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A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients 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 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.

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Obinutuzumab
  • drug: MMF
  • drug: Prednisone
  • drug: Placebo
  • drug: Methylprednisolone
  • drug: Acetaminophen
  • drug: Diphenhydramine

Eligibility


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 patient participation

   - Known active infection of any kind or recent major episode of infection

   - Intolerance or contraindication to study therapies

   - Other exclusion criteria may apply

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elizabeth Chen
(650) 721-3848
Not Recruiting