[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05039619":3,"trial-entities:NCT05039619":501,"trial-summary:NCT05039619":505},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":62,"secondary_outcomes":70,"sex":132,"minimum_age":133,"maximum_age":134,"healthy_volunteers":135,"eligibility_criteria":136,"std_ages":159,"locations":161,"central_contacts":480,"overall_officials":488,"references":492,"see_also_links":497},"NCT05039619","WA42985","A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants","A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients With Active Class III or IV Lupus Nephritis, Including an Evaluation of Open Label Safety and PK in a Cohort of Pediatric Patients (Aged 5 to \u003C 12)","RECRUITING","2030-06-14","2026-08","2026-08-05","2022-05-12","Hoffmann-La Roche","INDUSTRY",true,"This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to \\\u003C12 with LN.",null,[19],"Lupus Nephritis",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},40,"ESTIMATED",[29,38,42,46,50,54,58],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":36},"DRUG","Obinutuzumab","Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1, Day 14, Week 24, Week 26 and Week 52.",[34,35],"Blinded Obinutuzumab","Open-Label Obinutuzumab",[37],"Gazyva",{"type":30,"name":39,"description":40,"armGroupLabels":41},"Placebo","Placebo matching obinutuzumab will be administered by IV on Day 1, Day 14, Week 24, Week 26 and Week 52.",[39],{"type":30,"name":43,"description":44,"armGroupLabels":45},"Mycophenolate Mofetil","Mycophenolate Mofetil (MMF) will be taken by home administration orally at a target dose of 1200 mg\u002Fm\\^2\u002Fday to a maximum of 2.5g\u002Fday from baseline (Day 1) onwards.",[34,35,39],{"type":30,"name":47,"description":48,"armGroupLabels":49},"Acetaminophen\u002Fparacetamol","Acetaminophen 1000 mg will be administered as pre-medication prior to infusions.",[34,35,39],{"type":30,"name":51,"description":52,"armGroupLabels":53},"Diphenhydramine hydrochloride (HCl)","Diphenhydramine HCl 50 mg will be administered as pre-medication prior to infusions.",[34,35,39],{"type":30,"name":55,"description":56,"armGroupLabels":57},"Methylprednisolone","Methylprednisolone 80 mg IV will be administered as pre-medication prior to infusions.",[34,35,39],{"type":30,"name":59,"description":60,"armGroupLabels":61},"Prednisone","Oral prednisone or equivalent corticosteroid will be taken by home administration daily to a maximum dose of 60mg\u002Fday followed by a guided taper to 5mg\u002Fday or less by Week 24.",[34,35,39],[63,67],{"measure":64,"description":65,"timeFrame":66},"Percentage of Participants who Achieve a Complete Renal Response (CRR) (AP)","CRR is defined as achievement of all of the following:\n\n* Urinary protein-to-creatinine ratio (UPCR) \\\u003C0.5 g\u002Fg\n* Estimated Glomerular Filtration Rate (eGFR) \\>=85% of baseline\n* No occurrence of intercurrent events","Week 76",{"measure":68,"timeFrame":69},"Percentage of Participants with Adverse Events (PP)","Baseline to Week 76",[71,74,76,78,82,84,86,89,92,94,96,98,100,102,105,107,109,111,114,117,119,122,124,126,128,130],{"measure":72,"timeFrame":73},"Percentage of Participants Achieving a CRR (AP)","Weeks 24 and 52",{"measure":75,"timeFrame":66},"Percentage of Participants who Achieve CRR with Successful Prednisone Taper (AP)",{"measure":77,"timeFrame":66},"Percentage of Participants who Achieve a PRR (AP)",{"measure":79,"description":80,"timeFrame":81},"Percentage of Participants Achieving an Overall Response (CRR or PRR) (AP)","PRR is defined as:\n\nachievement of all of the following:\n\n* \\>=50% reduction in urinary protein-to-creatinine ratio (UPCR) from baseline\n* UPCR \\\u003C 1 g\u002Fg (or \\\u003C 3 g\u002Fg if the baseline UPCR was \\>=3 g\u002Fg)\n* eGFR \\>=85% of baseline\n* No occurrence of intercurrent events","Weeks 24, 52, and 76",{"measure":83,"timeFrame":69},"Change in UPCR (AP)",{"measure":85,"timeFrame":69},"Change in eGFR (AP)",{"measure":87,"timeFrame":88},"Time to Onset of CRR over the Course of 76 weeks (AP)","Up to Week 76",{"measure":90,"timeFrame":91},"Percentage of Participants who Experience Treatment Failure (AP)","Week 12 to Week 76",{"measure":93,"timeFrame":69},"Change in anti-dsDNA titers (AP)",{"measure":95,"timeFrame":69},"Change in C3 Complement Levels (AP)",{"measure":97,"timeFrame":69},"Change in C4 Complement Levels (AP)",{"measure":99,"timeFrame":69},"Percentage of Participants with Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 (AP)",{"measure":101,"timeFrame":69},"Serum Concentrations of Obinutuzumab (AP)",{"measure":103,"timeFrame":104},"Percentage of Participants Achieving B-cell Depletion (AP)","Baseline, Weeks 4, 24, 52 and 76",{"measure":106,"timeFrame":69},"Change in Pediatric Quality of Life Inventory-Multidimensional Fatigue Scale (PedsQL)-Fatigue Total Score (AP)",{"measure":108,"timeFrame":69},"Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) (AP)",{"measure":110,"timeFrame":69},"Change from Baseline in Child Health Questionnaire-Parent Form 28 (CHQ-PF28) Domain Scores (AP)",{"measure":112,"timeFrame":113},"Percentage of Participants with Anti-drug Antibodies (ADA) (AP)","Weeks 0, 24, 52 and 76",{"measure":115,"timeFrame":116},"Relationship Between ADA Status and Percentage of Participants Achieving a CRR (AP)","Weeks 24, 52 and 76",{"measure":118,"timeFrame":66},"Percentage of Participants Achieving a CRR (PP)",{"measure":120,"description":121,"timeFrame":66},"Percentage of Participants Achieving an Overall Response (PP)","PRR is defined as achievement of all of the following:\n\n* \\>=50% reduction in UPCR from baseline\n* UPCR \\\u003C 1 g\u002Fg (or \\\u003C 3 g\u002Fg if the baseline UPCR was \\>=3 g\u002Fg)\n* eGFR \\>=85% of baseline\n* No occurrence of intercurrent events",{"measure":123,"timeFrame":66},"Percentage of Participants who Achieve CRR with Successful Prednisone Taper (PP)",{"measure":125,"timeFrame":69},"Change in eGFR (PP)",{"measure":127,"timeFrame":104},"Percentage of Participants Achieving B-cell Depletion (PP)",{"measure":129,"timeFrame":113},"Percentage of Participants with ADAs (PP)",{"measure":131,"timeFrame":69},"Change in anti-dsDNA titers (PP)","ALL","5 Years","17 Years",false,{"inclusion":137,"exclusion":145,"raw_text":158},[138,139,140,141,142,143,144],"Participants who are age 12 to \\\u003C18 years at the time of randomization","Participants who are age 5 to \\\u003C12 years (younger participant cohort) at the time of randomization once recruitment is open. (Investigators will be notified by the Sponsor when recruitment is open to this younger population)","International Society of Nephrology and the Renal Pathology Society (ISN\u002FRPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed in the 12 months prior to or during screening","Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible","Diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria","Significant proteinuria defined by a UPCR above \\> 0.5 based on a first-morning void (FMV) collection at screening","During the 12 months prior to or during screening, all participants must have received at least one dose of pulse-range IV methylprednisolone (typically 30 mg\u002Fkg, maximum of 1000 mg per dose) or equivalent for the treatment of the current episode of active LN.",[146,147,148,149,150,151,152,153,154,155,156,157],"Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia","Sclerosis in \\>50% of glomeruli on renal biopsy","Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions","Presence of rapidly progressive glomerulonephritis","Pure Class V LN","Intolerance or contraindication to study therapies","Active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV anti-infective medications within 4 weeks prior to screening, or completion of oral anti-infectives within 2 weeks prior to randomization","History of or currently active primary or secondary immunodeficiency, including known history of HIV infection and other severe Immunodeficiency blood disorders","History of serious recurrent or chronic infection","History of or current cancer, including solid tumors, hematological malignancies, and carcinoma in situ (except basal cell carcinoma and squamous cell carcinoma of the skin that have been excised and cured) within the past 5 years","Significant or uncontrolled concomitant medical disease which, in the investigator's opinion, would preclude participant participation","Currently active alcohol or drug abuse or history of alcohol or drug abuse","Inclusion Criteria:\n\n* Participants who are age 12 to \\\u003C18 years at the time of randomization\n* Participants who are age 5 to \\\u003C12 years (younger participant cohort) at the time of randomization once recruitment is open. (Investigators will be notified by the Sponsor when recruitment is open to this younger population)\n* International Society of Nephrology and the Renal Pathology Society (ISN\u002FRPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed in the 12 months prior to or during screening\n* Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible\n* Diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria\n* Significant proteinuria defined by a UPCR above \\> 0.5 based on a first-morning void (FMV) collection at screening\n* During the 12 months prior to or during screening, all participants must have received at least one dose of pulse-range IV methylprednisolone (typically 30 mg\u002Fkg, maximum of 1000 mg per dose) or equivalent for the treatment of the current episode of active LN.\n\nExclusion Criteria:\n\n* Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia\n* Sclerosis in \\>50% of glomeruli on renal biopsy\n* Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions\n* Presence of rapidly progressive glomerulonephritis\n* Pure Class V LN\n* Intolerance or contraindication to study therapies\n* Active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV anti-infective medications within 4 weeks prior to screening, or completion of oral anti-infectives within 2 weeks prior to randomization\n* History of or currently active primary or secondary immunodeficiency, including known history of HIV infection and other severe Immunodeficiency blood disorders\n* History of serious recurrent or chronic infection\n* History of or current cancer, including solid tumors, hematological malignancies, and carcinoma in situ (except basal cell carcinoma and squamous cell carcinoma of the skin that have been excised and cured) within the past 5 years\n* Significant or uncontrolled concomitant medical disease which, in the investigator's opinion, would preclude participant participation\n* Currently active alcohol or drug abuse or history of alcohol or drug abuse",[160],"CHILD",[162,171,178,186,194,202,210,218,226,234,243,251,260,268,276,282,287,296,304,312,319,323,330,339,347,355,364,372,380,387,394,402,409,415,423,427,434,440,447,451,458,466,473],{"facility":163,"status":8,"city":164,"state":165,"zip":166,"country":167,"geoPoint":168},"Loma Linda University health","Loma Linda","California","92354","United States",{"lat":169,"lon":170},34.04835,-117.26115,{"facility":172,"status":8,"city":173,"state":165,"zip":174,"country":167,"geoPoint":175},"UCSF Benioff Childrens Hospital","San Francisco","94158",{"lat":176,"lon":177},37.77493,-122.41942,{"facility":179,"status":8,"city":180,"state":181,"zip":182,"country":167,"geoPoint":183},"Children's Hospital Colorado, Anchutz Medical Campus","Aurora","Colorado","80045",{"lat":184,"lon":185},39.72943,-104.83192,{"facility":187,"status":8,"city":188,"state":189,"zip":190,"country":167,"geoPoint":191},"Emory Children's Center","Atlanta","Georgia","30322",{"lat":192,"lon":193},33.749,-84.38798,{"facility":195,"status":8,"city":196,"state":197,"zip":198,"country":167,"geoPoint":199},"Indiana University Health University Hospital","Indianapolis","Indiana","46202",{"lat":200,"lon":201},39.76838,-86.15804,{"facility":203,"status":8,"city":204,"state":205,"zip":206,"country":167,"geoPoint":207},"Louisiana State University","Shreveport","Louisiana","71103",{"lat":208,"lon":209},32.52515,-93.75018,{"facility":211,"status":8,"city":212,"state":213,"zip":214,"country":167,"geoPoint":215},"Hackensack University Medical Center","Hackensack","New Jersey","07601",{"lat":216,"lon":217},40.88593,-74.04347,{"facility":219,"status":8,"city":220,"state":221,"zip":222,"country":167,"geoPoint":223},"Cohen Children's Medical Center of New York","Queens","New York","11042",{"lat":224,"lon":225},40.68149,-73.83652,{"facility":227,"status":8,"city":228,"state":229,"zip":230,"country":167,"geoPoint":231},"Cincinnati Childrens Hospital","Cincinnati","Ohio","45229",{"lat":232,"lon":233},39.12711,-84.51439,{"facility":235,"status":236,"city":237,"state":238,"zip":239,"country":167,"geoPoint":240},"Chldren?s Hospital of Philadelphia","WITHDRAWN","Philadelphia","Pennsylvania","19104",{"lat":241,"lon":242},39.95238,-75.16362,{"facility":244,"status":236,"city":245,"state":246,"zip":247,"country":167,"geoPoint":248},"Texas Arthritis Center","El Paso","Texas","79902",{"lat":249,"lon":250},31.75872,-106.48693,{"facility":252,"status":8,"city":253,"state":254,"zip":255,"country":256,"geoPoint":257},"Ser Servicos Especializados Em Reumatologia","Salvador","Estado de Bahia","40150-150","Brazil",{"lat":258,"lon":259},-12.97563,-38.49096,{"facility":261,"status":8,"city":262,"state":263,"zip":264,"country":256,"geoPoint":265},"Hospital Universitário Onofre Lopes - UFRN","Petrópolis","Rio Grande do Norte","59012-300",{"lat":266,"lon":267},-5.86889,-36.70833,{"facility":269,"status":8,"city":270,"state":271,"zip":272,"country":256,"geoPoint":273},"Centro de Pesquisa São Lucas","Campinas","São Paulo","13060-904",{"lat":274,"lon":275},-22.90556,-47.06083,{"facility":277,"status":8,"city":271,"state":271,"zip":278,"country":256,"geoPoint":279},"Hospital das Clinicas - FMUSP","05403-000",{"lat":280,"lon":281},-23.5475,-46.63611,{"facility":283,"status":284,"city":271,"zip":285,"country":256,"geoPoint":286},"Universidade Federal de Sao Paulo - UNIFES","ACTIVE_NOT_RECRUITING","04024-002",{"lat":280,"lon":281},{"facility":288,"status":8,"city":289,"state":290,"zip":291,"country":292,"geoPoint":293},"The Hospital for Sick Children","Toronto","Ontario","M5G 1X8","Canada",{"lat":294,"lon":295},43.70643,-79.39864,{"facility":297,"status":8,"city":298,"state":299,"zip":300,"country":292,"geoPoint":301},"Hospital Sainte-Justine","Montreal","Quebec","H3T 1C5",{"lat":302,"lon":303},45.50884,-73.58781,{"facility":305,"status":8,"city":306,"zip":307,"country":308,"geoPoint":309},"CH de Bicêtre","Le Kremlin-Bicêtre","94275","France",{"lat":310,"lon":311},48.81471,2.36073,{"facility":313,"status":8,"city":314,"zip":315,"country":308,"geoPoint":316},"Hôpital Robert Debré","Paris","75019",{"lat":317,"lon":318},48.85341,2.3488,{"facility":320,"status":8,"city":314,"zip":321,"country":308,"geoPoint":322},"Hop Necker Enfants Malades","75743",{"lat":317,"lon":318},{"facility":324,"status":8,"city":325,"zip":326,"country":308,"geoPoint":327},"CHU de Toulouse - Hôpital des Enfants","Toulouse","31000",{"lat":328,"lon":329},43.60426,1.44367,{"facility":331,"status":8,"city":332,"state":333,"zip":334,"country":335,"geoPoint":336},"Ospedale Pediatrico Bambino Gesu","Rome","Lazio","00165","Italy",{"lat":337,"lon":338},41.89193,12.51133,{"facility":340,"status":8,"city":341,"state":342,"zip":343,"country":335,"geoPoint":344},"IRCCS G. Gaslini","Genoa","Liguria","16148",{"lat":345,"lon":346},44.40478,8.94439,{"facility":348,"status":8,"city":349,"state":350,"zip":351,"country":335,"geoPoint":352},"Clinica Pediatrica II De Marchi","Milan","Lombardy","20122",{"lat":353,"lon":354},45.46427,9.18951,{"facility":356,"status":8,"city":357,"state":358,"zip":359,"country":360,"geoPoint":361},"CREA Hospital Mexico Americano","Guadalajara","Jalisco","44620","Mexico",{"lat":362,"lon":363},20.67738,-103.34749,{"facility":365,"status":8,"city":366,"state":367,"zip":368,"country":360,"geoPoint":369},"Clinstile S.A de C.V.","Mexico City","Mexico CITY (federal District)","06700",{"lat":370,"lon":371},19.42847,-99.12766,{"facility":373,"status":8,"city":374,"state":375,"zip":376,"country":360,"geoPoint":377},"Hospital Universitario Dr. Jose Eleuterio Gonzalez","Monterrey","Nuevo León","64460",{"lat":378,"lon":379},25.68435,-100.31721,{"facility":381,"status":284,"city":382,"country":383,"geoPoint":384},"Instituto de Ginecología y Reproducción","Lima","Peru",{"lat":385,"lon":386},-12.04318,-77.02824,{"facility":388,"status":284,"city":389,"zip":390,"country":383,"geoPoint":391},"Clinica El Golf","San Isidro","L27 Lima",{"lat":392,"lon":393},-12.09655,-77.04258,{"facility":395,"status":8,"city":396,"zip":397,"country":398,"geoPoint":399},"Uniwersyteckie Centrum Kliniczne","Gdansk","80-294","Poland",{"lat":400,"lon":401},54.35227,18.64912,{"facility":403,"status":236,"city":404,"zip":405,"country":398,"geoPoint":406},"Szpital Specjalistyczny dla Dzieci i Doroslych","Torun","87-100",{"lat":407,"lon":408},53.01375,18.59814,{"facility":410,"status":236,"city":411,"state":412,"zip":413,"country":414},"Saint-Petersburg State","St-peterburg","Sankt-Peterburg","194100","Russia",{"facility":416,"status":236,"city":417,"zip":418,"country":419,"geoPoint":420},"Red Cross War Memorial Children?s Hospital","Cape Town","7700","South Africa",{"lat":421,"lon":422},-33.92584,18.42322,{"facility":424,"status":236,"city":417,"zip":425,"country":419,"geoPoint":426},"Groote Schuur Hospital","7925",{"lat":421,"lon":422},{"facility":428,"status":8,"city":429,"zip":430,"country":419,"geoPoint":431},"Panaroma Medical Center","Panorama","7500",{"lat":432,"lon":433},-28.75383,31.89113,{"facility":435,"status":8,"city":436,"state":437,"zip":438,"country":439},"Hospital Sant Joan De Deu","Esplugas de Llobregat","Barcelona","08950","Spain",{"facility":441,"status":8,"city":442,"zip":443,"country":439,"geoPoint":444},"Hospital Ramon y Cajal","Madrid","28034",{"lat":445,"lon":446},40.4165,-3.70256,{"facility":448,"status":8,"city":442,"zip":449,"country":439,"geoPoint":450},"Hospital de La Paz","28046",{"lat":445,"lon":446},{"facility":452,"status":8,"city":453,"zip":454,"country":439,"geoPoint":455},"Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica","Valencia","46026",{"lat":456,"lon":457},39.47391,-0.37966,{"facility":459,"status":236,"city":460,"zip":461,"country":462,"geoPoint":463},"Royal Hospital For Children","Glasgow","G51 4TF","United Kingdom",{"lat":464,"lon":465},55.86515,-4.25763,{"facility":467,"status":8,"city":468,"zip":469,"country":462,"geoPoint":470},"Alder Hey Childrens Hospital","Liverpool","L12 2AP",{"lat":471,"lon":472},53.41058,-2.97794,{"facility":474,"status":8,"city":475,"zip":476,"country":462,"geoPoint":477},"Great Ormond Street Hospital for Children","London","WC1N 3JH",{"lat":478,"lon":479},51.50853,-0.12574,[481,486],{"name":482,"role":483,"phone":484,"email":485},"Reference Study ID Number: WA42985 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728 (U.S. and Canada)","global.rochegenentechtrials@roche.com",{"name":487,"role":483},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[489],{"name":490,"affiliation":13,"role":491},"Clinical Trials","STUDY_DIRECTOR",[493],{"pmid":494,"type":495,"citation":496},"37678236","DERIVED","Dossier C, Bonneric S, Baudouin V, Kwon T, Prim B, Cambier A, Couderc A, Moreau C, Deschenes G, Hogan J. Obinutuzumab in Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome in Children. Clin J Am Soc Nephrol. 2023 Dec 1;18(12):1555-1562. doi: 10.2215\u002FCJN.0000000000000288. Epub 2023 Sep 6.",[498],{"label":499,"url":500},"Please use this form to submit your questions for a faster response: https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.","https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",{"nct_id":4,"conditions":502,"biomarkers":504},[503],"Lupus Glomerulonephritis",[],{"nct_id":4,"found":15,"summary":506,"prompt_version":516},{"design":507,"status":508,"heading":509,"summary":510,"follow_up":511,"word_count":512,"commitments":513,"compensation":514,"drugs_mentioned":515},"This is a Phase II, randomized, double-blind, placebo-controlled study involving up to 40 participants. It will compare obinutuzumab to a placebo in adolescents, and also look at obinutuzumab in an open-label way for younger children.","completed","Obinutuzumab for Lupus Nephritis in Adolescents and Children","This study is testing a drug called obinutuzumab in young people with lupus nephritis (lupus affecting the kidneys). It aims to see how safe and effective obinutuzumab is, and how the body handles the drug. Participants will receive obinutuzumab or a placebo (an inactive substance) through an IV, along with mycophenolate mofetil (an oral medication). Pre-medications like acetaminophen and diphenhydramine will be given before infusions. The study is looking for how many participants achieve a complete kidney response and any side effects. It includes adolescents aged 12 to under 18, and will later include children aged 5 to under 12. The study is currently recruiting adolescents, with recruitment for younger children to follow.","Participants will be followed for safety and kidney response from baseline up to Week 76 (about 1.5 years).",113,"Participants will receive IV infusions of obinutuzumab or placebo on specific days over about a year. They will also take mycophenolate mofetil orally at home daily.","Not stated in the trial record.",[31,39,43],"v2"]