Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:45 PM
Study NCT ID:
NCT06044493
Status:
RECRUITING
Last Update Posted:
2024-12-16
First Post:
2023-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D002214', 'term': 'Capsules'}], 'ancestors': [{'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 158}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2023-08-24', 'studyFirstSubmitQcDate': '2023-09-13', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of composite efficacy failure', 'timeFrame': 'Until 24 weeks', 'description': 'Composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure'}], 'secondaryOutcomes': [{'measure': 'Change in survey evaluation score [Gastrointestinal symptom rating scale(GSRS), EuroQol-5D(EQ-5D)]', 'timeFrame': 'Changes in scores from the baseline at week 24', 'description': 'The GSRS consists of 15 questions, with a total score of 15 to 105, indicating that the higher the total score, the more severe the gastrointestinal symptoms.\n\nThe EQ-5D evaluates quality of life and consists of 5 questions. Each question is evaluated in the range of 1 to 5. The score is calculated according to EQ-5D index. Calculated score is lower that means poor health.'}, {'measure': 'Intra patient variability of mycophenolic acid', 'timeFrame': 'Until 24 weeks', 'description': 'Measurement of blood levels of mycophenolic acid'}, {'measure': 'Intra patient variability of calcineurin inhibitor', 'timeFrame': 'Until 24 weeks', 'description': 'Measurement of blood levels of calcineurin inhibitor'}, {'measure': 'Incidence of Virus infection', 'timeFrame': 'Until 24 weeks', 'description': 'Frequency of incidence (BK Virus, CMV)'}, {'measure': 'Incidence of biopsy-confirmed acute rejection', 'timeFrame': 'Until 24 weeks', 'description': 'Frequency of incidence'}, {'measure': 'Incidence of Graft loss', 'timeFrame': 'Until 24 weeks', 'description': 'Frequency of incidence'}, {'measure': 'Incidence of Death', 'timeFrame': 'Until 24 weeks', 'description': 'Frequency of incidence'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney transplant', 'Mycophenolic acid'], 'conditions': ['Kidney Transplant']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to Evaluate the Efficacy and Safety of MYREPTIC-N® or MY-REPT® in Stable Patients after Kidney Transplant Recipients', 'detailedDescription': 'This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety of MYREPTIC-N® or MY-REPT® administration for 24 weeks in renal transplant patients combined Calcineurin inhibitor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Over 19 years old\n2. Patients who at least 1 year after kidney transplant\n3. serum creatinine ≤2.3 mg/dL\n4. Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolate Mofetil after kidney transplantation\n\nExclusion Criteria:\n\n1. Patients who had received treatment Acute rejection within 4 weeks\n2. Patients who had discontinued corticosteroid within 4 weeks\n3. At the time of Screening\n\n * Treatment with active liver disease or Liver function test(T-bilirubin, AST, ALT)is over 3 times than upper normal limit\n * WBC\\< 2,500/mm\\^3, or platelet \\< 75,000/mm\\^3, or ANC \\< 1,300/ mm\\^3\n4. In investigator's judgement"}, 'identificationModule': {'nctId': 'NCT06044493', 'acronym': 'MyMy', 'briefTitle': 'MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'A Multicenter, Randomization, Open-label Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients', 'orgStudyIdInfo': {'id': 'B130_01KT2203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Myreptic-N Tablet', 'description': 'Mycophenolate sodium', 'interventionNames': ['Drug: Myreptic-N Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Myrept Tablet/Capsule', 'description': 'Mycophenolate mofetil', 'interventionNames': ['Drug: Mycophenolate mofetil Tablet/Capsule']}], 'interventions': [{'name': 'Myreptic-N Tablet', 'type': 'DRUG', 'otherNames': ['Myreptic-N®'], 'description': 'Up to 720mg BID(total 1440mg daily), PO - Check the blood concentration of Mycophenolate at each visit', 'armGroupLabels': ['Myreptic-N Tablet']}, {'name': 'Mycophenolate mofetil Tablet/Capsule', 'type': 'DRUG', 'otherNames': ['Myrept® Cap./Tab.'], 'description': 'Up to 1g BID(total 2g daily), PO - Check the blood concentration of Mycophenolate at each visit', 'armGroupLabels': ['Myrept Tablet/Capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jongwon Ha, MD, PhD', 'role': 'CONTACT', 'email': 'jwhamd@snu.ac.kr', 'phone': '82-2-2072-2991'}, {'name': 'Jung A Lee', 'role': 'CONTACT', 'email': 'junaa82@ckdpharm.com', 'phone': '82-2-2194-0403'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jogwon Ha, MD, PhD', 'role': 'CONTACT', 'email': 'jwhamd@snu.ac.kr', 'phone': '82-2-2072-2991'}, {'name': 'Jung A Lee', 'role': 'CONTACT', 'email': 'junaa82@ckdpharm.com', 'phone': '82-2-2194-0403'}], 'overallOfficials': [{'name': 'Jongwon Ha, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}