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Sponsored by: |
La Jolla Pharmaceutical Company |
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Information provided by: | La Jolla Pharmaceutical Company |
ClinicalTrials.gov Identifier: | NCT00035308 |
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.
Ages Eligible for Study: | 12 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Study ID Numbers: | LJP 394-90-09 |
Study First Received: | May 2, 2002 |
Last Updated: | September 22, 2006 |
ClinicalTrials.gov Identifier: | NCT00035308 |
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 |
Lupus Nephritis Nephritis Connective Tissue Diseases Kidney Diseases |
Immune System Diseases |