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| Sponsor: | La Jolla Pharmaceutical Company |
|---|---|
| Information provided by: | La Jolla Pharmaceutical Company |
| ClinicalTrials.gov Identifier: | NCT00035308 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Immunologic Diseases Autoimmune Diseases Systemic Lupus Erythematosus Lupus Nephritis Lupus Glomerulonephritis |
Drug: Abetimus sodium (LJP 394) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Safety and Efficacy Trial of LJP 394 in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease |
| Estimated Enrollment: | 330 |
| Estimated Study Completion Date: | December 2002 |
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.
Eligibility| Ages Eligible for Study: | 12 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Montgomery Rheumatology Associates | |
| Montgomery, Alabama, United States, 36111 | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| Rheumatology Associates of North Alabama | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Arizona Arthritis & Rheumatology | |
| Paradise Valley, Arizona, United States, 85253 | |
| United States, California | |
| Boling Clinical Trials | |
| Rancho Cucamonga, California, United States, 91730 | |
| Private Practice | |
| San Mateo, California, United States, 94401 | |
| UCLA School of Medicine | |
| Los Angeles, California, United States, 90095 | |
| Harbor-UCLA Research & Education Institute, Medicine/Rheumatology Division | |
| Torrance, California, United States, 90502 | |
| Wallace Rheumatic Study Center | |
| Los Angeles, California, United States, 90048 | |
| Allergy and Rheumatology Medical Clinic | |
| La Jolla, California, United States, 92037 | |
| Davida-USC Dialysis Center | |
| Los Angeles, California, United States, 90033 | |
| Investigative Clinical Research | |
| Rancho Cucamonga, California, United States, 91730 | |
| Private Practice | |
| Los Angeles, California, United States, 90057 | |
| United States, Connecticut | |
| Arthritis and Osteoporosis Center, PC | |
| Hamden, Connecticut, United States, 06518 | |
| University of Connecticut Health Center, Division of Rheumatology | |
| Farmington, Connecticut, United States, 06030-1310 | |
| United States, Florida | |
| CRIA Research | |
| Ft. Lauderdale, Florida, United States, 33334 | |
| nTouch Research Corp. | |
| St. Petersburg, Florida, United States, 33707 | |
| United States, Georgia | |
| Emory University School of Medicine, Renal Division | |
| Atlanta, Georgia, United States, 30322 | |
| Private Practice | |
| Macon, Georgia, United States, 31211 | |
| United States, Idaho | |
| Radiant Research-Boise | |
| Boise, Idaho, United States, 83704 | |
| Intermountain Research Center | |
| Boise, Idaho, United States, 83702 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| Rheumatology Associates | |
| Chicago, Illinois, United States, 60612 | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Rheumatology Associates, PC | |
| Indianapolis, Indiana, United States, 46260 | |
| Rheumatology Consultants | |
| Evansville, Indiana, United States, 47714 | |
| United States, Kentucky | |
| University of Louisville, Dept of Medicine/Division of Rheumatology | |
| Louisville, Kentucky, United States, 40292 | |
| United States, Louisiana | |
| LSU Health Sciences Center, Department of Rheumatology | |
| New Orleans, Louisiana, United States, 70112-2822 | |
| Ochsner Clinic | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maryland | |
| SOMARC, Trials, LLC | |
| Greenbelt, Maryland, United States, 20770 | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| Wayne State University, Rheumatology Division | |
| Detroit, Michigan, United States, 48201 | |
| University of Michigan Health System, Internal Medicine-Rheumatology | |
| Ann Arbor, Michigan, United States, 48109-0358 | |
| United States, Missouri | |
| Saint Louis University Health Sciences Center | |
| St. Louis, Missouri, United States, 63104 | |
| Washington University, Renal Division | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| HIS Clinical Trials | |
| Jersey City, New Jersey, United States, 07306 | |
| United States, New York | |
| Columbia-Presbyterian Medical Center | |
| New York, New York, United States, 10032 | |
| SUNY-Downstate | |
| Brooklyn, New York, United States, 11203 | |
| Hospital for Joint Diseases, NYU Medical Center | |
| New York, New York, United States, 10003 | |
| Hospital for Joint Diseases, Department of Rheumatology | |
| New York, New York, United States, 10003 | |
| AAIR Research Center | |
| Rochester, New York, United States, 14618 | |
| NSUH-Division of Rheumatology | |
| Manhasset, New York, United States, 11030 | |
| Mt. Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| Ambulatory Clinical Research Center, Hospital for Joint Diseases Orthopaedic Institute, NYU | |
| New York, New York, United States, 10003 | |
| Nephrology Associates, PC | |
| Flushing, New York, United States, 11355 | |
| United States, North Carolina | |
| Wake Forest University School of Medicine | |
| Winston Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Metrohealth Medical Center, Division of Rheumatology | |
| Cleveland, Ohio, United States, 44109 | |
| United States, Oklahoma | |
| Oklahoma Medical Research Foundation | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Oklahoma State University | |
| Tulsa, Oklahoma, United States, 74114 | |
| Healthcare Research Consultants | |
| Tulsa, Oklahoma, United States, 74135 | |
| United States, Pennsylvania | |
| Thomas Jefferson University, Division of Rheumatology | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Altoona Center for Clinical Research | |
| Duncansville, Pennsylvania, United States, 16635 | |
| University of Pittsburgh, Div. of Rheumatology and Clinical Immun. | |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, South Dakota | |
| Dakota Regional Rheumatology | |
| Rapid City, South Dakota, United States, 57701 | |
| United States, Tennessee | |
| University of Tennessee, Memphis | |
| Memphis, Tennessee, United States, 38163 | |
| Medical Specialty Clinic | |
| Jackson, Tennessee, United States, 38301 | |
| United States, Texas | |
| Presbyterian Hospital of Dallas, Arthritis Consultation Center | |
| Dallas, Texas, United States, 75231-4496 | |
| Radiant Research - Dallas | |
| Dallas, Texas, United States, 75235 | |
| San Antonio Kidney Disease Center, Research Center | |
| San Antonio, Texas, United States, 78229 | |
| Texas Tech University Health Sciences Center, Department of Internal Medicine | |
| Lubbock, Texas, United States, 79430 | |
| United States, Virginia | |
| Clinical Research and Consulting Center | |
| Fairfax, Virginia, United States, 22031 | |
| MedSource, Inc. | |
| Richmond, Virginia, United States, 23229 | |
| United States, Washington | |
| Arthritis Northwest | |
| Spokane, Washington, United States, 99204 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Austria | |
| Division of Rheumatology, Department of Internal Medicine | |
| Vienna, Austria, A-1090 | |
| Canada, Ontario | |
| Arthritis Center of Excellence, Toronto Western Hospital, University Health Network | |
| Toronto, Ontario, Canada, M5T-2S8 | |
| Canada, Quebec | |
| Hospital Maisonnueve-Rosemont | |
| Montreal, Quebec, Canada, H1T 4B3 | |
| France | |
| Service De Rhumatologie Hopital de Hautepierre | |
| Strasbourg Cedex, France, 67098 | |
| Germany | |
| Universitatklinikum Charite, Medizinische Universitatsklinik | |
| Berlin, Germany, 10117 | |
| Department for Internal Medicine and Institute of Immunology and Rheumatology | |
| Erlangen, Germany, D-91054 | |
| MNR-Klinik/heinrich-Heine-University Dusseldorf | |
| Dusseldorf, Germany, 40225 | |
| Italy | |
| U.O di Reumatologia, Dipartimento di Medicina Interna, Universita di Pisa | |
| Pisa, Italy, 56126 | |
| Mexico | |
| Insituto Nacional de Ciencias Medicas Y Nutricion Salvador Zubiran, Depto. de Immunology y Rheumatology | |
| Mexico City, Mexico, 14000 | |
| Spain | |
| Hospital Universitario La Paz Servico de Medicina | |
| Madrid, Spain, 28046 | |
| Hospital Clinic y Provinical de Barcelona, Unitat de Malalties Autoimmunes | |
| Barcelona, Spain, 08036 | |
| Hospital General Valle de Hebron Servicio Medicina Interna. Edificio | |
| Barcelona, Spain, 08035 | |
| Sweden | |
| Department of Rheumatology, University Hospital of Lund | |
| Lund, Sweden, S-22185 | |
| Department of Rheumatology, Karolinska Hospital | |
| Stockholm, Sweden, S-17176 | |
| United Kingdom | |
| Rheumatology and Rehabilitation Unit | |
| Leeds, United Kingdom, LS2 3EX | |
| Lupus Research Unit St. Thomas Hospital, The Rayne Institute | |
| London, United Kingdom, SE1 7EH | |
More Information
| Study ID Numbers: | LJP 394-90-09 |
| Study First Received: | May 2, 2002 |
| Last Updated: | September 22, 2006 |
| ClinicalTrials.gov Identifier: | NCT00035308 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Immunologic Diseases Autoimmune Diseases Systemic Lupus Erythematosus |
SLE Lupus Nephritis Lupus Glomerulonephritis |
|
Glomerulonephritis Autoimmune Diseases Urologic Diseases Lupus Erythematosus, Systemic Immune System Diseases |
Lupus Nephritis Nephritis Connective Tissue Diseases Kidney Diseases |
