Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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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Ages Eligible for Study:
12 Years to 70 Years (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosed with SLE
Historical evidence of SLE renal disease
Elevated levels of dsDNA antibodies
Weight of 40 kg or greater
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