[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597084":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":29,"armGroups":25,"interventions":30,"overallOfficials":25,"centralContacts":35,"locations":41,"responsibleParty":58,"collaborators":25,"id":60,"slug":25,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":25,"eligibilityCriteria":64,"healthyVolunteers":61,"sex":65,"minAge":66,"maxAge":25,"enrollmentInfo":67,"targetDuration":25,"studyType":70,"phases":25,"briefSummary":71,"conditions":72,"keywords":25,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Otsuka Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":25},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"Safety Information (Number of Adverse Event)","Any untoward medicinal occurrence in a patient or clinical study subject administered a Medicinal Product and which does not necessarily have a causal relationship with this treatment (ICH-E2A Guideline). An Adverse Event can therefore be any unfavorable and unintended sign (e.g. abnormal laboratory finding), symptom, or disease temporally associated with the use of a Medicinal Product (LUPKYNIS), whether or not it is considered causally related to the Medicinal Product.","3 years from the initiation of LUPKYNIS treatment",{"measure":14,"description":15,"timeFrame":12},"Safety Information (Types of Special Situations and the Number of Corresponding Cases)","Situations related to the use of an Otsuka product which may or may not be associated with an adverse event:\n\n* Maternal (pregnancy and breastfeeding) or paternal (via semen) exposure;\n* Exposure during breastfeeding;\n* Overdose\u002FIncorrect dosage, misuse, abuse (e.g. patient sharing products); -Medication errors (e.g. patient took wrong dose);\n* Lack of therapeutic efficacy (e.g. the product doesn't work);\n* Occupational exposure (e.g.: nurse administering the product is exposed);\n* Cases of suspected transmission of infectious agents;\n* Use of suspected or confirmed falsified product(s) or quality defect of the product(s);\n* Withdrawal reactions; -Accidental exposure (e.g.: child takes parent's product);\n* Drug-drug\u002Fdrug-food interactions;\n* Unintentional use of product in a non-approved population (e.g.: pediatric or geriatric population);\n* Disease progression\u002Fexacerbation of existing disease.",{"measure":17,"description":18,"timeFrame":12},"Safety Information (Number of off-Label Use)","Collecting any type of off-Label Use that refers to situations where a product is intentionally used for a medical purpose not in accordance with the authorized product information. Off-label use also includes the intentional use in non-authorized population categories not indicated in the label.",{"measure":20,"description":21,"timeFrame":12},"Safety Information (Number of Serious Adverse Event)","Any adverse drug experience\u002Fevent occurring at any dose which\n\n* results in death\n* is life-threatening\n* requires inpatient hospitalization or prolonged of existing hospitalization\n* results in persistent or significant disability or incapacity\n* is a congenital anomaly\u002Fbirth defect\n* is medically significant.",{"measure":23,"description":24,"timeFrame":12},"Safety Information (Number of Non-serious Adverse Events)","All Adverse Events that do not meet the definition of a serious Adverse Event are considered non-serious Adverse Events.",null,{"allocation":25,"interventionModel":25,"interventionModelDescription":25,"primaryPurpose":25,"observationalModel":27,"timePerspective":28,"maskingInfo":25},"COHORT","PROSPECTIVE","Patients in Japan who are planned to be newly started on LUPKYNIS for lupus nephritis.",[31],{"type":32,"name":33,"description":34,"armGroupLabels":25,"otherNames":25},"DRUG","Voclosporin (LUPKYNIS)","In general, for adults, voclosporin should be administered orally at a dose of 23.7 mg BID. The dosage may be appropriately reduced depending on the patient's condition. In principle, at the start of treatment with voclosporin, it should be used in combination with corticosteroids and mycophenolate mofetil.",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd","CONTACT","+81-6-6943-7722","komaniwa.satoshi@otsuka.jp",[42],{"facility":43,"status":44,"city":45,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Pharmacovigilance Department","RECRUITING","Osaka","540-0021","Japan","JP",{"type":50,"coordinates":51},"Point",[52,53],135.50107,34.69379,{"lat":53,"lon":52},[56],{"name":57,"role":38,"phone":39,"phoneExt":25,"email":40},"Study Director",{"type":59,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100597084",false,"NCT07053891","LUPKYNIS Drug-use Results Survey","Inclusion Criteria:\n\n* Patients who are newly starting administration of LUPKYNIS for lupus nephritis\n\nExclusion Criteria:\n\n\\-","ALL","15 Years",{"count":68,"type":69},400,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to survey the safety of LUPKYNIS in patients with lupus nephritis under actual use conditions. In addition, information on efficacy will be collected.",[73],"Lupus Nephritis","2025-09-18",{"date":76,"type":77},"2025-09-19","ACTUAL",{"date":79,"type":77},"2025-09-17",{"date":81,"type":69},"2032-06-30",{"name":5,"class":6},1]