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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abetimus sodium (LJP 394) | Drug |
Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Rheumatology Associates of North Alabama |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18668592 | Derived | Cardiel MH, Tumlin JA, Furie RA, Wallace DJ, Joh T, Linnik MD; LJP 394-90-09 Investigator Consortium. Abetimus sodium for renal flare in systemic lupus erythematosus: results of a randomized, controlled phase III trial. Arthritis Rheum. 2008 Aug;58(8):2470-80. doi: 10.1002/art.23673. |
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| Huntsville |
| Alabama |
| 35801 |
| United States |
| Montgomery Rheumatology Associates | Montgomery | Alabama | 36111 | United States |
| Arizona Arthritis & Rheumatology | Paradise Valley | Arizona | 85253 | United States |
| Allergy and Rheumatology Medical Clinic | La Jolla | California | 92037 | United States |
| Davida-USC Dialysis Center | Los Angeles | California | 90033 | United States |
| Wallace Rheumatic Study Center | Los Angeles | California | 90048 | United States |
| Private Practice | Los Angeles | California | 90057 | United States |
| UCLA School of Medicine | Los Angeles | California | 90095 | United States |
| Boling Clinical Trials | Rancho Cucamonga | California | 91730 | United States |
| Investigative Clinical Research | Rancho Cucamonga | California | 91730 | United States |
| Private Practice | San Mateo | California | 94401 | United States |
| Harbor-UCLA Research & Education Institute, Medicine/Rheumatology Division | Torrance | California | 90502 | United States |
| University of Connecticut Health Center, Division of Rheumatology | Farmington | Connecticut | 06030-1310 | United States |
| Arthritis and Osteoporosis Center, PC | Hamden | Connecticut | 06518 | United States |
| CRIA Research | Fort Lauderdale | Florida | 33334 | United States |
| nTouch Research Corp. | St. Petersburg | Florida | 33707 | United States |
| Emory University School of Medicine, Renal Division | Atlanta | Georgia | 30322 | United States |
| Private Practice | Macon | Georgia | 31211 | United States |
| Intermountain Research Center | Boise | Idaho | 83702 | United States |
| Radiant Research-Boise | Boise | Idaho | 83704 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Rheumatology Associates | Chicago | Illinois | 60612 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Rheumatology Consultants | Evansville | Indiana | 47714 | United States |
| Rheumatology Associates, PC | Indianapolis | Indiana | 46260 | United States |
| University of Louisville, Dept of Medicine/Division of Rheumatology | Louisville | Kentucky | 40292 | United States |
| LSU Health Sciences Center, Department of Rheumatology | New Orleans | Louisiana | 70112-2822 | United States |
| Ochsner Clinic | New Orleans | Louisiana | 70121 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| SOMARC, Trials, LLC | Greenbelt | Maryland | 20770 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Michigan Health System, Internal Medicine-Rheumatology | Ann Arbor | Michigan | 48109-0358 | United States |
| Wayne State University, Rheumatology Division | Detroit | Michigan | 48201 | United States |
| Saint Louis University Health Sciences Center | St Louis | Missouri | 63104 | United States |
| Washington University, Renal Division | St Louis | Missouri | 63110 | United States |
| HIS Clinical Trials | Jersey City | New Jersey | 07306 | United States |
| SUNY-Downstate | Brooklyn | New York | 11203 | United States |
| Nephrology Associates, PC | Flushing | New York | 11355 | United States |
| NSUH-Division of Rheumatology | Manhasset | New York | 11030 | United States |
| Ambulatory Clinical Research Center, Hospital for Joint Diseases Orthopaedic Institute, NYU | New York | New York | 10003 | United States |
| Hospital for Joint Diseases, Department of Rheumatology | New York | New York | 10003 | United States |
| Hospital for Joint Diseases, NYU Medical Center | New York | New York | 10003 | United States |
| Mt. Sinai Medical Center | New York | New York | 10029 | United States |
| Columbia-Presbyterian Medical Center | New York | New York | 10032 | United States |
| AAIR Research Center | Rochester | New York | 14618 | United States |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| Metrohealth Medical Center, Division of Rheumatology | Cleveland | Ohio | 44109 | United States |
| 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 |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Thomas Jefferson University, Division of Rheumatology | Philadelphia | Pennsylvania | 19107 | United States |
| University of Pittsburgh, Div. of Rheumatology and Clinical Immun. | Pittsburgh | Pennsylvania | 15261 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Dakota Regional Rheumatology | Rapid City | South Dakota | 57701 | United States |
| Medical Specialty Clinic | Jackson | Tennessee | 38301 | United States |
| University of Tennessee, Memphis | Memphis | Tennessee | 38163 | United States |
| Presbyterian Hospital of Dallas, Arthritis Consultation Center | Dallas | Texas | 75231-4496 | United States |
| Radiant Research - Dallas | Dallas | Texas | 75235 | United States |
| Texas Tech University Health Sciences Center, Department of Internal Medicine | Lubbock | Texas | 79430 | United States |
| San Antonio Kidney Disease Center, Research Center | San Antonio | Texas | 78229 | United States |
| Clinical Research and Consulting Center | Fairfax | Virginia | 22031 | United States |
| MedSource, Inc. | Richmond | Virginia | 23229 | United States |
| Arthritis Northwest | Spokane | Washington | 99204 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Division of Rheumatology, Department of Internal Medicine | Vienna | A-1090 | Austria |
| Arthritis Center of Excellence, Toronto Western Hospital, University Health Network | Toronto | Ontario | M5T-2S8 | Canada |
| Hospital Maisonnueve-Rosemont | Montreal | Quebec | H1T 4B3 | Canada |
| Service De Rhumatologie Hopital de Hautepierre | Strasbourg | 67098 | France |
| Universitatklinikum Charite, Medizinische Universitatsklinik | Berlin | 10117 | Germany |
| MNR-Klinik/heinrich-Heine-University Dusseldorf | Düsseldorf | 40225 | Germany |
| Department for Internal Medicine and Institute of Immunology and Rheumatology | Erlangen | D-91054 | Germany |
| U.O di Reumatologia, Dipartimento di Medicina Interna, Universita di Pisa | Pisa | 56126 | Italy |
| Insituto Nacional de Ciencias Medicas Y Nutricion Salvador Zubiran, Depto. de Immunology y Rheumatology | Mexico City | 14000 | Mexico |
| Hospital General Valle de Hebron Servicio Medicina Interna. Edificio | Barcelona | 08035 | Spain |
| Hospital Clinic y Provinical de Barcelona, Unitat de Malalties Autoimmunes | Barcelona | 08036 | Spain |
| Hospital Universitario La Paz Servico de Medicina | Madrid | 28046 | Spain |
| Department of Rheumatology, University Hospital of Lund | Lund | S-22185 | Sweden |
| Department of Rheumatology, Karolinska Hospital | Stockholm | S-17176 | Sweden |
| Rheumatology and Rehabilitation Unit | Leeds | LS2 3EX | United Kingdom |
| Lupus Research Unit St. Thomas Hospital, The Rayne Institute | London | SE1 7EH | United Kingdom |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D001327 | Autoimmune Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C094104 | abetimus |
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