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A Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With ISN/RPS Class III or IV Lupus Nephritis (LUNAR)
This study is ongoing, but not recruiting participants.
Study NCT00282347.   Last updated on September 25, 2008.
Information provided by Genentech
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A Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With ISN/RPS Class III or IV Lupus Nephritis (LUNAR)
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With ISN/RPS Class III or IV Lupus Nephritis

This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab in combination with MMF compared with placebo in combination with mycophenolate mofetil (MMF) in subjects diagnosed with ISN/RPS 2003 Class III or IV Lupus Nephritis.

Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Proportion of subjects who achieve a renal response [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Change in C3 and C4 complement levels from baseline [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Proportion of subjects who achieve a complete renal response [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Proportion of subjects with a baseline urine protein to creatinine ratio of > 3.0 who achieve a urine protein to creatinine ratio of < 1.0 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Time-adjusted area under the concentration-time curve minus baseline (AUCMB) of BILAG global score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Time to complete renal response [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Change in SLE Expanded Health Survey physical function score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Change in anti-double stranded DNA from baseline [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Lupus Nephritis
Drug: corticosteroids
Drug: methylprednisolone
Drug: mycophenolate mofetil
Drug: placebo
Drug: rituximab
 
Active, not recruiting
140
January 2006

Inclusion Criteria:

  • Diagnosis of SLE according to current ACR criteria
  • Diagnosis of ISN/RPS 2003 Class III or IV LN, with either active or active/chronic disease
  • Proteinuria
  • 16-75 years of age

Exclusion Criteria:

  • Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE
  • Unstable subjects with thrombocytopenia experiencing or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions
  • Lack of peripheral venous access
  • Pregnancy or lactation
  • History of severe allergic or anaphylactic reactions to monoclonal antibodies
  • Significant or uncontrolled medical disease in any organ system not related to SLE or LN, which, in the investigator's opinion, would preclude subject participation
  • Concomitant chronic conditions, excluding SLE (e.g., asthma, Crohn's disease) that require oral or systemic corticosteroid use in the 52 weeks prior to screening
  • History of renal transplant
  • Known HIV infection
  • Known active infection of any kind (but excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous anti-infectives within 4 weeks of randomization or oral anti-infectives within 2 weeks of randomization.
  • History of deep space infection within 1 year of screening
  • History of serious recurrent or chronic infection
  • History of cancer, including solid tumors, hematological malignancies and carcinoma in situ (except basal cell carcinomas of the skin that have been treated or excised and have resolved)
  • Currently active alcohol or drug abuse or history of alcohol or drug abuse within 52 weeks prior to screening
  • Major surgery requiring hospitalization within 4 weeks of screening (excluding diagnostic surgery)
  • Treatment with CYC or calcineurin inhibitors within the 90 days prior to screening
  • Use of MMF at a dose of > 2 grams daily for longer than the 90 days prior to screening
  • Intolerance or history of allergic reaction to MMF
  • Intolerance or history of allergic reaction to both angiotensin-converting enzyme (ACE) inhibitors and angiotensin-receptor blockers
  • Use of oral prednisone (or corticosteroid equivalent) at a dose of > 20 mg/day for longer than the 14 days prior to screening
  • Previous treatment with CAMPATH-1H
  • Previous treatment with a B-cell targeted therapy
  • Treatment with any investigational agent (including biologic agents approved for other indications) within 28 days of the start of the screening period or 5 half-lives of the investigational drug (whichever is longer)
  • Receipt of a live vaccine within the 28 days prior to screening
  • Intolerance or contraindication to oral or IV corticosteroids
  • Current therapy with a nonsteroidal anti-inflammatory agent
  • Positive hepatitis B sAg or hepatitis C serology
Both
16 Years to 75 Years
No
United States,   Argentina,   Brazil,   Canada,   Mexico
 
NCT00282347
U2970g
Genentech
Study Director: Jay Garg, M.D Genentech
Genentech
September 2008
January 24, 2006
September 25, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.