Expired Study
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Clinical Trial 3816

Houston, TX 77070

Study Summary:

A Randomized, double-blind, placebo-controlled, three-arm, parallel-group, multicenter, multinational safety and efficacy trial of 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) patients with a history of renal disease.

Qualified Participants Must:

• Have a diagnosis of Systemic Lupus Erythematosus (SLE)
• Have active SLE renal disease within past 4 years
• Be 12 to 70 years of age
• Be non-pregnant and non-lactating
• Use adequate birth control methods during course of study
• Be able to have weekly intravenous (IV) administration of study treatment
• Not have active SLE renal disease within past 3 months prior to entering study
• Not use any of the following therapies within 3 months prior to entering the study: alkylating agents, e.g., cyclophosphamide, TNF inhibitors, cyclosporine
• Not use mycophenolate mofetil that exceeds 1000 mg/day, azathioprine that exceeds 100 mg/day, methotrexate that exceeds 10 mg/week, leflunomide that exceeds 10 mg/day within 2 months prior to entering study
• Not use rituximab within 6 months prior to entering study
• Not have any current abuse of drugs or alcohol

Qualified Participants May Receive:

Study medication and study treatment at no cost. Financial reimbursement will also be given for time and travel.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.