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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.
Sponsored by: Genentech
Information provided by: Genentech
ClinicalTrials.gov Identifier: NCT00282347
  Purpose

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.


Condition Intervention Phase
Lupus Nephritis
Drug: corticosteroids
Drug: methylprednisolone
Drug: mycophenolate mofetil
Drug: placebo
Drug: rituximab
Phase III

Drug Information available for: Methylprednisolone Rituximab Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Corticosteroids
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title: 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

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Proportion of subjects who achieve a renal response [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 140
Study Start Date: January 2006
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: corticosteroids
Intravenous or oral repeating dose
Drug: methylprednisolone
Intravenous repeating dose
Drug: mycophenolate mofetil
Intravenous repeating dose
Drug: rituximab
Intravenous repeating dose
2: Placebo Comparator Drug: corticosteroids
Intravenous or oral repeating dose
Drug: methylprednisolone
Intravenous repeating dose
Drug: mycophenolate mofetil
Intravenous repeating dose
Drug: placebo
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282347

  Show 61 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Jay Garg, M.D Genentech
  More Information

Responsible Party: Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers: U2970g
Study First Received: January 24, 2006
Last Updated: September 25, 2008
ClinicalTrials.gov Identifier: NCT00282347  
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Class IV LN
Lupus
LUNAR
LN

Study placed in the following topic categories:
Glomerulonephritis
Autoimmune Diseases
Lupus Nephritis
Rituximab
Methylprednisolone
Methylprednisolone acetate
Prednisolone acetate
Urologic Diseases
Lupus Erythematosus, Systemic
Nephritis
Prednisolone
Connective Tissue Diseases
Mycophenolate mofetil
Kidney Diseases
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immunologic Factors
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Immunosuppressive Agents
Hormones
Neuroprotective Agents
Protective Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009