[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647538":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":38,"responsibleParty":140,"collaborators":142,"id":153,"slug":154,"hasResults":155,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":155,"sex":161,"minAge":162,"maxAge":11,"enrollmentInfo":163,"targetDuration":11,"studyType":166,"phases":167,"briefSummary":169,"conditions":170,"keywords":11,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},{"fullName":5,"class":6},"Medical University Innsbruck","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Obinutuzumab","EXPERIMENTAL",null,[13],"Drug: Obinutuzumab Injection",{"label":15,"type":16,"description":11,"interventionNames":17},"Glucocorticoids","ACTIVE_COMPARATOR",[18],"Drug: Predniso(lo)ne",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Obinutuzumab Injection","Obinutuzumab (2-times, 1 g each) will be administered",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Predniso(lo)ne","Predniso(lo)ne will be used as the active comparator, with a planned withdrawal after 6 months",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Andreas Kronbichler, M.D. Ph.D.","CONTACT","004351250425855","andreas.kronbichler@i-med.ac.at",{"name":36,"role":32,"phone":11,"phoneExt":11,"email":37},"Philipp Gauckler, M.D.","philipp.gauckler@i-med.ac.at",[39,59,73,90,109,123],{"facility":40,"status":41,"city":42,"state":11,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Division of Nephrology, Department of Internal Medicine, Medical University of Graz","RECRUITING","Graz","8036","Austria","AT",{"type":47,"coordinates":48},"Point",[49,50],15.44197,47.06733,{"lat":50,"lon":49},[53,57],{"name":54,"role":32,"phone":55,"phoneExt":11,"email":56},"Max Schuller, M.D. Ph.D.","004331638512170","max.schuller@medunigraz.at",{"name":58,"role":32,"phone":11,"phoneExt":11,"email":11},"Kathrin Eller, M.D. Ph.D.",{"facility":60,"status":41,"city":61,"state":11,"zip":62,"country":44,"countryCode":45,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Department of Internal Medicine IV, Nephrology and Hypertension","Innsbruck","6020",{"type":47,"coordinates":64},[65,66],11.39454,47.26266,{"lat":66,"lon":65},[69,70,71],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},{"name":36,"role":32,"phone":11,"phoneExt":11,"email":37},{"name":31,"role":72,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"facility":74,"status":75,"city":76,"state":11,"zip":77,"country":44,"countryCode":45,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"6. Medizinische Abteilung mit Nephrologie & Dialyse, Klinik Ottakring","NOT_YET_RECRUITING","Vienna","1160",{"type":47,"coordinates":79},[80,81],16.37208,48.20849,{"lat":81,"lon":80},[84,88],{"name":85,"role":32,"phone":86,"phoneExt":11,"email":87},"Sara Ksiazek, M.D.","00431491502610","sara.ksiazek@hotmail.com",{"name":89,"role":32,"phone":11,"phoneExt":11,"email":11},"Marcus Säemann, M.D.",{"facility":91,"status":75,"city":92,"state":11,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Laboratory of Immunology, Nice University Hospital (CHU de Nice), Côte d'Azur University","Nice","06003","France","FR",{"type":47,"coordinates":97},[98,99],7.26608,43.70313,{"lat":99,"lon":98},[102,106],{"name":103,"role":32,"phone":104,"phoneExt":11,"email":105},"Barbara Seitz-Polski, M.D. Ph.D.","0033492037917","seitz-polski.b@chu-nice.fr",{"name":107,"role":32,"phone":11,"phoneExt":11,"email":108},"Celine Fernandez, M.D.","fernandez.c3@chu-nice.fr",{"facility":110,"status":75,"city":111,"state":11,"zip":112,"country":94,"countryCode":95,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Hôpital Henri-Mondor","Paris","94000",{"type":47,"coordinates":114},[115,116],2.3488,48.85341,{"lat":116,"lon":115},[119],{"name":120,"role":32,"phone":121,"phoneExt":11,"email":122},"Vincent Audard, M.D.","0033149812457","vincent.audard@aphp.fr",{"facility":124,"status":75,"city":125,"state":11,"zip":11,"country":126,"countryCode":127,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Robert Bosch Krankenhaus, Department of General Internal Medicine and Nephrology","Stuttgart","Germany","DE",{"type":47,"coordinates":129},[130,131],9.17702,48.78232,{"lat":131,"lon":130},[134,138],{"name":135,"role":32,"phone":136,"phoneExt":11,"email":137},"Jörg Latus, M.D.","+49 711 8101-3496","Joerg.Latus@rbk.de",{"name":139,"role":32,"phone":11,"phoneExt":11,"email":11},"Moritz Schanz, M.D.",{"type":141,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[143,145,147,149,151],{"name":144,"class":6},"Henri Mondor University Hospital",{"name":146,"class":6},"Centre Hospitalier Universitaire de Nice",{"name":148,"class":6},"Medical University of Graz",{"name":150,"class":6},"WiGeV Klinik Ottakring",{"name":152,"class":6},"Robert Bosch Medical Center","100647538","phase-2-a-trial-to-assess-the-efficacy-and-safety-of-obinutuzumab-in-treating-adults-with-minimal-change-disease-mcd-100647538",false,"NCT07710157","A Trial to Assess the Efficacy and Safety of Obinutuzumab in Treating Adults With Minimal Change Disease (MCD)","A Randomized Controlled, Two-arm (1:1 Ratio) Phase IIa Trial to Assess the Efficacy and Safety of Obinutuzumab in Treating Adults With de Novo Minimal Change Disease","OBELIX-NS","Inclusion Criteria:\n\n1. Understands and agrees to comply with the study procedures and provides informed consent as documented by signature\n2. Male or female patients aged 18 years or older at the time of consent\n3. Confirmed first episode of nephrotic syndrome at trial enrolment (serum albumin \\\u003C30g\u002Fl and UPCR \\>3g\u002Fg creatinine (\\>300 mg\u002Fmmol) secondary to de novo MCD\n4. Histologically confirmed MCD (latest before randomization to Arm A or B)\n5. Only applies to women of childbearing potential (WOCBP):\n\n   1. Has a high sensitivity negative urine\u002Fserum pregnancy test at screening\n   2. Agrees to follow contraceptive guidance until 18 months after 2nd obinutuzumab treatment (if randomized to Arm B)\n6. Only applies to trial sites in France: Patients affiliated with the French health care system\n\nExclusion Criteria:\n\n1. MCD due to secondary causes, including malignancy of a type likely to be associated with MCD (i.e., lymphoproliferative disorders), or potentially related to treatment known to be associated with MCD occurrence (lithium, interferon, non-steroidal anti-inflammatory drugs)\n2. Family history of MCD or in a first degree relative unless previously shown to be steroid-responsive\n3. Previous B cell depletion, independent of the agent and treatment target (i.e., CD20, CD38, etc.), within 18 months preceding baseline of the trial, or 12 months if there is evidence of B cell return in peripheral lymphocyte subsets\n4. Previous cyclophosphamide within 6 months preceding baseline of the trial\n5. Treatment with Predniso(lo)ne within screening phase (before randomization)\n6. Evidence of current or past infection with Hepatitis B, C or Human Immunodeficiency Virus (HIV) (unless appropriate prophylaxis is given and no replicating virus is detected)\n7. Evidence of active severe infection requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to first dose of study drug\n8. Severe heart failure or severe, uncontrolled cardiac disease (NYHA class III or IV)\n9. Patient with a history of prior malignancy within 5 years before the first dose of study drug. Exceptions may apply for the following: malignancies with a negligible risk of metastasis or death such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer\n10. Pregnant or breast-feeding women\n11. Live vaccine administration in the four weeks prior to screening and during the study duration of 52 weeks\n12. Previous\u002Fknown hypersensitivity to predniso(lo)ne or obinutuzumab or to any of the excipients to be in accordance with the SmPC of Gazyvaro\n13. Co-enrolment in another clinical trial of an investigational medicinal product\n14. Any other reason which, in the opinion of the Principal Investigator (PI), renders the patient unsuitable for the trial.","ALL","18 Years",{"count":164,"type":165},48,"ESTIMATED","INTERVENTIONAL",[168],"PHASE2","OBELIX-NEPHROSIS (NS)\n\nThe goal of this clinical trial is to learn if obinutuzumab works to treat minimal change disease in adults. It will also learn about the safety of drug obinutuzumab. The main questions it aims to answer are:\n\nIs obinutuzumab non-inferior to glucocorticoids at inducing remission? Does obinutuzumab provide superiority in terms of relapse-free survival after 52 weeks? What medical problems do participants have when receiving obinutuzumab? Researchers will compare drug obinutuzumab to glucocorticoids and aim to phenotype participants with minimal change disease.\n\nParticipants will:\n\nTake the drug obinutuzumab (2 doses) or glucocorticoids Visit the clinic for 8 visits over a period of 52 weeks, plus additional controls when disease relapses occur",[171],"Minimal Change Disease (MCD)","2026-08-13",{"date":174,"type":175},"2026-08-17","ACTUAL",{"date":177,"type":175},"2026-07-13",{"date":179,"type":165},"2029-06-30",{"name":5,"class":6},6]