A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Lupus Nephritis
In brief
This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in participants with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.
Key facts
- Study ID
- NCT04221477
- Run by
- Hoffmann-La Roche
- People needed
- 271
- Starts
- 2020-08-10
- Expected to finish
- 2031-03-02
- Last updated by the study team
- 2026-07-21
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Wallace Rheumatic Study Center — Beverly Hills, California, United States
- Kaiser Permanente - Fontana — Fontana, California, United States
- Kaiser Permanente - San Francisco Medical Center — San Francisco, California, United States
- Stanford University Medical Center — Stanford, California, United States
- Univ Colorado Health Sci Ctr — Aurora, Colorado, United States
- Yale Medical Group — New Haven, Connecticut, United States
- University of Miami Miller School of Medicine — Miami, Florida, United States
- Georgia Nephrology — Lawrenceville, Georgia, United States
- North Shore University Hospital — Manhasset, New York, United States
- NYU Langone Medical Center — New York, New York, United States
- Columbia University Medical Center — New York, New York, United States
- AD-CARE, University of Rochester Medical Center — Rochester, New York, United States
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
- Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States
- University of Texas Southwestern — Dallas, Texas, United States
- Southwest Rheumatology — Mesquite, Texas, United States
- University of Utah Health Science center — Salt Lake City, Utah, United States
- Organizacion Medica de Investigacion — Buenos Aires, Argentina
- DOM Centro de Reumatología — Buenos Aires, Argentina
- Sanatorio Allende — Córdoba, Argentina
- Ser Servicos Especializados Em Reumatologia — Salvador, Estado de Bahia, Brazil
- Instituto Pro-Renal — Curitiba, Paraná, Brazil
- Hospital das Clinicas - FMUSP Ribeirao Preto — Ribeirão Preto, São Paulo, Brazil
- Centro Multidisciplinar de Estudos Clínicos - CEMEC*X* — Santo André, São Paulo, Brazil
- University of Alabama at Birmingham Medical Center — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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