Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-03-09 @ 9:48 AM
Study NCT ID:
NCT03920059
Status:
TERMINATED
Last Update Posted:
2021-02-01
First Post:
2019-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active 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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Slow recruitment rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-27', 'studyFirstSubmitDate': '2019-04-01', 'studyFirstSubmitQcDate': '2019-04-17', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate at 48 week of therapy', 'timeFrame': '48 weeks'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '48 weeks'}, {'measure': 'Mycophenolic acid trough levels', 'timeFrame': '48 weeks'}, {'measure': 'MPA-area under the curve (AUC) 0-4 hour at 12 week', 'timeFrame': '12 weeks'}, {'measure': 'C3 levels', 'timeFrame': '48 weeks'}, {'measure': 'Urine IP-10 levels', 'timeFrame': '48 weeks'}, {'measure': 'Anti-dsDNA', 'timeFrame': '48 weeks'}, {'measure': 'Relapse free survival at 96, 144 and 240 week', 'timeFrame': '96, 144 and 240 weeks'}, {'measure': 'eGFR at 96, 144 and 240 week', 'timeFrame': '96, 144 and 240 weeks'}, {'measure': 'Progression to CKD stage 3 or more at 96, 144 and 240 week', 'timeFrame': '96, 144 and 240 weeks'}, {'measure': 'End stage renal disease at 96, 144 and 240 week', 'timeFrame': '96, 144 and 240 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lupus Nephritis']}, 'descriptionModule': {'briefSummary': 'A randomized open-label study of fixed-dose versus concentration-controlled mycophenolate mofetil for treatment of active lupus nephritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 year\n* Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE\n* Active lupus nephritis (both new and flare patients can be included) defined as:\n\n * Within 16 weeks of randomization, had Biopsy-proven ISN class III or IV \\[exclude III(c), IV-S(c) and IV-G(c). Patients are permitted to have co-existing class V and\n * At screening day, has urine protein creatinine ratio (UPCR) or 24-hour urinary protein ≥ 1.0 g/g or g/day\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding\n* Child-bearing age women who refuse to use effective birth-control\n* Poor compliance\n* Estimated-GFR \\< 20 mL/min/1.73 m2\n* Crescentic glomeruli more than 30 percent\n* Severe extra-renal involvement of SLE\n* History of severe allergic reactions or adverse effects to MMF\n* Uncontrolled concomitant disease\n* Known active, clinically significant infection of any kind\n* History of serious recurrent or chronic infection\n* History of malignancy (except basal cell carcinoma, squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been excised and cured)\n* Concomitant conditions which has required treatment with systemic corticosteroid (excluding topical or inhaled steroids) at any time in the 52 weeks prior to screening\n* Treatment with more than 1 g cyclophosphamide within the past 24 weeks\n* Receipt more than 3 g of IV pulse methylprednisolone within the past 12 weeks\n* Receipt prednisolone more than 30 mg/day for longer than 30 days within the past 12 weeks\n* Treatment with MMF at ≥ 1.5 g/day for over 4 weeks within the past 12 weeks\n* On treatment with Tacrolimus or Cyclosporine on the day of screening\n* Treatment with any biologic B-cell depleting therapy (e.g. anti CD-20, anti CD 22) within 52 weeks\n* Receiving concomitant medication interfering PK of MPA\n\n * Cholestyramine\n * Rifampin'}, 'identificationModule': {'nctId': 'NCT03920059', 'briefTitle': 'Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'A Randomized Open-label Study of Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis', 'orgStudyIdInfo': {'id': 'FDCC lupus'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'FD arm', 'description': 'MMF will be prescribed at a starting dose of 1.5 g/day and increased to 2 g/day at week 4 (if body weight ≥ 45 kg) and continue the same dose until week 24. After week 24, MMF will be lowered to 1.5 g/day.', 'interventionNames': ['Drug: Mycophenolate Mofetil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CC Arm', 'description': 'MMF will be prescribed at a starting dose of 1.5 g/day. MPA-C0 (trough) level will be measured weekly and MMF dose will be increased by 500 mg/day every week until the MPA-C0 level ≥ 3 mg/L or the MMF dosage is 3000 mg/day. After achieving the targeted MPA-C0 level, the MMF dose adjustment will be allowed only if the MPA-C0 levels are lower than 3 mg/L for two consecutive monitoring visits. After week 12, MMF will be maintained at the same dose until week 48', 'interventionNames': ['Drug: Mycophenolate Mofetil']}], 'interventions': [{'name': 'Mycophenolate Mofetil', 'type': 'DRUG', 'description': 'Description Each capsule contains Mycophenolate mofetil 250 mg. Presentation / Packing Cap 250 mg (white to off white powder, light blue/peach hard gelatin, imprinting with "MMF" on cap and "250" on body) x 10 x 10\'s.\n\nStorage Store below 30 degree Celcius.', 'armGroupLabels': ['CC Arm', 'FD arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'state': 'Please Select', 'country': 'Thailand', 'facility': 'King Chulalongkorn Memorial Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Berlin Pharmaceutical Industry', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yingyos Avihingsanon', 'investigatorAffiliation': 'Chulalongkorn University'}}}}