Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease
- Conditions
- Immunologic DiseasesAutoimmune DiseasesSystemic Lupus ErythematosusLupus NephritisLupus Glomerulonephritis
- Registration Number
- NCT00035308
- Lead Sponsor
- La Jolla Pharmaceutical Company
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (80)
Emory University School of Medicine, Renal Division
🇺🇸Atlanta, Georgia, United States
Rheumatology Associates
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Pittsburgh, Div. of Rheumatology and Clinical Immun.
🇺🇸Pittsburgh, Pennsylvania, United States
Radiant Research - Dallas
🇺🇸Dallas, Texas, United States
Rheumatology Associates, PC
🇺🇸Indianapolis, Indiana, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Metrohealth Medical Center, Division of Rheumatology
🇺🇸Cleveland, Ohio, United States
Oklahoma State University
🇺🇸Tulsa, Oklahoma, United States
LSU Health Sciences Center, Department of Rheumatology
🇺🇸New Orleans, Louisiana, United States
University of Tennessee, Memphis
🇺🇸Memphis, Tennessee, United States
Arthritis and Osteoporosis Center, PC
🇺🇸Hamden, Connecticut, United States
Insituto Nacional de Ciencias Medicas Y Nutricion Salvador Zubiran, Depto. de Immunology y Rheumatology
🇲🇽Mexico City, Mexico
Hospital for Joint Diseases, Department of Rheumatology
🇺🇸New York, New York, United States
Mt. Sinai Medical Center
🇺🇸New York, New York, United States
Boling Clinical Trials
🇺🇸Rancho Cucamonga, California, United States
Washington University, Renal Division
🇺🇸St. Louis, Missouri, United States
Arizona Arthritis & Rheumatology
🇺🇸Paradise Valley, Arizona, United States
Nephrology Associates, PC
🇺🇸Flushing, New York, United States
Medical Specialty Clinic
🇺🇸Jackson, Tennessee, United States
MedSource, Inc.
🇺🇸Richmond, Virginia, United States
Arthritis Northwest
🇺🇸Spokane, Washington, United States
Service De Rhumatologie Hopital de Hautepierre
🇫🇷Strasbourg Cedex, France
Arthritis Center of Excellence, Toronto Western Hospital, University Health Network
🇨🇦Toronto, Ontario, Canada
Hospital Maisonnueve-Rosemont
🇨🇦Montreal, Quebec, Canada
MNR-Klinik/heinrich-Heine-University Dusseldorf
🇩🇪Dusseldorf, Germany
Department of Rheumatology, University Hospital of Lund
🇸🇪Lund, Sweden
Department of Rheumatology, Karolinska Hospital
🇸🇪Stockholm, Sweden
Rheumatology and Rehabilitation Unit
🇬🇧Leeds, United Kingdom
Montgomery Rheumatology Associates
🇺🇸Montgomery, Alabama, United States
Rheumatology Associates of North Alabama
🇺🇸Huntsville, Alabama, United States
Davida-USC Dialysis Center
🇺🇸Los Angeles, California, United States
Wallace Rheumatic Study Center
🇺🇸Los Angeles, California, United States
Allergy and Rheumatology Medical Clinic
🇺🇸La Jolla, California, United States
UCLA School of Medicine
🇺🇸Los Angeles, California, United States
Private Practice
🇺🇸Macon, Georgia, United States
Intermountain Research Center
🇺🇸Boise, Idaho, United States
Investigative Clinical Research
🇺🇸Rancho Cucamonga, California, United States
nTouch Research Corp.
🇺🇸St. Petersburg, Florida, United States
University of Connecticut Health Center, Division of Rheumatology
🇺🇸Farmington, Connecticut, United States
CRIA Research
🇺🇸Ft. Lauderdale, Florida, United States
Harbor-UCLA Research & Education Institute, Medicine/Rheumatology Division
🇺🇸Torrance, California, United States
Radiant Research-Boise
🇺🇸Boise, Idaho, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Rheumatology Consultants
🇺🇸Evansville, Indiana, United States
Ochsner Clinic
🇺🇸New Orleans, Louisiana, United States
SOMARC, Trials, LLC
🇺🇸Greenbelt, Maryland, United States
Saint Louis University Health Sciences Center
🇺🇸St. Louis, Missouri, United States
HIS Clinical Trials
🇺🇸Jersey City, New Jersey, United States
SUNY-Downstate
🇺🇸Brooklyn, New York, United States
NSUH-Division of Rheumatology
🇺🇸Manhasset, New York, United States
Columbia-Presbyterian Medical Center
🇺🇸New York, New York, United States
Ambulatory Clinical Research Center, Hospital for Joint Diseases Orthopaedic Institute, NYU
🇺🇸New York, New York, United States
Hospital for Joint Diseases, NYU Medical Center
🇺🇸New York, New York, United States
AAIR Research Center
🇺🇸Rochester, New York, United States
Wake Forest University School of Medicine
🇺🇸Winston Salem, North Carolina, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Thomas Jefferson University, Division of Rheumatology
🇺🇸Philadelphia, Pennsylvania, United States
Healthcare Research Consultants
🇺🇸Tulsa, Oklahoma, United States
Dakota Regional Rheumatology
🇺🇸Rapid City, South Dakota, United States
Texas Tech University Health Sciences Center, Department of Internal Medicine
🇺🇸Lubbock, Texas, United States
Presbyterian Hospital of Dallas, Arthritis Consultation Center
🇺🇸Dallas, Texas, United States
Division of Rheumatology, Department of Internal Medicine
🇦🇹Vienna, Austria
Clinical Research and Consulting Center
🇺🇸Fairfax, Virginia, United States
Department for Internal Medicine and Institute of Immunology and Rheumatology
🇩🇪Erlangen, Germany
U.O di Reumatologia, Dipartimento di Medicina Interna, Universita di Pisa
🇮🇹Pisa, Italy
Universitatklinikum Charite, Medizinische Universitatsklinik
🇩🇪Berlin, Germany
Hospital General Valle de Hebron Servicio Medicina Interna. Edificio
🇪🇸Barcelona, Spain
Lupus Research Unit St. Thomas Hospital, The Rayne Institute
🇬🇧London, United Kingdom
Hospital Clinic y Provinical de Barcelona, Unitat de Malalties Autoimmunes
🇪🇸Barcelona, Spain
Hospital Universitario La Paz Servico de Medicina
🇪🇸Madrid, Spain
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Louisville, Dept of Medicine/Division of Rheumatology
🇺🇸Louisville, Kentucky, United States
University of Michigan Health System, Internal Medicine-Rheumatology
🇺🇸Ann Arbor, Michigan, United States
Wayne State University, Rheumatology Division
🇺🇸Detroit, Michigan, United States
Oklahoma Medical Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
San Antonio Kidney Disease Center, Research Center
🇺🇸San Antonio, Texas, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States