The purpose of this study is to determine whether LJP 394 (abetimus sodium) is safe and effective in delaying and reducing renal flares in patients with lupus nephritis.

Condition	Treatment or Intervention	Phase
Immunologic Diseases Autoimmune Diseases Systemic Lupus Erythematosus Lupus Nephritis Lupus Glomerulonephritis	Drug: Abetimus sodium (LJP 394)	Phase III

Further Study Details: 

Expected Total Enrollment:  330

LJP 394 (abetimus sodium) is a unique drug that is specifically designed to lower production of antibodies to double-stranded DNA. These antibodies are believed to contribute to kidney damage in patients with Systemic Lupus Erythematosus (SLE). Rising levels of these antibodies seem to be associated with exacerbations of kidney disease that are known as "renal flares." Currently, anti-inflammatory and cytotoxic drugs are used to treat renal flares. Unfortunately, these drugs are often associated with certain unpleasant side effects. The purpose of this trial is to determine whether LJP 394 can delay or reduce the number of renal flares. It is possible that if renal flares can be delayed or reduced, patients may be able to take smaller amounts of anti-inflammatory or cytotoxic drugs and therefore suffer fewer of the side effects associated with these treatments.

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

Criteria

Inclusion Criteria

• Diagnosed with SLE
• Historical evidence of SLE renal disease
• Elevated levels of dsDNA antibodies
• Weight of 40 kg or greater

Exclusion Criteria

• Active SLE renal disease
• Use of certain anti-inflammatory or cytotoxic therapies or therapeutic interventions during the months immediately before dosing
• Clinical laboratory test values outside of certain limits
• Malignant disease or immunodeficiency syndrome
• Acute or chronic infections
• History of serious heart disease

Alabama
      Montgomery Rheumatology Associates, Montgomery,  Alabama,  36111,  United States
      University of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States
      Rheumatology Associates of North Alabama, Huntsville,  Alabama,  35801,  United States
      Montgomery Rheumatology Associates, Montgomery,  Alabama,  36111,  United States
Arizona
      Arizona Arthritis & Rheumatology, Paradise Valley,  Arizona,  85253,  United States
California
      Boling Clinical Trials, Rancho Cucamonga,  California,  91730,  United States
      Allergy and Rheumatology Medical Clinic, La Jolla,  California,  92037,  United States
      UCLA School of Medicine, Los Angeles,  California,  90095,  United States
      Harbor-UCLA Research & Education Institute, Medicine/Rheumatology Division, Torrance,  California,  90502,  United States
      Wallace Rheumatic Study Center, Los Angeles,  California,  90048,  United States
      Private Practice, San Mateo,  California,  94401,  United States
      Davida-USC Dialysis Center, Los Angeles,  California,  90033,  United States
      Investigative Clinical Research, Rancho Cucamonga,  California,  91730,  United States
      Private Practice, Los Angeles,  California,  90057,  United States
Connecticut
      Arthritis and Osteoporosis Center, PC, Hamden,  Connecticut,  06518,  United States
      University of Connecticut Health Center, Division of Rheumatology, Farmington,  Connecticut,  06030-1310,  United States
Florida
      CRIA Research, Ft. Lauderdale,  Florida,  33334,  United States
      nTouch Research Corp., St. Petersburg,  Florida,  33707,  United States
Georgia
      Emory University School of Medicine, Renal Division, Atlanta,  Georgia,  30322,  United States
      Private Practice, Macon,  Georgia,  31211,  United States
Idaho
      Radiant Research-Boise, Boise,  Idaho,  83704,  United States
      Intermountain Research Center, Boise,  Idaho,  83702,  United States
Illinois
      University of Chicago, Chicago,  Illinois,  60637,  United States
      Rheumatology Associates, Chicago,  Illinois,  60612,  United States
      Northwestern University, Chicago,  Illinois,  60611,  United States
Indiana
      Rheumatology Associates, PC, Indianapolis,  Indiana,  46260,  United States
      Rheumatology Consultants, Evansville,  Indiana,  47714,  United States
Kentucky
      University of Louisville, Dept of Medicine/Division of Rheumatology, Louisville,  Kentucky,  40292,  United States
Louisiana
      LSU Health Sciences Center, Department of Rheumatology, New Orleans,  Louisiana,  70112-2822,  United States
      Ochsner Clinic, New Orleans,  Louisiana,  70121,  United States
Maryland
      SOMARC, Trials, LLC, Greenbelt,  Maryland,  20770,  United States
      Johns Hopkins University, Baltimore,  Maryland,  21205,  United States
Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States
Michigan
      Wayne State University, Rheumatology Division, Detroit,  Michigan,  48201,  United States
      University of Michigan Health System, Internal Medicine-Rheumatology, Ann Arbor,  Michigan,  48109-0358,  United States
Missouri
      Saint Louis University Health Sciences Center, St. Louis,  Missouri,  63104,  United States
      Washington University, Renal Division, St. Louis,  Missouri,  63110,  United States
New Jersey
      HIS Clinical Trials, Jersey City,  New Jersey,  07306,  United States
New York
      Columbia-Presbyterian Medical Center, New York,  New York,  10032,  United States
      SUNY-Downstate, Brooklyn,  New York,  11203,  United States
      Hospital for Joint Diseases, NYU Medical Center, New York,  New York,  10003,  United States
      Hospital for Joint Diseases, Department of Rheumatology, New York,  New York,  10003,  United States
      AAIR Research Center, Rochester,  New York,  14618,  United States
      NSUH-Division of Rheumatology, Manhasset,  New York,  11030,  United States
      Mt. Sinai Medical Center, New York,  New York,  10029,  United States
      Ambulatory Clinical Research Center, Hospital for Joint Diseases Orthopaedic Institute, NYU, New York,  New York,  10003,  United States
      Nephrology Associates, PC, Flushing,  New York,  11355,  United States
North Carolina
      Wake Forest University School of Medicine, Winston Salem,  North Carolina,  27157,  United States
Ohio
      Metrohealth Medical Center, Division of Rheumatology, Cleveland,  Ohio,  44109,  United States
Oklahoma
      Oklahoma Medical Research Foundation, Oklahoma City,  Oklahoma,  73104,  United States
      Oklahoma State University, Tulsa,  Oklahoma,  74114,  United States
      Healthcare Research Consultants, Tulsa,  Oklahoma,  74135,  United States
Pennsylvania
      Thomas Jefferson University, Division of Rheumatology, Philadelphia,  Pennsylvania,  19107,  United States
      Altoona Center for Clinical Research, Duncansville,  Pennsylvania,  16635,  United States
      University of Pittsburgh, Div. of Rheumatology and Clinical Immun., Pittsburgh,  Pennsylvania,  15261,  United States
South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States
South Dakota
      Dakota Regional Rheumatology, Rapid City,  South Dakota,  57701,  United States
Tennessee
      University of Tennessee, Memphis, Memphis,  Tennessee,  38163,  United States
      Medical Specialty Clinic, Jackson,  Tennessee,  38301,  United States
Texas
      Presbyterian Hospital of Dallas, Arthritis Consultation Center, Dallas,  Texas,  75231-4496,  United States
      Radiant Research - Dallas, Dallas,  Texas,  75235,  United States
      San Antonio Kidney Disease Center, Research Center, San Antonio,  Texas,  78229,  United States
      Texas Tech University Health Sciences Center, Department of Internal Medicine, Lubbock,  Texas,  79430,  United States
Virginia
      Clinical Research and Consulting Center, Fairfax,  Virginia,  22031,  United States
      MedSource, Inc., Richmond,  Virginia,  23229,  United States
Washington
      Arthritis Northwest, Spokane,  Washington,  99204,  United States
Wisconsin
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States
Austria
      Division of Rheumatology, Department of Internal Medicine, Vienna,  A-1090,  Austria
Canada, Ontario
      Arthritis Center of Excellence, Toronto Western Hospital, University Health Network, Toronto,  Ontario,  M5T-2S8,  Canada
Canada, Quebec
      Hospital Maisonnueve-Rosemont, Montreal,  Quebec,  H1T 4B3,  Canada
France
      Service De Rhumatologie Hopital de Hautepierre, Strasbourg Cedex,  67098,  France
Germany
      Universitatklinikum Charite, Medizinische Universitatsklinik, Berlin,  10117,  Germany
      Department for Internal Medicine and Institute of Immunology and Rheumatology, Erlangen,  D-91054,  Germany
      MNR-Klinik/heinrich-Heine-University Dusseldorf, Dusseldorf,  40225,  Germany
Italy
      U.O di Reumatologia, Dipartimento di Medicina Interna, Universita di Pisa, Pisa,  56126,  Italy
Mexico
      Insituto Nacional de Ciencias Medicas Y Nutricion Salvador Zubiran, Depto. de Immunology y Rheumatology, Mexico City,  14000,  Mexico
Spain
      Hospital Universitario La Paz Servico de Medicina, Madrid,  28046,  Spain
      Hospital Clinic y Provinical de Barcelona, Unitat de Malalties Autoimmunes, Barcelona,  08036,  Spain
      Hospital General Valle de Hebron Servicio Medicina Interna. Edificio, Barcelona,  08035,  Spain
Sweden
      Department of Rheumatology, University Hospital of Lund, Lund,  S-22185,  Sweden
      Department of Rheumatology, Karolinska Hospital, Stockholm,  S-17176,  Sweden
United Kingdom
      Rheumatology and Rehabilitation Unit, Leeds,  LS2 3EX,  United Kingdom
      Lupus Research Unit St. Thomas Hospital, The Rayne Institute, London,  SE1 7EH,  United Kingdom

Study ID Numbers:  LJP 394-90-09
Record last reviewed:  December 2002
Last Updated:  October 13, 2004
Record first received:  May 2, 2002
ClinicalTrials.gov Identifier:  NCT00035308
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08