[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100358652":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":49,"centralContacts":57,"locations":58,"responsibleParty":402,"collaborators":404,"id":415,"slug":416,"hasResults":417,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":417,"sex":423,"minAge":424,"maxAge":425,"enrollmentInfo":426,"targetDuration":57,"studyType":429,"phases":430,"briefSummary":432,"conditions":433,"keywords":436,"overallStatus":61,"whyStopped":57,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":451},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: Low Proteinuria Group - Belimumab and Rituximab","EXPERIMENTAL","Open-label pharmacokinetics (PK) phase.\n\nParticipants with low proteinuria classification will receive belimumab weekly subcutaneous injections (52 doses administered Week 0 to Week 51) and rituximab infusions at Weeks 4 and 6.\n\nLow proteinuria classification: The excretion of ≥4 to \\\u003C8 g\u002Fday of protein by the kidneys in adults. (Normal in adults: 0.15 g\u002Fday).",[13,14],"Drug: Belimumab","Drug: Rituximab",{"label":16,"type":10,"description":17,"interventionNames":18},"Part A :High Proteinuria Group - Belimumab and Rituximab","Open-label pharmacokinetics (PK) phase.\n\nParticipants with high proteinuria classification will receive belimumab weekly subcutaneous injections (52 doses administered Week 0 to Week 51) and rituximab infusions at Weeks 4 and 6.\n\nHigh proteinuria classification: The excretion of ≥8 g\u002Fday of protein by the kidneys in adults. (Normal in adults: 0.15 g\u002Fday).",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Part B: Belimumab and Rituximab","Participants in the low proteinuria classification stratification, based upon Part A, and randomized to this arm, will receive subcutaneous belimumab 400 mg (two 200 mg injections) once weekly from weeks 0-3, and then 200 mg once weekly from weeks 4-51. Participants will receive rituximab infusions at Weeks 4 and 6.\n\nAt week 30, participants will be assessed for a response to study treatment. Participants who meet at least two out of the following three criteria at week 30 will be considered to have an inadequate response to study treatment and receive a second course of rituximab (defined as 1000 mg IV given at weeks 34 and 36):\n\n* Anti-PLA2R level is ≥ 25% of baseline\n* Proteinuria is ≥ 50% of baseline\n* Serum albumin is \\\u003C 2.8 g\u002FdL",[13,14],{"label":24,"type":25,"description":26,"interventionNames":27},"Part B: Placebo and Rituximab","PLACEBO_COMPARATOR","Participants in the low proteinuria classification stratification, based upon Part A, and randomized to this arm, will receive subcutaneous belimumab placebo 400 mg (two 200 mg injections) once weekly from weeks 0-3, and then 200 mg once weekly from weeks 4-51. Participants will receive rituximab infusions at Weeks 4 and 6.\n\nAt week 30, participants will be assessed for a response to study treatment. Participants who meet at least two out of the following three criteria at week 30 will be considered to have an inadequate response to study treatment and receive a second course of rituximab (defined as 1000 mg IV given at weeks 34 and 36):\n\n* Anti-PLA2R level is ≥ 25% of baseline\n* Proteinuria is ≥ 50% of baseline\n* Serum albumin is \\\u003C 2.8 g\u002FdL",[28,14],"Drug: Placebo for Belimumab",[30,37,43],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Belimumab","Belimumab is a recombinant, human, IgG1λ monoclonal antibody.\n\nBelimumab will be provided as a 200 mg sterile, liquid product in a prefilled syringe. Each syringe contains 1.0 mL of 200 mg\u002FmL belimumab. Each syringe will be a single use.\n\nStandard Weekly dose:\n\nPart A: 200 mg. administered subcutaneously. Part B: 400 mg (two 200 mg injections) from weeks 0-3, and then 200 mg from weeks 4-51, administered subcutaneously.",[16,9,20],[36],"Benlysta®",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Placebo for Belimumab","The placebo control will be provided as a sterile liquid product in a prefilled syringe. Each syringe will be of a single use.\n\nStandard weekly dose:\n\nPart A: 200 mg. administered subcutaneously. Part B: 400 mg (two 200 mg injections) from weeks 0-3, and then 200 mg from weeks 4-51, administered subcutaneously.",[24],[42],"Belimumab placebo",{"type":31,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Rituximab","Rituximab is a monoclonal antibody with specificity for CD20, a transmembrane protein expressed on B cells from the pre-B to memory cell development stages.\n\nRituximab is supplied at a concentration of 10 mg\u002FmL in either 100 mg\u002F10 mL or 500 mg\u002F50 mL single-use vials for infusion. It is a clear, colorless liquid.\n\nDose: 1000 mg intravenously (IV), Week 4 and -6.",[16,9,20,24],[48],"Rituxan®",[50,54],{"name":51,"affiliation":52,"role":53},"Patrick Nachman","University of Minnesota, Department of Medicine, Division of Renal Diseases and Hypertension","STUDY_CHAIR",{"name":55,"affiliation":56,"role":53},"Iñaki Sanz","Emory University, Department of Medicine, Division of Rheumatology",null,[59,82,99,116,135,151,168,185,201,218,234,251,268,285,302,318,335,352,368,385],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"University of Alabama at Birmingham School of Medicine: Division of Nephrology","RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-86.80249,33.52066,{"lat":71,"lon":70},[74,79],{"name":75,"role":76,"phone":77,"phoneExt":57,"email":78},"Maria El Hachem","CONTACT","205-975-0549","mehachem@uabmc.edu",{"name":80,"role":81,"phone":57,"phoneExt":57,"email":57},"Dana Rizk","PRINCIPAL_INVESTIGATOR",{"facility":83,"status":61,"city":84,"state":85,"zip":86,"country":65,"countryCode":66,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"University of Arkansas","Little Rock","Arkansas","72205",{"type":68,"coordinates":88},[89,90],-92.28959,34.74648,{"lat":90,"lon":89},[93,97],{"name":94,"role":76,"phone":95,"phoneExt":57,"email":96},"Gail Runnells","501-526-7956","RunnellsGailAnn@uams.edu",{"name":98,"role":81,"phone":57,"phoneExt":57,"email":57},"Srilakshmi Ravula",{"facility":100,"status":61,"city":101,"state":102,"zip":103,"country":65,"countryCode":66,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"University of California San Francisco","San Francisco","California","94146",{"type":68,"coordinates":105},[106,107],-122.41942,37.77493,{"lat":107,"lon":106},[110,114],{"name":111,"role":76,"phone":112,"phoneExt":57,"email":113},"Juan Espinoza","415-502-3618","Juan.Espinoza@ucsf.edu",{"name":115,"role":81,"phone":57,"phoneExt":57,"email":57},"Raymond Hsu",{"facility":117,"status":61,"city":118,"state":102,"zip":119,"country":65,"countryCode":66,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Stanford University School of Medicine: Division of Nephrology","Stanford","94305",{"type":68,"coordinates":121},[122,123],-122.16608,37.42411,{"lat":123,"lon":122},[126,130,133],{"name":127,"role":76,"phone":128,"phoneExt":57,"email":129},"Brittany Yeung","650-498-3116","yeungb@stanford.edu",{"name":131,"role":76,"phone":57,"phoneExt":57,"email":132},"Elizabeth Chen","echen15@stanford.edu",{"name":134,"role":81,"phone":57,"phoneExt":57,"email":57},"Fahmeedah Kamal",{"facility":136,"status":61,"city":137,"state":102,"zip":138,"country":65,"countryCode":66,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center:Division of Nephrology and Hypertension","Torrance","90502",{"type":68,"coordinates":140},[141,142],-118.34063,33.83585,{"lat":142,"lon":141},[145,149],{"name":146,"role":76,"phone":147,"phoneExt":57,"email":148},"Janine LaPage","310-222-4104","jlapage@lundquist.org",{"name":150,"role":81,"phone":57,"phoneExt":57,"email":57},"Sharon G. Adler",{"facility":152,"status":61,"city":153,"state":154,"zip":155,"country":65,"countryCode":66,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"University of Colorado","Aurora","Colorado","80045",{"type":68,"coordinates":157},[158,159],-104.83192,39.72943,{"lat":159,"lon":158},[162,166],{"name":163,"role":76,"phone":164,"phoneExt":57,"email":165},"Elizabeth Wagner","303-724-1647","elizabeth.c.wagner@cuanschutz.edu",{"name":167,"role":81,"phone":57,"phoneExt":57,"email":57},"Amber Podoll, MD",{"facility":169,"status":61,"city":170,"state":171,"zip":172,"country":65,"countryCode":66,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Mayo Clinic Jacksonville: Department of Nephrology and Hypertension","Jacksonville","Florida","32224",{"type":68,"coordinates":174},[175,176],-81.65565,30.33218,{"lat":176,"lon":175},[179,183],{"name":180,"role":76,"phone":181,"phoneExt":57,"email":182},"Tia Wilkes","904-953-3636","wilkes.quantia@mayo.edu",{"name":184,"role":81,"phone":57,"phoneExt":57,"email":57},"Nabeel Aslam",{"facility":186,"status":61,"city":187,"state":171,"zip":188,"country":65,"countryCode":66,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"University of Miami Miller School of Medicine, Div of Nephrology","Miami","33136",{"type":68,"coordinates":190},[191,192],-80.19366,25.77427,{"lat":192,"lon":191},[195,199],{"name":196,"role":76,"phone":197,"phoneExt":57,"email":198},"Carlos D Bidot","305-243-8793","cbidot2@med.miami.edu",{"name":200,"role":81,"phone":57,"phoneExt":57,"email":57},"Jair Munoz Mendoza",{"facility":202,"status":61,"city":203,"state":204,"zip":205,"country":65,"countryCode":66,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Johns Hopkins","Baltimore","Maryland","21287",{"type":68,"coordinates":207},[208,209],-76.61219,39.29038,{"lat":209,"lon":208},[212,216],{"name":213,"role":76,"phone":214,"phoneExt":57,"email":215},"Kristin Lyman","734-276-1248","klyman1@jh.edu",{"name":217,"role":81,"phone":57,"phoneExt":57,"email":57},"Duvuru Geetha",{"facility":219,"status":61,"city":220,"state":204,"zip":221,"country":65,"countryCode":66,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"National Institutes of Health Clinical Center","Bethesda","20892",{"type":68,"coordinates":223},[224,225],-77.10026,38.98067,{"lat":225,"lon":224},[228,232],{"name":229,"role":76,"phone":230,"phoneExt":57,"email":231},"Lilian V. Howard, CRNP","301-594-0298","howardlv@mail.nih.gov",{"name":233,"role":81,"phone":57,"phoneExt":57,"email":57},"Meryl A. Waldman",{"facility":235,"status":61,"city":236,"state":237,"zip":238,"country":65,"countryCode":66,"cosmosGeoPoint":239,"geoPoint":243,"contacts":244},"University of Michigan","Ann Arbor","Michigan","48104",{"type":68,"coordinates":240},[241,242],-83.74088,42.27756,{"lat":242,"lon":241},[245,249],{"name":246,"role":76,"phone":247,"phoneExt":57,"email":248},"Jennifer DeLuca","734-936-0369","delucaj@med.umich.edu",{"name":250,"role":81,"phone":57,"phoneExt":57,"email":57},"Andrea Oliverio",{"facility":252,"status":61,"city":253,"state":254,"zip":255,"country":65,"countryCode":66,"cosmosGeoPoint":256,"geoPoint":260,"contacts":261},"University of Minnesota Health Clinical Research Unit","Minneapolis","Minnesota","55455",{"type":68,"coordinates":257},[258,259],-93.26384,44.97997,{"lat":259,"lon":258},[262,266],{"name":263,"role":76,"phone":264,"phoneExt":57,"email":265},"Brady Wallner","612-626-3415","walln080@umn.edu",{"name":267,"role":81,"phone":57,"phoneExt":57,"email":57},"Patrick H. Nachman",{"facility":269,"status":61,"city":270,"state":271,"zip":272,"country":65,"countryCode":66,"cosmosGeoPoint":273,"geoPoint":277,"contacts":278},"Washington University in St. Louis","St Louis","Missouri","63110",{"type":68,"coordinates":274},[275,276],-90.19789,38.62727,{"lat":276,"lon":275},[279,283],{"name":280,"role":76,"phone":281,"phoneExt":57,"email":282},"Emily Green","314-273-0339","green.e@wustl.edu",{"name":284,"role":81,"phone":57,"phoneExt":57,"email":57},"Tinting Li",{"facility":286,"status":61,"city":287,"state":288,"zip":289,"country":65,"countryCode":66,"cosmosGeoPoint":290,"geoPoint":294,"contacts":295},"University of Nebraska","Omaha","Nebraska","68198",{"type":68,"coordinates":291},[292,293],-95.94043,41.25626,{"lat":293,"lon":292},[296,300],{"name":297,"role":76,"phone":298,"phoneExt":57,"email":299},"Tammy Jones, RN","402-559-4335","tamjones@unmc.edu",{"name":301,"role":81,"phone":57,"phoneExt":57,"email":57},"Prasanth Ravipati",{"facility":303,"status":61,"city":304,"state":304,"zip":305,"country":65,"countryCode":66,"cosmosGeoPoint":306,"geoPoint":310,"contacts":311},"Columbia University Medical Center: Division of Nephrology","New York","10032",{"type":68,"coordinates":307},[308,309],-74.00597,40.71427,{"lat":309,"lon":308},[312,316],{"name":313,"role":76,"phone":314,"phoneExt":57,"email":315},"Anup Pradhan","212-305-5037","arp2209@cumc.columbia.edu",{"name":317,"role":81,"phone":57,"phoneExt":57,"email":57},"Andrew S. Bomback",{"facility":319,"status":61,"city":320,"state":321,"zip":322,"country":65,"countryCode":66,"cosmosGeoPoint":323,"geoPoint":327,"contacts":328},"University of North Carolina School of Medicine: Division of Nephrology and Hypertension, Kidney Center","Chapel Hill","North Carolina","27599-",{"type":68,"coordinates":324},[325,326],-79.05584,35.9132,{"lat":326,"lon":325},[329,333],{"name":330,"role":76,"phone":331,"phoneExt":57,"email":332},"Anne Froment","919-445-2622","anne_froment@med.unc.edu",{"name":334,"role":81,"phone":57,"phoneExt":57,"email":57},"Vimal K. Derebail",{"facility":336,"status":61,"city":337,"state":338,"zip":339,"country":65,"countryCode":66,"cosmosGeoPoint":340,"geoPoint":344,"contacts":345},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":68,"coordinates":341},[342,343],-81.69541,41.4995,{"lat":343,"lon":342},[346,350],{"name":347,"role":76,"phone":348,"phoneExt":57,"email":349},"Sandra Hodnick","216-444-0124","hodnics@ccf.org",{"name":351,"role":81,"phone":57,"phoneExt":57,"email":57},"John Sedor",{"facility":353,"status":61,"city":354,"state":338,"zip":355,"country":65,"countryCode":66,"cosmosGeoPoint":356,"geoPoint":360,"contacts":361},"Ohio State University Wexner Medical Center: Division of Nephrology","Columbus","43210",{"type":68,"coordinates":357},[358,359],-82.99879,39.96118,{"lat":359,"lon":358},[362,366],{"name":363,"role":76,"phone":364,"phoneExt":57,"email":365},"Laci Roberts","614-685-5323","laci.roberts@osumc.edu",{"name":367,"role":81,"phone":57,"phoneExt":57,"email":57},"Isabelle Ayoub",{"facility":369,"status":61,"city":370,"state":371,"zip":372,"country":65,"countryCode":66,"cosmosGeoPoint":373,"geoPoint":377,"contacts":378},"University of Pennsylvania: Department of Medicine: Renal-Electrolyte and Hypertension Division","Philadelphia","Pennsylvania","19104",{"type":68,"coordinates":374},[375,376],-75.16362,39.95238,{"lat":376,"lon":375},[379,383],{"name":380,"role":76,"phone":381,"phoneExt":57,"email":382},"Krishna Kallem, MD, MPH","484-358-0315","Krishna.Kallem@pennmedicine.upenn.edu",{"name":384,"role":81,"phone":57,"phoneExt":57,"email":57},"Gaia Coppock",{"facility":386,"status":61,"city":387,"state":388,"zip":389,"country":65,"countryCode":66,"cosmosGeoPoint":390,"geoPoint":394,"contacts":395},"Providence Medical Research Center, Providence Health Care: Nephrology","Spokane","Washington","99204",{"type":68,"coordinates":391},[392,393],-117.42908,47.65966,{"lat":393,"lon":392},[396,400],{"name":397,"role":76,"phone":398,"phoneExt":57,"email":399},"Nicole Maser, MSH, RN","509-474-5315","nicole.maser@providence.org",{"name":401,"role":81,"phone":57,"phoneExt":57,"email":57},"Katherine R. Tuttle",{"type":403,"investigatorFullName":57,"investigatorTitle":57,"investigatorAffiliation":57,"oldNameTitle":57,"oldOrganization":57},"SPONSOR",[405,408,411,413],{"name":406,"class":407},"Immune Tolerance Network (ITN)","NETWORK",{"name":409,"class":410},"GlaxoSmithKline","INDUSTRY",{"name":412,"class":410},"PPD Development, LP",{"name":414,"class":410},"Rho Federal Systems Division, Inc.","100358652","phase-2-belimumab-with-rituximab-for-primary-membranous-nephropathy-100358652",false,"NCT03949855","Belimumab With Rituximab for Primary Membranous Nephropathy","Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (ITN080AI)","REBOOT","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be eligible for this study-\n\n1. Age 18 to 75 years inclusive\n2. Diagnosis of one of the following:\n\n   1. Primary MN confirmed by a kidney biopsy within the past 5 years\n   2. Primary MN that is relapsing following a CR (Section 3.3.1) or PR (Section 3.3.2), confirmed by a kidney biopsy within the past 7 years\n   3. Nephrotic syndrome with eGFR \\> 60 mL\u002Fmin\u002F1.73m2 and no history of immunosuppressant treatment (e.g. glucocorticoids, cyclophosphamide, cyclosporine A, tacrolimus, B-cell depleting agent) for nephrotic syndrome, and without evidence of a secondary cause of nephrotic syndrome\n   4. Nephrotic syndrome and a contraindication to kidney biopsy (e.g., anticoagulation, solitary kidney, body habitus that increases the risk of biopsy, or other contraindication in the opinion of the investigator), and without evidence of a secondary cause of nephrotic syndrome\n3. Serum anti-PLA2R positive\n4. eGFR ≥ 30 mL\u002Fmin\u002F1.73m2 while on maximally tolerated RAS blockade\n5. Proteinuria:\n\n   1. ≥ 4 and \\\u003C 8 g\u002Fday that has persisted for at least the previous 3 months while on maximally tolerated RAS blockade. Documentation of persistent proteinuria may be from a 24-hour collection or calculated from a spot urine collection. Or,\n   2. ≥ 8 g\u002Fday while on maximally tolerated RAS blockade\n6. Blood pressure while on maximally tolerated RAS blockade:\n\n   1. Systolic blood pressure ≤ 140 mmHg\n   2. Diastolic blood pressure ≤ 90 mmHg\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria will not be eligible for this study-\n\n1. Secondary cause of MN (e.g., SLE, drug, infection, malignancy) suggested by review of the patient's medical history and\u002For clinical presentation\n2. Rituximab use within the previous 12 months\n3. Rituximab use \\> 12 months ago:\n\n   1. With an undetectable CD19 B cell count, or\n   2. Did not result in a CR (Section 3.3.1) or PR (Section 3.3.2) with rituximab treatment alone (e.g., without other immunosuppressive or immunomodulatory therapy)\n4. Use of anti-B cell therapy other than rituximab within the previous 12 months (or 5 half-lives, whichever is greater)\n5. Cyclophosphamide use within the past 3 months\n6. Use of other immunosuppressive medications such as cyclosporine or tacrolimus within the past 30 days\n7. Use of systemic corticosteroids within the past 30 days\n8. Use of any biologic investigational agent (defined as any drug not approved for sale in the country it is used) in the previous 12 months\n9. Use of any non-biologic investigational agent in the past 30 days (or 5 half-lives, whichever is greater)\n10. Poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) ≥ 9.0%\n11. Patients with diabetic glomerulopathy on renal biopsy that is:\n\n    1. Greater than Class I diabetic glomerulopathy, or\n    2. Class I diabetic glomerulopathy with a history of poor diabetic control (e.g., HbA1c ≥ 9.0%) since time of biopsy\n12. Unstable kidney function defined as \\> 20% decrease in eGFR during the previous 3 months due to primary MN, as determined by the site investigator in consultation with the protocol chair\n13. Decrease in proteinuria by 50% or more during the previous 12 months\n14. WBC count \\\u003C 3.0 x 103\u002Fμl\n15. Absolute neutrophil count \\\u003C 1.5 x 103\u002Fμl\n16. Moderately severe anemia (hemoglobin \\\u003C 9 g\u002FdL)\n17. History of primary immunodeficiency\n18. Serum IgA \\\u003C 10 mg\u002FdL\n19. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2x the upper limit of normal (ULN)\n20. Positive HIV serology\n21. Positive HCV serology, unless treated with anti-viral therapy with achievement of a sustained virologic response (undetectable viral load 24 weeks after cessation of therapy)\n22. Evidence of current or prior infection with hepatitis B, as indicated by positive HBsAg or positive HBcAb\n23. Positive QuantiFERON - TB Gold test results. PPD tuberculin test may be substituted for QuantiFERON - TB Gold test\n24. History of lung disease with FVC \\\u003C 70% predicted, DLCO \\\u003C 70% predicted, or requiring supplemental oxygen\n25. History of malignant neoplasm within the last 5 years except for basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the uterine cervix treated locally and with no evidence of metastatic disease for 3 years\n26. Absence of individualized, age-appropriate cancer screening\n27. Women of child-bearing potential who are pregnant, nursing, or unwilling to be sexually inactive or use FDA-approved contraception until week 104\n28. Acute or chronic infection, including current use of suppressive therapy for chronic infection, hospitalization for treatment of infection in the past 60 days, or parenteral anti-microbial (including anti-bacterial, anti-viral, or anti-fungal agents) use in the past 60 days for infection\n29. History of an anaphylactic reaction or known sensitivity or intolerance to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies, including rituximab or belimumab\n30. Evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and\u002For any suicidal ideation in the last 2 months, or who in the investigator's judgment, poses a significant suicide risk\n31. Evidence of current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence in the past 12 months\n32. Vaccination with a live vaccine within the past 30 days\n33. Other diseases or conditions or other clinically significant abnormal laboratory value which in the opinion of the investigator would put the patient at risk or confound the results of the study\n34. Inability to comply with study and follow-up procedures","ALL","18 Years","75 Years",{"count":427,"type":428},58,"ESTIMATED","INTERVENTIONAL",[431],"PHASE2","The primary objective of this study is to evaluate the effectiveness of belimumab and intravenous rituximab co-administration at inducing a complete or partial remission (CR or PR) compared to rituximab alone in participants with primary membranous nephropathy.\n\nBackground:\n\nPrimary membranous nephropathy (MN) is among the most common causes of nephrotic syndrome in adults. MN affects individuals of all ages and races. The peak incidence of MN is in the fifth decade of life.\n\nPrimary MN is recognized to be an autoimmune disease, a disease where the body's own immune system causes damage to kidneys. This damage can cause the loss of too much protein in the urine.\n\nDrugs used to treat MN aim to reduce the attack by one's own immune system on the kidneys by blocking inflammation and reducing the immune system's function. These drugs can have serious side effects and often do not cure the disease. There is a need for new treatments for MN that are better at improving the disease while reducing fewer treatment associated side effects.\n\nIn this study, researchers will evaluate if treatment with a combination of two different drugs, belimumab and rituximab, is effective at blocking the immune attacks on the kidney compared to rituximab alone. Rituximab works by decreasing a type of immune cell, called B cells. B cells are known to have a role in MN. Once these cells are removed, disease may become less active or even inactive. However, after stopping treatment, the body will make new B cells which may cause disease to become active again.\n\nBelimumab works by decreasing the new B cells produced by the body and, may even change the type of new B cells subsequently produced. Belimumab is approved by the US Food and Drug Administration (FDA) to treat systemic lupus erythematosus (also referred to as lupus or SLE). Rituximab is approved by the FDA to treat some types of cancer, rheumatoid arthritis, and vasculitis. Neither rituximab nor belimumab is approved by the FDA to treat MN. Treatment with a combination of belimumab and rituximab has not been studied in individuals with MN, but has been tested in other autoimmune diseases, including lupus nephritis and Sjögren's syndrome.",[434,435],"Membranous Nephropathy","Nephrotic Syndrome",[437,438,439,440,441],"Primary Membranous Nephropathy","nephrotic syndrome","Pharmacokinetics (PK) Analysis","Double-Blind (Masked), Placebo-Controlled Clinical Trial","Co-administered belimumab and rituximab","2026-06-22",{"date":444,"type":445},"2026-06-24","ACTUAL",{"date":447,"type":445},"2020-03-06",{"date":449,"type":428},"2030-03-01",{"name":5,"class":6},20]