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Active Not Recruiting
NCT04221477
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis
Conditions: Lupus Nephritis
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 271
Sponsor: Hoffmann-La Roche
Location: University of Alabama at Birmingham Medical Center Birmingham Alabama
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.
Eligibility Criteria
Key Inclusion Criteria:
* Diagnosis of active or active/chronic ISN/RPS 2003 Class III or IV proliferative LN as evidenced by renal biopsy performed within 6 months. Participants may co-exhibit Class V disease in addition to either Class III or Class IV disease
* Urine protein to creatinine ratio greater than or equal to (\>/=) 1 on a 24-hour collection
* Other inclusion criteria may apply
Key Exclusion Criteria:
* Pregnancy or breastfeeding
* Severe renal impairment or the need for dialysis or renal transplantation
* Receipt of an excluded therapy, including any anti-CD20 therapy less than 9 months prior to screening or during screening; or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening
* Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude participant participation
* Known active infection of any kind or recent major episode of infection
* Intolerance or contraindication to study therapies
* Other exclusion criteria may apply
Source: ClinicalTrials.gov (NCT04221477). StuddyBuddy aggregates publicly available trial information.