[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605522":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":34,"responsibleParty":51,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":11,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":11,"enrollmentInfo":66,"targetDuration":11,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":37,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment with obinutuzumab.","EXPERIMENTAL",null,[13],"Drug: Obinutuzumab administration",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Obinutuzumab administration","All participants will receive obinutuzumab 1000 mg on day 1 and 15, with two additional infusions after 6 months if the anti-PLA2R antibody IFT assay is still positive with proteinuria \\> 2 gram\u002F24 hours and stable kidney function.",[9],[21],{"name":22,"affiliation":5,"role":23},"Anne-Els Van de Logt, M.D., PhD","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},"Ruben Visch, M.D.","CONTACT","+31 (0)24 3092575","ruben.visch@radboudumc.nl",{"name":31,"role":27,"phone":32,"phoneExt":11,"email":33},"Anne-Els van de logt, M.D., PhD","+31611167560","anne-els.vandelogt@radboudumc.nl",[35],{"facility":36,"status":37,"city":38,"state":11,"zip":11,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Department of Nephrology, Radboud University Medical Center","RECRUITING","Nijmegen","Netherlands","NL",{"type":42,"coordinates":43},"Point",[44,45],5.85278,51.8425,{"lat":45,"lon":44},[48,49,50],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},{"name":31,"role":27,"phone":11,"phoneExt":11,"email":33},{"name":22,"role":23,"phone":11,"phoneExt":11,"email":11},{"type":52,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[54],{"name":55,"class":56},"Hoffmann-La Roche","INDUSTRY","100605522","phase-2-obinutuzumab-induced-decreases-of-pla2r-antibodies-in-membranous-nephropathy-a-pilot-study-100605522",false,"NCT07163611","Obinutuzumab Induced Decreases of PLA2R Antibodies in Membranous Nephropathy: a Pilot Study","Obinutuzumab Induced Decreases of PLA2Rab in MN: a Pilot Study","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Diagnosis of PMN, confirmed by:\n\n  1. Kidney biopsy or\n  2. Positive serum PLA2Rab test either by IFT and\u002For ELISA)\n* Serum PLA2Rab titer \\> 80 RU\u002Fml\n* Proteinuria ≥ 3.5 g\u002F24h despite supportive treatment for at least 6 months with a maximally tolerated and stable dose of ACE-i or ARB.\n* Serum albumin \\\u003C 30 g\u002Fl measured by BCP assay.\n* eGFR ≥ 30 ml\u002Fmin\u002F1.73m2.\n* Treatment with immunosuppression is warranted, as determined by the treating physician.\n\nExclusion Criteria:\n\n* Secondary MN (e.g., hepatitis B or C infection, human immunodeficiency virus infection, active infection, systemic lupus erythematosus, sarcoidosis, IgG4-related, drug-induced, malignancy).\n* RTX within 12 months prior to inclusion.\n* CNI within 2 months prior to inclusion.\n* Treatment with other immunosuppressive drugs within 6 months prior to inclusion.\n* Proteinuria must not have decreased by \\> 50% over 6 months whilst taking ACEi\u002FARB.\n* Life-threatening nephrotic syndrome resistant to treatment.\n* \\> 20% increase in serum creatinine not otherwise explained during antiproteinuric supportive treatment.\n* Pregnancy or breastfeeding. Women of childbearing age and male patients with female partners of childbearing potential not willing to use contraception throughout the study and for at least 6 months after the last dose of obinutuzumab.\n* Suspected or known hypersensitivity, allergy, and\u002For immunogenic reaction history to monoclonal antibodies, corticosteroid, cyclophosphamide, any of their ingredients, and any other drugs from these same pharmacotherapeutic groups.\n* Known active infection of any kind or recent major episode of infection.\n* Any disorder or condition which might pose an unacceptable risk to patient's safety and well-being that might interfere with completion of the study.\n* Inability to understand or comply with the requirements of the study.\n* Incapable of recognizing the nature, significance, and scope of the clinical trial or giving consent even with a legal representative.\n* Use of an investigational agent.","ALL","18 Years",{"count":67,"type":68},20,"ESTIMATED","INTERVENTIONAL",[71,72],"PHASE2","PHASE3","Objective: To assess the disappearance rate (half-life) of anti-PLA2R antibodies in high-risk primary membranous nephropathy (pMN) patients treated with obinutuzumab (OBI), and to evaluate immunological and clinical remission, adverse events, and quality of life.\n\nDesign: Open-label, single-center, prospective pilot intervention study conducted at Radboud University Medical Center.\n\nPopulation: 20 adult patients with high-risk PMN, defined by proteinuria ≥3.5 g\u002F24h despite 6 months of supportive treatment with ACE inhibitors or ARBs.\n\nIntervention: OBI 1000 mg on days 1 and 15, with two additional infusions after 6 months if anti-PLA2R antibody levels remain positive and proteinuria exceeds 2 g\u002F24h.\n\nFollow-up: Patients were monitored at baseline, and at weeks 1, 2, 4, 8, 12, 24, 37, and 52.",[75],"Membranous Nephropathy - PLA2R Induced",[77,78,79],"PLA2R antibody kinetics","membranous nephropathy","obinutuzumab","2025-12-31",{"date":82,"type":83},"2026-01-06","ACTUAL",{"date":85,"type":83},"2025-10-01",{"date":87,"type":68},"2028-04-01",{"name":5,"class":6},1]