Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease
Sponsor
La Jolla Pharmaceutical Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00035308
Collaborator
(none)
330
82
4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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
Study Completion Date
:
Dec 1, 2002
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
| 2 | Rheumatology Associates of North Alabama | Huntsville | Alabama | United States | 35801 |
| 3 | Montgomery Rheumatology Associates | Montgomery | Alabama | United States | 36111 |
| 4 | Arizona Arthritis & Rheumatology | Paradise Valley | Arizona | United States | 85253 |
| 5 | Allergy and Rheumatology Medical Clinic | La Jolla | California | United States | 92037 |
| 6 | Davida-USC Dialysis Center | Los Angeles | California | United States | 90033 |
| 7 | Wallace Rheumatic Study Center | Los Angeles | California | United States | 90048 |
| 8 | Private Practice | Los Angeles | California | United States | 90057 |
| 9 | UCLA School of Medicine | Los Angeles | California | United States | 90095 |
| 10 | Boling Clinical Trials | Rancho Cucamonga | California | United States | 91730 |
| 11 | Investigative Clinical Research | Rancho Cucamonga | California | United States | 91730 |
| 12 | Private Practice | San Mateo | California | United States | 94401 |
| 13 | Harbor-UCLA Research & Education Institute, Medicine/Rheumatology Division | Torrance | California | United States | 90502 |
| 14 | University of Connecticut Health Center, Division of Rheumatology | Farmington | Connecticut | United States | 06030-1310 |
| 15 | Arthritis and Osteoporosis Center, PC | Hamden | Connecticut | United States | 06518 |
| 16 | CRIA Research | Ft. Lauderdale | Florida | United States | 33334 |
| 17 | nTouch Research Corp. | St. Petersburg | Florida | United States | 33707 |
| 18 | Emory University School of Medicine, Renal Division | Atlanta | Georgia | United States | 30322 |
| 19 | Private Practice | Macon | Georgia | United States | 31211 |
| 20 | Intermountain Research Center | Boise | Idaho | United States | 83702 |
| 21 | Radiant Research-Boise | Boise | Idaho | United States | 83704 |
| 22 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 23 | Rheumatology Associates | Chicago | Illinois | United States | 60612 |
| 24 | University of Chicago | Chicago | Illinois | United States | 60637 |
| 25 | Rheumatology Consultants | Evansville | Indiana | United States | 47714 |
| 26 | Rheumatology Associates, PC | Indianapolis | Indiana | United States | 46260 |
| 27 | University of Louisville, Dept of Medicine/Division of Rheumatology | Louisville | Kentucky | United States | 40292 |
| 28 | LSU Health Sciences Center, Department of Rheumatology | New Orleans | Louisiana | United States | 70112-2822 |
| 29 | Ochsner Clinic | New Orleans | Louisiana | United States | 70121 |
| 30 | Johns Hopkins University | Baltimore | Maryland | United States | 21205 |
| 31 | SOMARC, Trials, LLC | Greenbelt | Maryland | United States | 20770 |
| 32 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 33 | University of Michigan Health System, Internal Medicine-Rheumatology | Ann Arbor | Michigan | United States | 48109-0358 |
| 34 | Wayne State University, Rheumatology Division | Detroit | Michigan | United States | 48201 |
| 35 | Saint Louis University Health Sciences Center | St. Louis | Missouri | United States | 63104 |
| 36 | Washington University, Renal Division | St. Louis | Missouri | United States | 63110 |
| 37 | HIS Clinical Trials | Jersey City | New Jersey | United States | 07306 |
| 38 | SUNY-Downstate | Brooklyn | New York | United States | 11203 |
| 39 | Nephrology Associates, PC | Flushing | New York | United States | 11355 |
| 40 | NSUH-Division of Rheumatology | Manhasset | New York | United States | 11030 |
| 41 | Ambulatory Clinical Research Center, Hospital for Joint Diseases Orthopaedic Institute, NYU | New York | New York | United States | 10003 |
| 42 | Hospital for Joint Diseases, Department of Rheumatology | New York | New York | United States | 10003 |
| 43 | Hospital for Joint Diseases, NYU Medical Center | New York | New York | United States | 10003 |
| 44 | Mt. Sinai Medical Center | New York | New York | United States | 10029 |
| 45 | Columbia-Presbyterian Medical Center | New York | New York | United States | 10032 |
| 46 | AAIR Research Center | Rochester | New York | United States | 14618 |
| 47 | Wake Forest University School of Medicine | Winston Salem | North Carolina | United States | 27157 |
| 48 | Metrohealth Medical Center, Division of Rheumatology | Cleveland | Ohio | United States | 44109 |
| 49 | Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | United States | 73104 |
| 50 | Oklahoma State University | Tulsa | Oklahoma | United States | 74114 |
| 51 | Healthcare Research Consultants | Tulsa | Oklahoma | United States | 74135 |
| 52 | Altoona Center for Clinical Research | Duncansville | Pennsylvania | United States | 16635 |
| 53 | Thomas Jefferson University, Division of Rheumatology | Philadelphia | Pennsylvania | United States | 19107 |
| 54 | University of Pittsburgh, Div. of Rheumatology and Clinical Immun. | Pittsburgh | Pennsylvania | United States | 15261 |
| 55 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 56 | Dakota Regional Rheumatology | Rapid City | South Dakota | United States | 57701 |
| 57 | Medical Specialty Clinic | Jackson | Tennessee | United States | 38301 |
| 58 | University of Tennessee, Memphis | Memphis | Tennessee | United States | 38163 |
| 59 | Presbyterian Hospital of Dallas, Arthritis Consultation Center | Dallas | Texas | United States | 75231-4496 |
| 60 | Radiant Research - Dallas | Dallas | Texas | United States | 75235 |
| 61 | Texas Tech University Health Sciences Center, Department of Internal Medicine | Lubbock | Texas | United States | 79430 |
| 62 | San Antonio Kidney Disease Center, Research Center | San Antonio | Texas | United States | 78229 |
| 63 | Clinical Research and Consulting Center | Fairfax | Virginia | United States | 22031 |
| 64 | MedSource, Inc. | Richmond | Virginia | United States | 23229 |
| 65 | Arthritis Northwest | Spokane | Washington | United States | 99204 |
| 66 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 67 | Division of Rheumatology, Department of Internal Medicine | Vienna | Austria | A-1090 | |
| 68 | Arthritis Center of Excellence, Toronto Western Hospital, University Health Network | Toronto | Ontario | Canada | M5T-2S8 |
| 69 | Hospital Maisonnueve-Rosemont | Montreal | Quebec | Canada | H1T 4B3 |
| 70 | Service De Rhumatologie Hopital de Hautepierre | Strasbourg Cedex | France | 67098 | |
| 71 | Universitatklinikum Charite, Medizinische Universitatsklinik | Berlin | Germany | 10117 | |
| 72 | MNR-Klinik/heinrich-Heine-University Dusseldorf | Dusseldorf | Germany | 40225 | |
| 73 | Department for Internal Medicine and Institute of Immunology and Rheumatology | Erlangen | Germany | D-91054 | |
| 74 | U.O di Reumatologia, Dipartimento di Medicina Interna, Universita di Pisa | Pisa | Italy | 56126 | |
| 75 | Insituto Nacional de Ciencias Medicas Y Nutricion Salvador Zubiran, Depto. de Immunology y Rheumatology | Mexico City | Mexico | 14000 | |
| 76 | Hospital General Valle de Hebron Servicio Medicina Interna. Edificio | Barcelona | Spain | 08035 | |
| 77 | Hospital Clinic y Provinical de Barcelona, Unitat de Malalties Autoimmunes | Barcelona | Spain | 08036 | |
| 78 | Hospital Universitario La Paz Servico de Medicina | Madrid | Spain | 28046 | |
| 79 | Department of Rheumatology, University Hospital of Lund | Lund | Sweden | S-22185 | |
| 80 | Department of Rheumatology, Karolinska Hospital | Stockholm | Sweden | S-17176 | |
| 81 | Rheumatology and Rehabilitation Unit | Leeds | United Kingdom | LS2 3EX | |
| 82 | Lupus Research Unit St. Thomas Hospital, The Rayne Institute | London | United Kingdom | SE1 7EH |
Sponsors and Collaborators
- La Jolla Pharmaceutical Company
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00035308
Other Study ID Numbers:
- LJP 394-90-09
First Posted:
May 3, 2002
Last Update Posted:
Sep 25, 2006
Last Verified:
Dec 1, 2002
Keywords provided by ,
,
Additional relevant MeSH terms: