Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-31 @ 4:37 AM
Study NCT ID:
NCT01842269
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2013-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of My-Rept® Tablet vs. My-Rept® Capsule in Combination With Tacrolimus in Kidney Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009173', 'term': 'Mycophenolic Acid'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-18', 'studyFirstSubmitDate': '2013-04-25', 'studyFirstSubmitQcDate': '2013-04-25', 'lastUpdatePostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of efficacy failure', 'timeFrame': 'up to 26 weeks', 'description': 'efficacy failure=acute rejection by kidney biopsy,graft loss, death'}], 'secondaryOutcomes': [{'measure': 'Rate of acute rejection by kidney biopsy', 'timeFrame': 'up to 26 weeks'}, {'measure': 'Survival with no graft loss', 'timeFrame': 'up to 26 weeks'}, {'measure': 'eGFR(using by MDRD method)', 'timeFrame': 'up to 26 weeks'}, {'measure': 'Number of Participants with Adverse Events', 'timeFrame': 'up to 26 weeks', 'description': '* Rate of adverse events\n* Evaluated safety parameters included: Physical examination, laboratory test, etc.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mycophenolate Mofetil', 'MMF'], 'conditions': ['Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'Efficacy and Safety of My-Rept® Tablet(Mycophenolate Mofetil 500mg/Tab.) versus My-Rept® Capsule(Mycophenolate Mofetil 250mg/Cap.) in Combination with Tacrolimus in Kidney Transplant Patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 20 years or older.\n2. Patient who receive primary or secondary kidney transplantation from living or brain-dead donor .\n3. Patient who receive age 20 years or older donor.\n4. Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Cold Ischemia Time \\> 30 hours.\n2. Patient who receive HLA-identical donor.\n3. Patient with dual kidney transplantation recipient or have history of other organ transplantation in past or current.\n4. Patient who receive extra-renal solid organ or bone marrow stem cell transplantation.\n5. Patient who receive kidney transplantation from non-heart beating cadaveric donor(organ donor after cardiac death\n6. Patient who receive kidney transplantation from ABO blood type mismatching donor or lymphocyte cross matching (LCM) positive donor.\n7. Patient with cancer within 5 years, except cured skin cancer patient(Squamous cell or basal cell carcinoma)\n8. Positive in serology test(HIV, HBsAg, HCV) in recipients and/or donor.\n9. Patient with Severe gastrointestinal disease in screening period by investigator's decision.\n10. Patient with systemic severe infection requiring treatment (able to transplantation after completely disappear or is controlled infection)\n11. Liver cirrhosis, clinically significant portal hypertension or other moderate to severe liver disease.\n12. Defined by the following laboratory parameters before screening period\n\n 1. One of liver function test(AST, ALT, ALP, Total Bilirubin)results increased more than 3 times upper limit of normal range\n 2. WBC \\<2,500/mm3, Platelet \\<75,000/mm3\n13. Acute (within 4 weeks) or chronic(need to treatments) allergic/hypersensitivity reaction in the history of Investigational drugs (ex, mycophenolate acid or tacrolimus, etc.) or additives.\n14. Administration of other Investigational drugs and/or immunosuppressants within 28days before screening period (except allowed immunosuppressants in protocol)\n15. Women in pregnant or breast-feeding or don't using adequate contraception.\n16. Patient has conversation impairment because alcohol or drugs addiction history within 6months or mental illness, etc.\n17. In investigator's judgment"}, 'identificationModule': {'nctId': 'NCT01842269', 'acronym': 'My-Rept_KT_P4', 'briefTitle': 'Evaluate the Efficacy and Safety of My-Rept® Tablet vs. My-Rept® Capsule in Combination With Tacrolimus in Kidney Transplant Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'Open Label, Randomized, Multi-center, Phase 4 Trial to Evaluate the Efficacy and Safety of My-Rept® Tablet(Mycophenolate Mofetil 500mg/Tab.) Versus My-Rept® Capsule(Mycophenolate Mofetil 250mg/Cap.) in Combination With Tacrolimus for 26 Weeks in Kidney Transplant Patients', 'orgStudyIdInfo': {'id': '223KTP12003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'My-Rept® Tablet', 'description': 'My-Rept® Tablet, Mycophenolate Mofetil 500mg, orally', 'interventionNames': ['Drug: Mycophenolate Mofetil 500mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'My-Rept® Capsule', 'description': 'My-Rept® Capsule, Mycophenolate Mofetil 250mg, orally', 'interventionNames': ['Drug: Mycophenolate Mofetil 250mg']}], 'interventions': [{'name': 'Mycophenolate Mofetil 500mg', 'type': 'DRUG', 'otherNames': ['My-Rept® Tablet'], 'armGroupLabels': ['My-Rept® Tablet']}, {'name': 'Mycophenolate Mofetil 250mg', 'type': 'DRUG', 'otherNames': ['My-Rept® Capsule'], 'armGroupLabels': ['My-Rept® Capsule']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'country': 'South Korea', 'facility': 'Maryknoll Medical Center', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Yeungnam University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Iksan', 'country': 'South Korea', 'facility': 'Wonkwang University School of Medical & Hospital', 'geoPoint': {'lat': 35.94389, 'lon': 126.95444}}, {'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Chunbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Bundang CHA Medical Center', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kandong Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwan', 'country': 'South Korea', 'facility': 'Ajou University Hospital'}, {'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'overallOfficials': [{'name': 'Yu Seun Kim, Ph. D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}