A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis
Public ClinicalTrials.gov record NCT04221477. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04221477
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 271 participants
Conditions and interventions
Conditions
Interventions
- Obinutuzumab Drug
- MMF Drug
- Prednisone Drug
- Placebo Drug
- Methylprednisolone Drug
- Acetaminophen Drug
- Diphenhydramine Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 10, 2020 (Actual)
- Primary completion
- Aug 15, 2024 (Actual)
- Completion
- Mar 2, 2031 (Estimated)
- Last update posted
- Oct 19, 2026
2020 – 2031
United States locations
- U.S. sites
- 18
- U.S. states
- 11
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Medical Center | Birmingham | Alabama | 35233 | — |
| Wallace Rheumatic Study Center | Beverly Hills | California | 90211 | — |
| Kaiser Permanente - Fontana | Fontana | California | 92335 | — |
| Kaiser Permanente - San Francisco Medical Center | San Francisco | California | 94118 | — |
| Stanford University Medical Center | Stanford | California | 94305 | — |
| Univ Colorado Health Sci Ctr | Aurora | Colorado | 80045 | — |
| Yale Medical Group | New Haven | Connecticut | 06520 | — |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | — |
| Georgia Nephrology | Lawrenceville | Georgia | 30046 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| NYU Langone Medical Center | New York | New York | 10016 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| AD-CARE, University of Rochester Medical Center | Rochester | New York | 14620 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43212 | — |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | — |
| University of Texas Southwestern | Dallas | Texas | 75390-8897 | — |
| Southwest Rheumatology | Mesquite | Texas | 75150 | — |
| University of Utah Health Science center | Salt Lake City | Utah | 84113 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 56 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04221477, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 19, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04221477 live on ClinicalTrials.gov.