Lupus Nephritis - Vandalia OH (Metro Dayton)

Summary:

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This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.

--Must have 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

--Must have a urine protein to creatinine ratio greater than or equal to (>/=) 1 on a 24-hour collection

--Must not have severe renal impairment or the need for dialysis or renal transplantation

--Must not have a known active infection of any kind or recent major episode of infection

--Must not have 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

Qualified Participants May Receive:

STAT Research will cover the cost of any trial related medical examinations and labs. 

Qualified participants will be monitored and cared for during the course of the study by our professional staff and physicians. 

No insurance is required.