[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565455":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":43,"centralContacts":48,"locations":57,"responsibleParty":108,"collaborators":110,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":10,"eligibilityCriteria":121,"healthyVolunteers":122,"sex":123,"minAge":124,"maxAge":10,"enrollmentInfo":125,"targetDuration":128,"studyType":129,"phases":10,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":88,"whyStopped":10,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Kolding Sygehus","OTHER",[8,16,20,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Systemic lupus erythomatosus with lupus nephritis",null,"SLE patients with kidney involvement",[13,14,15],"Diagnostic Test: Kidney biopsy","Diagnostic Test: Urinary extracellular vesicle testing","Diagnostic Test: Autoimmunity in plasma",{"label":17,"type":10,"description":18,"interventionNames":19},"Systemic lupus erythomatosus without lupus nephritis","SLE patients, fulfilling the 2019 EULAR\u002FACR classification criteria with no sign of kidney disease",[14,15],{"label":21,"type":10,"description":21,"interventionNames":22},"Healthy controls",[14],{"label":24,"type":10,"description":25,"interventionNames":26},"Biopsy controls","A biopsy control group with no predictive complement activation referred to biopsy",[13,14],[28,35,39],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DIAGNOSTIC_TEST","Kidney biopsy","Patient refered to kidney biopsy independent of the presented study",[24,9],[34],"No expected complement activation",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":10},"Urinary extracellular vesicle testing","Urinary extracellular vesicles will be isolated and tested for complement activation and other markers of kidney disease",[24,21,9,17],{"type":29,"name":40,"description":41,"armGroupLabels":42,"otherNames":10},"Autoimmunity in plasma","Expected autoimmunity in plasma isolated from blood samples",[9,17],[44],{"name":45,"affiliation":46,"role":47},"Anne F Christensen, Chief of Medicine, MD, phd","Sygehus Lillebaelt, Kolding Hospitl","STUDY_CHAIR",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":10,"email":53},"Rikke Z Langkilde, MD, phd","CONTACT","4530281347","rikke.zachar.langkilde@rsyd.dk",{"name":55,"role":51,"phone":10,"phoneExt":10,"email":56},"Anne D Thuesen, MD, phd, clinical lector","anne.daugaard.thuesen2@rsyd.dk",[58,74,86,97],{"facility":59,"status":60,"city":61,"state":10,"zip":10,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Kolding Hospital","NOT_YET_RECRUITING","Kolding","Denmark","DK",{"type":65,"coordinates":66},"Point",[67,68],9.47216,55.4904,{"lat":68,"lon":67},[71],{"name":72,"role":51,"phone":73,"phoneExt":10,"email":56},"Anne D Thuesen, Head of research, MD, phd","004576360555",{"facility":75,"status":60,"city":76,"state":10,"zip":77,"country":62,"countryCode":63,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Department of Nephrology","Odense","5000",{"type":65,"coordinates":79},[80,81],10.38831,55.39594,{"lat":81,"lon":80},[84],{"name":85,"role":51,"phone":10,"phoneExt":10,"email":10},"michael Aarup, MD, consultant",{"facility":87,"status":88,"city":76,"state":10,"zip":77,"country":62,"countryCode":63,"cosmosGeoPoint":89,"geoPoint":91,"contacts":92},"Department of Rheumatology","RECRUITING",{"type":65,"coordinates":90},[80,81],{"lat":81,"lon":80},[93],{"name":94,"role":51,"phone":95,"phoneExt":10,"email":96},"Henrik Z Langkilde, MD","21279653","henrik.zachar.langkilde@rsyd.dk",{"facility":98,"status":60,"city":76,"state":10,"zip":99,"country":62,"countryCode":63,"cosmosGeoPoint":100,"geoPoint":102,"contacts":103},"Univesity of Southern Denmark","5230",{"type":65,"coordinates":101},[80,81],{"lat":81,"lon":80},[104],{"name":105,"role":51,"phone":106,"phoneExt":10,"email":107},"Per Svenningsen, professor","004565501000","psvenningsen@health.sdu.dk",{"type":109,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[111,113],{"name":112,"class":6},"University of Southern Denmark",{"name":114,"class":6},"Odense University Hospital","100565455","monitoring-lupus-nephritis-through-urinary-extracellular-vesicles-100565455",false,"NCT06642402","Monitoring Lupus Nephritis Through Urinary Extracellular Vesicles","Monitoring and Detecting Lupus Nephritis Through Urinary Extracellular Vesicles in Urine","SLE patients with kidney involvement\n\nInclusion criteria:\n\n* \\> 18 years old\n* Fulfilling the 2019 EULAR\u002FACR classification criteria\n* Positive autoantibodies, medical history and obejctive examination compatible with SLE\n* Referred to kidney biopsy\n\nExclusion criteria:\n\n* Lack of ability or willingness to provide informed consent\n* Significant comorbidity, which is considered to potentially impact the outcome\n\nSLE patients with no sign of kidney disease\n\nInclusion criteria:\n\n* \\> 18 years old\n* Fulfilling the 2019 EULAR\u002FACR classification criteria\n* Positive autoantibodies, medical history and obejctive examination compatible with SLE\n* Normal plasma creatinine\n* Urine albumine\u002Fcreatinine \\\u003C 100 mg\u002Fg\n\nExclusion criteria:\n\n* Lack of ability or willingness to provide informed consent\n* Significant comorbidity, which is considered to potentially impact the outcome\n\nHealthy controls:\n\nInclusion criteria:\n\n* \\> 18 years old\n* No known kidney disease\n\nExclusion criteria:\n\n* Lack of ability or willingness to provide informed consent\n* Urine albumin-creatinine ratio \\> 100 mg\u002Fg or proteinuria \\> 100 mg\u002Fday\n* Postive autoantibodies\n* Significant comorbidity, which is considered to potentially impact the outcome\n\nBiopsy control:\n\nInclusion criteria:\n\n* \\> 18 years old\n* Negative autoantibiodies and immunoglobulines\n* Referred to kidney biopsy\n\nExclusion criteria:\n\n* Lack of ability or willingness to provide informed consent\n* Significant comorbidity, which is considered to potentially impact the outcome",true,"ALL","18 Years",{"count":126,"type":127},40,"ESTIMATED","1 Year","OBSERVATIONAL","Lupus nephritis (LN) is a severe manifestation of systemic lupus erythematosus (SLE) that can lead to irreversible kidney damage if not detected and managed promptly. LN is classified and treated based on its histopathological features obtained by invasive kidney biopsy. Recent research has suggested urinary extracellular vesicles (uEVs) as potential non-invasive biomarkers. The primary objective of this prospective study is to investigate the utility of uEVs in LN.",[132],"Systemic Lupus Erythematosus Nephritis",[134,135,136,137],"Systemic Lupus Erythoematosus nephritis","Lupus nephritis","complement activation","kidney biopsy","2025-09-02",{"date":140,"type":141},"2025-09-09","ACTUAL",{"date":143,"type":141},"2024-11-15",{"date":145,"type":127},"2030-05-01",{"name":5,"class":6},4]