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NCT04221477 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis
A Phase 3 study of Lupus Nephritis, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 271
- Enrollment target
- 20
- Study locations
NCT04221477: Active Phase 3 study of Lupus Nephritis, sponsored by Hoffmann-La Roche.
NCT04221477 is a Phase 3 study of Lupus Nephritis that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 271 participants, below the 301-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04221477, a Phase 3 study of Lupus Nephritis, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 271 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
CRR was defined as an achievement of all the following criteria: urinary protein-to-creatinine ratio (UPCR) \<0.5 gram/gram (g/g); estimated glomerular filtration rate (eGFR) \>=85% of baseline, as calculated using the chronic kidney disease epidemiology collaboration (CKD-EPI) equation and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Obinutuzumab and placebo were compared using Cochran-Mantel-Haenszel (CMH) test adjusting for the st
Conditions Studied
Interventions
- DRUG Obinutuzumab
- DRUG Placebo
- DRUG Prednisone
- DRUG Methylprednisolone
- DRUG MMF
Study Locations (20)
California
- Wallace Rheumatic Study Center - Beverly Hills
- Kaiser Permanente - Fontana - Fontana
- Kaiser Permanente - San Francisco Medical Center - San Francisco
- Stanford University Medical Center - Stanford
New York
- North Shore University Hospital - Manhasset
- NYU Langone Medical Center - New York
- Columbia University Medical Center - New York
- AD-CARE, University of Rochester Medical Center - Rochester
Texas
- University of Texas Southwestern - Dallas
- Southwest Rheumatology - Mesquite
Other
- Organizacion Medica de Investigacion - Buenos Aires
- DOM Centro de Reumatología - Buenos Aires
Alabama
- University of Alabama at Birmingham Medical Center - Birmingham
Colorado
- Univ Colorado Health Sci Ctr - Aurora
Connecticut
- Yale Medical Group - New Haven
Florida
- University of Miami Miller School of Medicine - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 271 participants |
| Start Date | 2020-08-10 |
| Est. Completion | 2031-02-28 |
| Phase | Phase 3 |
What the registry record for NCT04221477 still lists
NCT04221477 is an interventional study that assigns participants to a tested intervention. The registered 271 participants enrollment target is mid-sized for trials with a published cap, below the 301-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (10% lower).
The record links to 1 condition, with Lupus Nephritis appearing as the primary indexed condition, and to 5 interventions - of which Obinutuzumab is the first listed.
NCT04221477 names 20 study sites across 12 states, led by California, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT04221477 about?
NCT04221477 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis". 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 mycop...
What is the current status of trial NCT04221477?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 271 participants. The study started on 2020-08-10. Estimated completion is 2031-02-28.
What conditions does trial NCT04221477 study?
This clinical trial studies the following conditions: Lupus Nephritis.
What interventions are being tested in trial NCT04221477?
The interventions under investigation include: Obinutuzumab (DRUG), Placebo (DRUG), Prednisone (DRUG), Methylprednisolone (DRUG), MMF (DRUG).
Who is sponsoring clinical trial NCT04221477?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04221477 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lupus Nephritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04221477's enrollment target sits among peer trials
271 8th of 30 higher than 23 of 30 other Lupus Nephritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lupus Nephritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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