The primary purpose of this study is to determine whether LJP 394 is more effective than placebo in delaying time to renal flare in SLE patients with a history of renal disease.

Condition	Treatment or Intervention	Phase
Lupus Erythematosus, Systemic Lupus Nephritis	Drug: abetimus sodium (LJP 394)	Phase III

Further Study Details: 

Expected Total Enrollment:  509

Ages Eligible for Study:  12 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Diagnosis of Systemic Lupus Erythematosus (SLE)
• Active SLE renal disease within past 4 years.
• Males or females between 12 and 70 years old.
• Females must be non-pregnant and non-lactating. Females and males must use adequate birth control methods during course of study.
• Ability to have weekly intravenous (IV) administration of study treatment.

Exclusion Criteria:

• Active SLE renal disease within past 3 months prior to entering study.
• Use of the following therapies within 3 months prior to entering the study: alkylating agents, e.g., cyclophosphamide, TNF inhibitors, cyclosporine.
• Use of mycophenolate mofetil that exceeds 1000 mg/day, azathioprine that exceeds 100 mg/day, methotrexate that exceed 10 mg/week, leflunomide that exceeds 10 mg/day within 3 months prior to entering study.
• Use of rituximab within 5 months prior to entering study.
• Current abuse of drugs or alcohol.

Alabama
      Montgomery Rheumatology Associates, Montgomery,  Alabama,  36111,  United States
      Rheumatology Associates of North America, Huntsville,  Alabama,  35801,  United States
      University of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States
Arizona
      Arizona Arthritis Research, PLC, Paradise Valley,  Arizona,  85253,  United States
California
      Allergy and Rheumatology Medical Clinic, La Jolla,  California,  92037,  United States
      Private Practice, San Mateo,  California,  94401,  United States
      Wallace Rheumatic Study Center, Los Angeles,  California,  90048,  United States
      East Bay Rheumatology Medical Group, San Leandro,  California,  94578,  United States
Connecticut
      Arthritis and Osteoporosis Center, PC, Hamden,  Connecticut,  06518,  United States
Florida
      CRIA Research, Fort Lauderdale,  Florida,  33334,  United States
      Geodessey Research, LLC, Vero Beach,  Florida,  32962,  United States
      Miami Children's Hospital, Miami,  Florida,  33155,  United States
Georgia
      Nephrology & Hypertension, Atlanta,  Georgia,  30342,  United States
      Private Practice, Augusta,  Georgia,  30904,  United States
      Emory University School of Medicine, Renal Division, Atlanta,  Georgia,  30322,  United States
Idaho
      Intermountain Orthopedics, Boise,  Idaho,  83702,  United States
Illinois
      Rheumatology Associates, Chicago,  Illinois,  60612,  United States
Indiana
      TriState Arthritis & Rheumatology Center, LLC, Evansville,  Indiana,  47714,  United States
Louisiana
      Ochsner Clinic Foundation, New Orleans,  Louisiana,  70121,  United States
Maryland
      SOMARC Trials, LLC, Greenbelt,  Maryland,  20770,  United States
Missouri
      Washington University School of Medicine, St. Louis,  Missouri,  63110,  United States
New York
      AAIR Research Center, Rochester,  New York,  14618,  United States
      Nephrology Associates, PC, Flushing,  New York,  11355,  United States
      North Shore - LIJ Health System, Lake Success,  New York,  11042,  United States
      Seligan Center for Advanced Therapeutics, NYU Hospital for Joint Disease, New York,  New York,  10003,  United States
      Columbia Presbyterian Medical Center, New York,  New York,  10032,  United States
North Carolina
      Wake Forest University Health Sciences, Winston Salem,  North Carolina,  27157,  United States
Ohio
      Ohio State University Medical Center, Columbus,  Ohio,  43210,  United States
Oklahoma
      Healthcare Research Consultants, Tulsa,  Oklahoma,  74135,  United States
      Oklahoma Center for Arthritis Therapy & Research, Inc., Tulsa,  Oklahoma,  74114,  United States
Pennsylvania
      Altoona Center for Clinical Research, Duncansville,  Pennsylvania,  16635,  United States
      Private Practice, Camp Hill,  Pennsylvania,  17011,  United States
      Thomas Jefferson University, Philadelphia,  Pennsylvania,  19131,  United States
Texas
      San Antonio Kidney Disease Center, San Antonio,  Texas,  78229,  United States
      Texas Tech University Health Sciences Center, Lubbock,  Texas,  79430,  United States
      Amarillo Center for Clinical Research, Amarillo,  Texas,  79124,  United States
Virginia
      Clinical Research & Consulting Center, Fairfax,  Virginia,  22030,  United States
Washington
      Arthritis Northwest PLLC, Spokane,  Washington,  99204,  United States

Study ID Numbers:  LJP 394-90-14
Record last reviewed:  April 2005
Last Updated:  April 5, 2005
Record first received:  August 13, 2004
ClinicalTrials.gov Identifier:  NCT00089804
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08