Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-02-25 @ 8:25 PM
Study NCT ID:
NCT02256150
Status:
COMPLETED
Last Update Posted:
2019-06-07
First Post:
2014-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of 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': 'C010052', 'term': 'mizoribine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'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': 'D009930', 'term': 'Organic Chemicals'}, {'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': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-05', 'studyFirstSubmitDate': '2014-10-01', 'studyFirstSubmitQcDate': '2014-10-01', 'lastUpdatePostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Remission rate', 'timeFrame': '52 weeks'}], 'secondaryOutcomes': [{'measure': 'Complete Remission rate', 'timeFrame': '52 weeks'}, {'measure': 'Partial Remission rate', 'timeFrame': '52 weeks'}, {'measure': 'Changes of Overall Remission rate', 'timeFrame': '8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks'}, {'measure': 'Changes of Complete Remission rate', 'timeFrame': '8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks'}, {'measure': 'Changes of partial remission rate', 'timeFrame': '8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks'}, {'measure': 'Treatment failure rate', 'timeFrame': '52 weeks'}, {'measure': 'Changes and percentage change of 24 hours urine protein and serum albumin from the baseline', 'timeFrame': '8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks'}, {'measure': 'Changes of and percentage change of SCr, eGFR and BUN from the baseline', 'timeFrame': '8 weeks, 20 weeks, 32 weeks, 44 weeks and 52 weeks'}, {'measure': 'Changes of immunological test (C3, Anti-DNA antibody, ANA, Anti-Sm antibody and Anti-phospholipid antibody) from baseline', 'timeFrame': '20 weeks and 52 weeks'}, {'measure': 'Changes of SLE-DAI score from baseline', 'timeFrame': '20 weeks and 52 weeks'}, {'measure': 'Progression to End-Stage Renal Disease or Doubling of SCr through the study.', 'timeFrame': '52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lupus Nephritis']}, 'referencesModule': {'references': [{'pmid': '40085084', 'type': 'DERIVED', 'citation': 'Dong Z, Luo P, Sun S, Ni Z, He Y, Huang X, Liu Z, Wu Z, Zhang X, Liao Y, Zhao J, Lin H, Zhang X, Fu R, Ding G, Xu Y, Wang L, Xiao Y, Shi S, Zuo X, Li Z, Qiao L, Wang R, Li W, Wan J, Li Y, Guan T, Deng X, Wu X, Zheng H, Chen J, He L, Yamaguchi S, Wang H, Cai GY, Zhang L, Chen X. Mizoribine or Cyclophosphamide for Lupus Nephritis: A Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e250648. doi: 10.1001/jamanetworkopen.2025.0648.'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate that the treatment effect in lupus nephritis of MZR is non-inferior to that of standard therapy CTX through analyzing overall remission rate after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has been diagnosed with SLE according to American College of Rheumatology (ACR) criteria in 1997;\n* Patient who has had a kidney biopsy within 365 days prior to screening which was confirmed as class III, III+V, IV, IV+V, or V according to the pathologic classification of International Society of Nephrology/Renal Pathology Society (ISN/RPS) in 2003;\n* Patient with 24hr-urine protein ≥ 1.0g;\n* SLE-DAI \\> 8 ;\n* Male or female patient between 18 and 70 years (inclusive) at informed consent obtained date;\n* Patient with body weight between 40kg and 80kg (inclusive) at screening;\n* Patients who sign the informed consent form;\n\nExclusion Criteria:\n\n* Patient who had history of allergy to any investigational product (MZR, CTX) or hormone;\n* Patient who had received accumulated dosage of CTX \\>3g within one year prior to screening.\n* Patient who had received immunosuppressant or Chinese traditional medicine with immunosuppressive effect within 30 days prior to screening;\n* Patient who had received prednisone\\>1.0mg/kg/day or equivalent dose of other oral glucocorticoid therapies within 30 days prior to screening;\n* Patient who received other investigational drugs within 30 days prior to screening;\n* Patient who have received plasma exchange therapy or immunoadsorption therapy within 30 days prior to screening;\n* Patient who require pentostatin or live vaccine (not including flu vaccine);\n* Patient who is undergoing renal replacement therapy;\n* Patient who received kidney transplantation;\n* Patient with malignancy;\n* Patient with severe hypertension (SBP \\> 160mmHg or DBP \\> 100mmHg) which has not been effectively controlled;\n* Patient with white blood cell count \\<3×109/L /L(=3.0 GI/L);\n* Patient with SCr \\> 176.8μmol/L;\n* Patient who has a value that is \\> 3 times of the upper limit of normal range for AST or ALT;\n* Patient with hepatitis B, hepatitis C or HIV infection;\n* Patient with other serious infections;\n* Patient who is unsuitable for participating in this study in the opinion of investigators ( e.g. uncontrolled diabetes, central nervous system lupus , lupus encephalopathy, active psychosis,osteonecrosis of the femoral head, fulminant hepatitis, peptic ulcer, etc.);\n* Female patient who is pregnant, currently breast feeding or willing to become pregnant;\n* Patient with any other diseases that would affect the evaluation of efficacy or safety.'}, 'identificationModule': {'nctId': 'NCT02256150', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Lupus Nephritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Asahi Kasei Pharma Corporation'}, 'officialTitle': 'A Multi-center, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of Mizoribine in Comparison With Cyclophosphamide in the Treatment of Lupus Nephritis', 'orgStudyIdInfo': {'id': 'HE-69-C-Lu-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mizoribine (MZR)', 'description': 'Oral administration, daily dose of 150mg (50mg/tablet, t.i.d) All study subjects will receive standard steroid therapies during the study.', 'interventionNames': ['Drug: Mizoribine (MZR)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cyclophosphamide (CTX)', 'description': 'Intravenous injection with between 0.5 to 1.0 g/m2 body surface area each time (the maximum dose is 1.0 g/day each time).\n\nAll study subjects will receive standard steroid therapies during the study.', 'interventionNames': ['Drug: Cyclophosphamide (CTX)']}], 'interventions': [{'name': 'Mizoribine (MZR)', 'type': 'DRUG', 'otherNames': ['HE-69'], 'armGroupLabels': ['Mizoribine (MZR)']}, {'name': 'Cyclophosphamide (CTX)', 'type': 'DRUG', 'armGroupLabels': ['Cyclophosphamide (CTX)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'The Third Affiliated Hospital of the Third Military Medical University (Daping Hospital)', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'The first Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guilin', 'state': 'Guangxi', 'country': 'China', 'facility': 'Affiliated Hospital of Guilin Medical University', 'geoPoint': {'lat': 25.28022, 'lon': 110.29639}}, {'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'The First Affiliated Hospital of Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'The Third Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Renmin Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Zhongnan Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuxi', 'state': 'Jiangsu', 'country': 'China', 'facility': "Wuxi People's Hospital", 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'The Second Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'facility': 'The First Affiliated Hospital of Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'The General Hospital of Shenyang Military Region', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Shandong Provincial Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'The General Hospital of Jinan Military Region', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Qingdao', 'state': 'Shandong', 'country': 'China', 'facility': 'The Affilited Hospital of Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Renji Hospital Shanghai Jiaotong University School of Medical', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'The Second Hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Xian', 'state': 'Shanxi', 'country': 'China', 'facility': 'The First Affiliated Hospital of the Fourth Military Medical University (Xijing Hospital)'}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': 'Kuming General Hospital of Chengdu Military Region', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital of College of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Asahi Kasei Pharma Corporation', 'role': 'STUDY_CHAIR', 'affiliation': 'Asahi Kasei Pharma Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asahi Kasei Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}