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

NCT04221477

Active Not RecruitingPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Lupus Nephritis

Interventions: Obinutuzumab, MMF, Prednisone, Placebo, Methylprednisolone

Countries: United States, Argentina, Brazil, Colombia, France, Germany, Israel, Italy

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (74)
  • Birmingham, Alabama, United States
  • Beverly Hills, California, United States
  • Fontana, California, United States
  • San Francisco, California, United States
  • Stanford, California, United States
  • Aurora, Colorado, United States
  • New Haven, Connecticut, United States
  • Miami, Florida, United States
  • Lawrenceville, Georgia, United States
  • Manhasset, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • Columbus, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Dallas, Texas, United States
  • Mesquite, Texas, United States
  • Salt Lake City, Utah, United States
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Córdoba, Argentina
  • Salvador, Estado de Bahia, Brazil
  • Curitiba, Paraná, Brazil
  • Ribeirão Preto, São Paulo, Brazil
  • Santo André, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • Barranquilla, Colombia
  • Bogotá, Colombia
  • Medellín, Colombia
  • Créteil, France
  • + 44 more on CT.gov