Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-28 @ 9:27 PM
Study NCT ID:
NCT01042457
Status:
COMPLETED
Last Update Posted:
2013-09-30
First Post:
2010-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concentration-controlled Therapy of Mycophenolate Mofetil (MMF) in 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'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-27', 'studyFirstSubmitDate': '2010-01-04', 'studyFirstSubmitQcDate': '2010-01-04', 'lastUpdatePostDateStruct': {'date': '2013-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate of Mycophenolic acid concentration-controlled therapy in active lupus nephritis patients at 6th month', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'To determine Mycophenolic acid level related side effect.', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['trough level', 'therapeutic drug monitoring', 'Mycophenolate mofetil', 'Mycophenolic acid', 'lupus nephritis'], 'conditions': ['Lupus Nephritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lupus.research.chula.ac.th/', 'label': '(Lupus Research Unit)'}]}, 'descriptionModule': {'briefSummary': 'To evaluate therapeutic response to MMF treatment in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis. Mycophenolic acid levels at 1-hour post dose will be monitored monthly up to 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 16-60 years.\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\nExclusion Criteria:\n\nRelates to SLE\n\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\nRelated to Treatment\n\n* Previous of any Mycophenolate groups in the 3 months prior to screening.\n* Treatment with more than 2 g Cyclophosphamide in the last 6 months period prior to screening.\n* Receipt of more than 3 g IV pulse methylprednisolone within the last 3 months prior to screening.\n* Receipt of prednisolone dose \\> 30 mg/day for longer than 30 days within last 3 months prior to screening.\n\nRelated to General Health\n\n* Pregnancy or breast feeding mothers.\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* History of serious recurrent or chronic infection.\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': 'NCT01042457', 'briefTitle': 'Concentration-controlled Therapy of Mycophenolate Mofetil (MMF) in Proliferative Lupus Nephritis', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'orgStudyIdInfo': {'id': '2009-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Mycophenolate mofetil', 'interventionNames': ['Drug: Mycophenolate mofetil']}], 'interventions': [{'name': 'Mycophenolate mofetil', 'type': 'DRUG', 'otherNames': ['cellcept'], 'description': 'Drug : Mycophenolate Mofetil. Starting doses : 1000-1500 mg/day with titration based on Mycophenolic 1-hour post dose level.', 'armGroupLabels': ['Mycophenolate mofetil']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Chulalongkorn University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Yingyos Avihingsanon, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chulalongkorn University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}