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

ClinicalTrials.gov ID: NCT04221477

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.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced May 19, 2026, 7:49 PM EDT

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

Study identification

NCT ID: NCT04221477
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 271 participants

Conditions and interventions

Conditions

Lupus Nephritis

Interventions

Acetaminophen Drug
Diphenhydramine Drug
MMF Drug
Methylprednisolone Drug
Obinutuzumab Drug
Placebo Drug
Prednisone 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 9, 2020
Primary completion: Aug 14, 2024
Completion: Mar 1, 2031
Last update posted: May 10, 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 May 10, 2026 · Synced May 19, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04221477 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →