Study of Abetimus Sodium in Lupus Patients With History of Renal Disease

INTERVENTION: Weekly intravenous administration of 300 or 900 mg abetimus sodium or placebo for 52 weeks in patients with a history of SLE renal disease CONDITION: Systemic Lupus Erythematosus PRIMARY OUTCOME: The primary objective of this trial is to determine whether abetimus sodium is more effective than place in delaying the time to renal flare in SLE patients with a history of SLE renal disease. The safety and efficacy of abetimus sodium in SLE patients will be evaluated at weekly doses of 300 and 900 mg over than intended 52‐week exposure period SECONDARY OUTCOME: The secondary objectives of the trial are to determine whether treatment with abetimus sodium is more effective than placebo in reducing proteinuria and in delaying time to all major SLE flares INCLUSION CRITERIA: Males or females between 12 and 70 years old, inclusive Female patients must be non‐pregnant and non‐lactating and have a negative urine pregnancy test result prior to enrollment in the study. Female patients of childbearing potential (including peri menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate of less than 1% per year, when used consistently and correctly, for example oral contraceptives, contraceptive patch, implants, injectables, some intrauterine contraceptive devices [IUDs], or sexual abstinence) during the entire duration of the study. Males enrolled in the trial must have no plans to father a child during the course of the trial and agree to use adequate birth control methods Diagnosis of SLE for purposes of this trial utilize the 1996 Revised Criteria for the Classification of SLE as defined by the American College of Rheumatology (ACR) where a