[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100369808":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":10,"centralContacts":28,"locations":34,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":10,"enrollmentInfo":67,"targetDuration":10,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Mario Negri Institute for Pharmacological Research","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Prospective cohort",null,"Patients with biopsy-proven idiopathic MN, who are candidate to receive a B-cell depleting treatment as per center clinical practice.",[13],"Diagnostic Test: In vitro assays.",{"label":15,"type":10,"description":16,"interventionNames":17},"Retrospective cohort","Patients with biopsy-proven idiopathic MN, who already received a B-cell depleting treatment as per center clinical practice.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Healthy volunteers cohort","Subjects \\> 18 years not known to suffer of any significant illness, not assuming any medication or drug on a regular basis.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DIAGNOSTIC_TEST","In vitro assays.","Biochemical and flow-cytometry analysis of specimen collected.",[19,9,15],[29],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Manuel Podestà, MD","CONTACT","003903545351","manuel.podesta@guest.marionegri.it",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Centro di Ricerche Cliniche per le Malattie Rare \" Aldo e Cele Daccò\"","RECRUITING","Ranica","BG","24020","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],9.71335,45.72328,{"lat":47,"lon":46},[50],{"name":51,"role":31,"phone":52,"phoneExt":10,"email":53},"Manuel Podesta, MD","0039 035 45351","Manuel.podesta@guest.marionegri.it",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100369808","autoreactive-b-cells-in-membranous-nephropathy-100369808",false,"NCT04095156","Autoreactive B Cells in Membranous Nephropathy","PLA2R Autoreactive B-Cell Subsets and Immune Cell Monitoring in Membranous Nephropathy: Identification of Outcome Predictors and Novel Insights Into Disease Pathogenesis","PEPTIDE","Inclusion Criteria:\n\nPatients inclusion criteria\n\n* Males and females.\n* Adults (\\> 18 years old).\n* Patients with biopsy-proven idiopathic MN, who are candidate to receive (prospective cohort) or who already received (retrospective cohort) a B-cell depleting treatment as per center clinical practice.\n* Mental state is such that they are able to understand and give valid consent to the study;\n* Written informed consent according to the guidelines of the Declaration of Helsinki.\n\nHealthy volunteers inclusion criteria\n\n* Male and female (\\>18 years) not known to suffer of any significant illness;\n* Not assuming any medication or drug on a regular basis;\n* Negative urine analysis (urine dipstick, multistick);\n* Written informed consent according to the guidelines of the Declaration of Helsinki\n\nExclusion Criteria:\n\nPatients exclusion criteria\n\n* Reasonable possibility of a secondary cause of MN (e.g.systemic lupus erythematosus, active hepatitis B, malignancy, drugs such as gold salts and penicillamine).\n* Legal incapacity, intellectual disability\u002Fmental retardation, dementia, uncooperative attitude or any other evidence that patient will not be able to understand the study procedures and aims and to give written informed consent.\n\nHealthy volunteers exclusion criteria\n\n\\- Legal incapacity, intellectual disability\u002Fmental retardation, dementia, uncooperative attitude or any other evidence that patient will not be able to understand the study procedures and aims and to give written informed consent.",true,"ALL","18 Years",{"count":68,"type":69},86,"ESTIMATED","OBSERVATIONAL","Membranous nephropathy (MN) is the most frequent cause of nephrotic syndrome (NS) in adults. The majority of MN patients show detectable circulating antibodies against the M-type phospholipase A2 receptor (PLA2R). Infusion of anti-CD20 monoclonal antibodies results in a profound depletion of B-cells, which are thought to be responsible for anti-PLA2R production. B-cell depletion is followed by NS remission in 70% of cases. Limited evidence highlighted that differences in the B- and T-cell compartments may exist between responders and non-responders. Owing to the non-homogenous efficacy of anti-CD20 treatment, investigators hypothesize that in MN patients who experience NS remission after B-cell depleting therapy, autoreactive B-cells may be mostly circulating, whereas in patients who do not respond to the same treatment, autoreactive B-cells may chiefly reside into secondary lymphoid organs - and thus be more resistant to the drug action. Researchers will therefore extensively analyze the circulating immune repertoire of MN patients before and after the infusion of B-cell lineage depleting agents, assessing the presence of circulating PLA2R autoreactive B cells from appropriately stratified responder and non-responder patients. Patients and healthy controls will be enrolled in this study. Patients will be stratified according to gender, anti-PLA2R status, type of B-cell lineage depleting agent received and response to treatment.",[73],"Membranous Nephropathy",[75,76,77,78],"Membranous nephropathy","B cells","Anti-PLA2R","Anti-CD20 antibodies","2026-03-19",{"date":81,"type":82},"2026-03-20","ACTUAL",{"date":84,"type":82},"2019-09-25",{"date":86,"type":69},"2026-11",{"name":5,"class":6},1]