A Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV Lupus Nephritis

Sponsor
Genentech, Inc.
Study ID
NCT00282347
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab was provided as a sterile solution for injection.
  • Placebo — DRUG
    Placebo was provided as a sterile solution for injection.
  • Mycophenolate mofetil — DRUG
  • Methylprednisolone — DRUG
  • Diphenhydramine — DRUG
  • Acetaminophen — DRUG
  • Prednisone — DRUG

Study Details

This was a Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab in combination with mycophenolate mofetil (MMF) compared with placebo in combination with MMF in subjects diagnosed with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis.

Key Dates

Start date
Jan 31, 2006
Status verified
Jan 2015
Primary completion
Jan 31, 2009
Completion
Jan 31, 2013

Study Design

Enrollment
144 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
  • Placebo Comparator: Placebo
    Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.

Primary Outcome Measure

Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52 [ Time Frame: Week 52 ]

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