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Clinical Trial Active — Not Recruiting Phase III NCT04221477

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis — Active Not Recruiting • Phase III…

📅 21 Jul 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase III
NCT ID
NCT04221477
Start
2020-08-10
Completion
2024-08-15
ClinicaliQ Trial Snapshot
  • A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis — Active Not Recruiting • Phase III • Rheumatology • NCT04221477.
  • A drug called obinutuzumab added to standard lupus kidney treatment improved kidney function and was safe compared to placebo.

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What This Trial Is Studying

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. Conditions: Lupus Nephritis Interventions: Obinutuzumab, MMF, Prednisone, Placebo, Methylprednisolone, Acetaminophen, Diphenhydramine Lead Sponsor: Hoffmann-La Roche Planned Enrollment: 271 participants

Full Trial Details
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Eligibility criteria, protocol, and results when available
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