Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT01015456
Status:
TERMINATED
Last Update Posted:
2014-10-10
First Post:
2009-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) (Myfortic) in The Treatment of Relapse or Resistant Proliferative Lupus Nephritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], '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': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'whyStopped': "Data Safety Monitoring Board concerning of the participants' safety", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-09', 'studyFirstSubmitDate': '2009-11-17', 'studyFirstSubmitQcDate': '2009-11-17', 'lastUpdatePostDateStruct': {'date': '2014-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of enteric-coated Mycophenolate Sodium at 12 months in the treatment of lupus nephritis', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'The cost-effectiveness of using enteric-coated Mycophenolate Sodium as compared to standard treatment', 'timeFrame': '12 months'}, {'measure': 'The ratio of patients with declined renal function', 'timeFrame': '12 months'}, {'measure': 'Time to remission', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lupus nephritis', 'mycophenolate sodium', 'cyclophosphamide'], 'conditions': ['Lupus Nephritis']}, 'referencesModule': {'references': [{'pmid': '26835147', 'type': 'DERIVED', 'citation': 'Anutrakulchai S, Panaput T, Wongchinsri J, Chaishayanon S, Satirapoj B, Traitanon O, Pima W, Rukrung C, Thinkhamrop B, Avihingsanon Y. A multicentre, randomised controlled study of enteric-coated mycophenolate sodium for the treatment of relapsed or resistant proliferative lupus nephritis: an Asian experience. Lupus Sci Med. 2016 Jan 14;3(1):e000120. doi: 10.1136/lupus-2015-000120. eCollection 2016.'}], 'seeAlsoLinks': [{'url': 'http://www.lupus.research.chula.ac.th/', 'label': 'Lupus Research Unit'}]}, 'descriptionModule': {'briefSummary': 'To investigate the efficacy and safety of enteric-coated mycophenolate sodium (Myfortic) as compared to intravenous cyclophosphamide in the treatment of active nephritis. The primary outcomes are complete and partial renal remission, as assessed by renal function, urinary sediment and proteinuria in patients with International Society of Nephrology/ Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis.', 'detailedDescription': 'In this study, there are two sub-studies in order to define secondary endpoints.\n\n1. Pharmacokinetics study of Mycophenolic acid\n2. Identify biomarkers for therapy-resistant prediction.\n3. Identify biomarkers for predicting a loss of kidney function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 16 years of above at the time of screening\n* ability and willingness to provide written informed consent (or to obtain consent from parent guardian where applicable) and to comply with the schedule of protocol requirements\n* Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE. The 4 criteria do not have to be present at the time of screening\n* Active lupus nephritis defined as follows: Biopsy proven (within 16 weeks prior to screening) ISN Class III or IV (A or A/C) not include III(C) IV(C) and VI (\\>90% chronic irreversible scarring)\n* Relapse or resistant to (3 consecutive doses) IVCY\n* Resistant lupus or Relapse lupus nephritis defined as follows:\n\n * Increase in serum creatinine \\>/= 0.3 mg/dl or\n * Increase in proteinuria \\> 1.5 g/day (which must have improved by ≥ 50% in the preceding 3 months)\n* Life-time cumulative dose of IVCY \\> 6 grams\n* Female patients of childbearing potential must have a negative serum pregnancy\n\nExclusion Criteria:\n\nRelates to SLE\n\n* Diagnosis of rapid progressive glomerulonephritis (RPGN): doubling serum creatinine and/or crescentic glomeruli ≥ 30%\n* Severe renal impairment as defined by calculated creatinine clearance or MDRD-GFR \\< 30 ml/min(except creatinine clearance or MDRD-GFR \\> 50 ml/min in the 12 weeks prior to screening)\n* History of serious disease or complication in any organ system that not appropriate to treatment immunosuppressive drug groups.\n* Severe extra-renal organ involvement\n\nRelated to Treatment\n\n* Previous of any Mycophenolate groups in the 6 months prior to screening\n* Treatment with any investigational drugs in the 3 months prior to screening\n\nRelated to General Health\n\n* Pregnancy or breast feeding mothers.\n* Concomitant condition which has required treatment moderate to high dose steroid in the 12 weeks prior to screening.\n* Evidence of significant uncontrolled concomitant disease in any organ system not related to SLE.\n* History of cancer, including solid tumors, hematological malignancies and carcinoma.\n* Evidence of current abuse of drugs or alcohol.\n\nRelated to Laboratory Findings\n\n* Neutrophile \\< 1,500/mm3, Hb \\< 7g/L, Platelet \\< 50,000/mm3 (except active SLE)\n* Positive HBsAg or anti-HCV or anti-HIV.'}, 'identificationModule': {'nctId': 'NCT01015456', 'acronym': 'CONTROL', 'briefTitle': 'The Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) (Myfortic) in The Treatment of Relapse or Resistant Proliferative Lupus Nephritis', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'The Clinical Efficacy and Economic Evaluation of EC-MPS (Myfortic) in the Treatment of Relapse or Resistant Proliferative Lupus Nephritis', 'orgStudyIdInfo': {'id': '2009-001'}, 'secondaryIdInfos': [{'id': 'Lupus Research Unit'}, {'id': 'CRCN'}, {'id': 'HITAP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Oral mycophenolate sodium 1440 mg per day for 12 months', 'interventionNames': ['Drug: mycophenolate sodium']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Intravenous cyclophosphamide monthly for 6 months', 'interventionNames': ['Drug: cyclophosphamide']}], 'interventions': [{'name': 'mycophenolate sodium', 'type': 'DRUG', 'otherNames': ['Myfortic'], 'description': 'per oral, twice daily, for 12 months', 'armGroupLabels': ['1']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cytoxan'], 'description': 'intravenous, monthly, for 6 months', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Khon Kaen', 'state': 'Changwat Khon Kaen', 'country': 'Thailand', 'facility': 'Khon Kaen University', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Nopparat Rajathani', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Pathum Thani', 'country': 'Thailand', 'facility': 'Thammasart University', 'geoPoint': {'lat': 14.01346, 'lon': 100.53049}}], 'overallOfficials': [{'name': 'Yingyos Avihingsanon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chulalongkorn University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinical Research Collaborative Network', 'class': 'NETWORK'}, {'name': 'Health Intervention and Technology Assessment Program (HITAP)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor.', 'investigatorFullName': 'Yingyos Avihingsanon', 'investigatorAffiliation': 'Chulalongkorn University'}}}}