A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis (NCT04221477)
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham Medical Center — Birmingham, Alabama
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (74 Sites)
Showing the first 25 of 74 sites.
- University of Alabama at Birmingham Medical Center — Birmingham, Alabama
- Wallace Rheumatic Study Center — Beverly Hills, California
- Kaiser Permanente - Fontana — Fontana, California
- Kaiser Permanente - San Francisco Medical Center — San Francisco, California
- Stanford University Medical Center — Stanford, California
- Univ Colorado Health Sci Ctr — Aurora, Colorado
- Yale Medical Group — New Haven, Connecticut
- University of Miami Miller School of Medicine — Miami, Florida
- Georgia Nephrology — Lawrenceville, Georgia
- North Shore University Hospital — Manhasset, New York
- NYU Langone Medical Center — New York, New York
- Columbia University Medical Center — New York, New York
- AD-CARE, University of Rochester Medical Center — Rochester, New York
- The Ohio State University Wexner Medical Center — Columbus, Ohio
- Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma
- University of Texas Southwestern — Dallas, Texas
- Southwest Rheumatology — Mesquite, Texas
- University of Utah Health Science center — Salt Lake City, Utah
- Organizacion Medica de Investigacion — Buenos Aires,
- DOM Centro de Reumatología — Buenos Aires,
- Sanatorio Allende — Córdoba,
- Ser Servicos Especializados Em Reumatologia — Salvador, Estado de Bahia
- Instituto Pro-Renal — Curitiba, Paraná
- Hospital das Clinicas - FMUSP Ribeirao Preto — Ribeirão Preto, São Paulo
- Centro Multidisciplinar de Estudos Clínicos - CEMEC*X* — Santo André, São Paulo
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Lupus Nephritis
- KYSA-1: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis — Palo Alto, California
- Daratumumab to Treat Active Lupus Nephritis — Rochester, Minnesota
- Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis — Glendale, Arizona
- An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases — Phoenix, Arizona
- Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis — Birmingham, Alabama
Explore by condition: All Lupus Nephritis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.