Until 12 months', 'description': 'Coronary Arterial Vasculopathy(CAV) assessed by ISHLT grade for CAV (ISHLT: International Society for Heart and Lung Transplantation)\n\n* CAV0 (Not significant): No detectable angiographic lesion\n* CAV1 (Mild): Angiographic LM\\<50% or Primary vessel with maximum lesion\\<70% or Branch stenosis\\<70%\n* CAV2 (Moderate): Angiographic LM\\<50%, Single primary vessel≥70% or Isolated branch stenosis in 2 system≥70%\n* 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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart transplant', 'Everolimus'], 'conditions': ['Heart Transplant']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Over 19 years old\n2. Patients with stable heart transplant graft function at least 28\\~100 days post transplant.\n3. Patients who are appropriate for combination therapy with Everolimus and Calcineurin inhibitor (CNI) at the investigator's discretion\n\nExclusion Criteria:\n\n1. Recipients who have had a prior organ transplant, or who underwent a heart transplant with the simultaneous transplantation of another organ.\n2. Recipients of heart from ABO-incompatible donor\n3. Recipients of heart from the donor aged 70 or older"}, 'identificationModule': {'nctId': 'NCT06942156', 'acronym': 'OPTIMIZE-HTx', 'briefTitle': 'Optimize Immunosuppressive Therapy Using Everolimus and Low-dose Calcineurin Inhibitors in Heart Transplant Patients in Korea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'B95_05HTx2501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Certirobell Tablet', 'description': 'Everolimus', 'interventionNames': ['Drug: Everolimus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Myrept Tablet/Capsule', 'description': 'Mycophenolate mofetil', 'interventionNames': ['Drug: Mycophenolate mofetil Tablet/Capsule']}], 'interventions': [{'name': 'Everolimus', 'type': 'DRUG', 'otherNames': ['Certirobell Tablet'], 'description': 'Up to 1.5g BID(total 3g daily), PO - Check the blood concentration of Everolimus at each visit', 'armGroupLabels': ['Certirobell Tablet']}, {'name': 'Mycophenolate mofetil Tablet/Capsule', 'type': 'DRUG', 'otherNames': ['Myrept® Cap./Tab.'], 'description': 'Up to 1.5g BID(total 3g daily), PO', 'armGroupLabels': ['Myrept Tablet/Capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Jin-O Choi, MD, PhD', 'role': 'CONTACT', 'email': 'choijean5@gmail.com'}, {'name': 'Seyoung Jung', 'role': 'CONTACT', 'email': 'seyoung.jung@ckdpharm.com', 'phone': '82-2-6373-0791'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jin-O Choi, MD, PhD', 'role': 'CONTACT', 'email': 'choijean5@gmail.com', 'phone': '02-3410-3419'}], 'overallOfficials': [{'name': 'Jin-O Choi, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}