Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease
Completed · Phase 3
Conditions studied: Immunologic Diseases, Autoimmune Diseases, Systemic Lupus Erythematosus, Lupus Nephritis, Lupus Glomerulonephritis
In brief
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.
Key facts
- Study ID
- NCT00035308
- Run by
- La Jolla Pharmaceutical Company
- People needed
- 330
- Expected to finish
- 2002-12-01
- Last updated by the study team
- 2006-09-25
Who can join
Age: 12 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with SLE
- Historical evidence of SLE renal disease
- Elevated levels of dsDNA antibodies
- Weight of 40 kg or greater
You may not qualify if…
- 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
Where it is running
- Rheumatology Associates of North Alabama — Huntsville, Alabama, United States
- Montgomery Rheumatology Associates — Montgomery, Alabama, United States
- Arizona Arthritis & Rheumatology — Paradise Valley, Arizona, United States
- Allergy and Rheumatology Medical Clinic — La Jolla, California, United States
- Davida-USC Dialysis Center — Los Angeles, California, United States
- Wallace Rheumatic Study Center — Los Angeles, California, United States
- Private Practice — Los Angeles, California, United States
- UCLA School of Medicine — Los Angeles, California, United States
- Boling Clinical Trials — Rancho Cucamonga, California, United States
- Investigative Clinical Research — Rancho Cucamonga, California, United States
- Private Practice — San Mateo, California, United States
- Harbor-UCLA Research & Education Institute, Medicine/Rheumatology Division — Torrance, California, United States
- University of Connecticut Health Center, Division of Rheumatology — Farmington, Connecticut, United States
- Arthritis and Osteoporosis Center, PC — Hamden, Connecticut, United States
- CRIA Research — Fort Lauderdale, Florida, United States
- nTouch Research Corp. — St. Petersburg, Florida, United States
- Emory University School of Medicine, Renal Division — Atlanta, Georgia, United States
- Private Practice — Macon, Georgia, United States
- Intermountain Research Center — Boise, Idaho, United States
- Radiant Research-Boise — Boise, Idaho, United States
- Northwestern University — Chicago, Illinois, United States
- Rheumatology Associates — Chicago, Illinois, United States
- University of Chicago — Chicago, Illinois, United States
- Rheumatology Consultants — Evansville, Indiana, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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