Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT03794492
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2019-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D002214', 'term': 'Capsules'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D000077552', 'term': 'Basiliximab'}], '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'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-21', 'studyFirstSubmitDate': '2019-01-03', 'studyFirstSubmitQcDate': '2019-01-03', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DSA(Donor-specific Anti-HLA Antibody)', 'timeFrame': '36 months', 'description': 'Incidence of DSA(Donor-specific Anti-HLA Antibody) up to 36months after Kidney transplantation'}], 'secondaryOutcomes': [{'measure': 'Incidence of composite efficacy failure', 'timeFrame': '12, 24, 36months', 'description': 'The frequency and percentage of composite efficacy failure (Treated-BPAMR \\& ACR, graft loss, death and follow-up loss)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplant']}, 'descriptionModule': {'briefSummary': 'Efficacy and Safety of My-Rept® (Mycophenolate Mofetil 500mg/Tab. or 250mg/Cap.) in Combination with Tacrolimus, Methylprednisolone, Simulect in Kidney Transplant Patients', 'detailedDescription': 'This study is a multi-center, non-comparative and phase IV clinical trial that evaluates incidence of Donor-Specific Antibody for 36 months after kidney transplantation when administered with Tacrolimus, Mycophenolate mofetil, and corticosteroid'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Over 19 years old(male or female)\n2. Patients who are planning to receive a kidney from a deceased or a living unrelated/related donor\n3. Agreement with written informed consent\n\nExclusion Criteria:\n\n1. Donor's HLA antigen matches recipient or the Degree of Mis-Match is 0\n2. Patients with high sensitization who need desensitization therapy\n3. Multi organ recipients or previous transplant with any organs\n4. Diagnosed with cancer within five years\n5. Patient who receive kidney from ABO incompatibility donor or Lymphocyte cross-match positive donor\n6. Patients who have positive HIV, HBsAg or Anti-HCV test result\n7. At screening\n\n * Under treatment for active liver disease, or Over 3times upper than normal range of liver function test (T-bilirubin, AST, ALT)\n * WBC\\<2,500/mm3, PLT \\<50,000/mm3, ANC\\<1,500/mm3\n8. Pregnant or lactating women\n9. In investigator's judgment"}, 'identificationModule': {'nctId': 'NCT03794492', 'briefTitle': 'Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome: Open-label, Multi-center, Single Arm, Phase 4 Trial (DoSAKOM)', 'orgStudyIdInfo': {'id': '223KT17017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mycophenolate mofetil', 'description': 'One arm: Mycophenolate mofetil 500mg Tab. or 250mg Cap.', 'interventionNames': ['Drug: Mycophenolate mofetil 500mg Tab. or 250mg Cap.', 'Drug: Tacrolimus', 'Drug: Methylprednisolone/prednisolone', 'Drug: Basiliximab']}], 'interventions': [{'name': 'Mycophenolate mofetil 500mg Tab. or 250mg Cap.', 'type': 'DRUG', 'otherNames': ['Myrept® Cap./Tab.'], 'description': '\\- Orally, up to 1g BID(total 2g daily)', 'armGroupLabels': ['Mycophenolate mofetil']}, {'name': 'Tacrolimus', 'type': 'DRUG', 'description': '\\- Orally, check the blood ceocentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3-8ng/ml', 'armGroupLabels': ['Mycophenolate mofetil']}, {'name': 'Methylprednisolone/prednisolone', 'type': 'DRUG', 'description': '\\- Methyprednisolone 500mg / Prednisolone 5mg', 'armGroupLabels': ['Mycophenolate mofetil']}, {'name': 'Basiliximab', 'type': 'DRUG', 'description': '\\- IV, 20mg(before Kidney transplat) / 20mg(Day 4 of kidney transplant)', 'armGroupLabels': ['Mycophenolate mofetil']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suwan', 'country': 'South Korea', 'facility': 'Ajou University Hospital'}], 'overallOfficials': [{'name': 'Chang-Kwan Oh, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Ajou University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}