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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.
First Received: January 24, 2006   Last Updated: September 25, 2008   History of Changes
Sponsor: 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

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

Resource links provided by NLM:


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

  Hide Study Locations
Locations
United States, Alabama
Rheumatology Assoc of North AL
Huntsville, Alabama, United States, 35801
United States, Arizona
Southwest Kidney Inst PLC
Tempe, Arizona, United States, 85284
United States, Arkansas
University of Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Univ of Calif., Los Angeles
Los Angeles, California, United States, 90095
San Leandro Hospital
San Leandro, California, United States, 94578
Stanford Univ School of Med
Palo Alto, California, United States, 94304
Boling Clinical Trials
Upland, California, United States, 91786
Wallace Rheumatic Study Center
Los Angeles, California, United States, 90048
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Arth & Rheumatism Disease Spec
Aventura, Florida, United States, 33180
Arthritis & Sports Care Center
Panama City, Florida, United States, 32405
Family Arthritis Center
Jupiter, Florida, United States, 33458
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Kansas
University of Kansas
Kansas City, Kansas, United States, 66160
United States, Louisiana
LA State Univ Dept of Medicine
Shreveport, Louisiana, United States, 71103
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, New York
Columbia Univ Medical Center
New York, New York, United States, 10032
Hospital for Special Surgery
New York, New York, United States, 10021
NS-LIJ Health System
Lake Success, New York, United States, 11042
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Duke Univ Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oklahoma
Healthcare Res Consultants
Tulsa, Oklahoma, United States, 74135
Oklahoma Med Res Foundation
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
United States, South Carolina
Medical Univ of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Amarillo Ctr for Clin Res LTD
Amarillo, Texas, United States, 79124
Arthritis & Osteoporosis Assoc
Lubbock, Texas, United States, 79424
Southwest Rheumatology
Mesquite, Texas, United States, 75150
Rheumatic Disease Clinic
Houston, Texas, United States, 77004
San Antonio Kidney Disease Cen
San Antonio, Texas, United States, 78212
Metroplex Clin Research Ctr
Dallas, Texas, United States, 75235
Texas Tech University HSC
El Paso, Texas, United States, 79905
Univ of Texas SW Medical Ctr
Dallas, Texas, United States, 75390
Argentina
Centro Medico Priv de Reum
San Miguel, Argentina, T4000AXL
Hosp Italiano de Buenos Aires
Captial Federal, Argentina, C1181ACH
Salisbury Invest Cl�nicas
Quilmes, Argentina, B1878DVB
Hospital Vicente L�pez
San Isidro, Argentina, B1602BPD
OMI
Ciudad Aut�noma, Argentina, C1015ABO
Hospital Privado C�rdoba
C�rdoba Pcia., Argentina, 5016
Brazil
Fundacao Pro Rim
Joinville, SC, Brazil, 89227-680
HC-UFRGS
Porto Alegre, Brazil, 90035-003
Hospital Peral de Goiania
Goiania, Brazil, 74110-120
Hospital Sao Lucas/PURCRS
Porto Alegre, Brazil, 90470-340
Unifesp-Rheumatology
Sao Paulo, Brazil, 04026-000
Unicamp
Campinas, Brazil, 13083-888
Unifesp � Nephrology
Sao Paulo, Brazil, 04039-020
UFGO
Goiania, Brazil, 74605-050
Brazil, SP
Hospital Heli�polis
Sao Paulo, SP, Brazil, 04230-000
Canada, Ontario
Univ Health Network-Toronto
Toronto, Ontario, Canada, M5G 2N
Mexico
Ctro de Inv. del Noreste
Tijuana, Mexico, 22010
Hosp Universitario de Saltillo
Saltillo, Mexico, 25000
Und de Inv en Enf Cro Degen
Guadalajara, Mexico, 44620
Inst. Nac. Salvador Zubiran
M�xico, Mexico, 14000
Hospital Aranda de la Parra
Leon, Guanajuato, Mexico, CP 37000
Sponsors and Collaborators
Genentech
Investigators
Study Director: Jay Garg, M.D Genentech
  More Information

No publications provided

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     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Class IV LN
Lupus
LUNAR
LN

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Glomerulonephritis
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Methylprednisolone
Lupus Nephritis
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Mycophenolic Acid
Antiemetics
Prednisolone acetate
Antibiotics, Antineoplastic
Hormones
Neuroprotective Agents
Lupus Erythematosus, Systemic
Urologic Diseases
Therapeutic Uses
Connective Tissue Diseases
Mycophenolate mofetil
Kidney Diseases
Methylprednisolone Hemisuccinate
Autoimmune Diseases
Antineoplastic Agents, Hormonal
Immune System Diseases
Rituximab
Gastrointestinal Agents
Methylprednisolone acetate
Enzyme Inhibitors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on November 27, 2009