Study of LJP 394 in Lupus Patients With History of Renal Disease

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to determine whether abetimus sodium is more effective than placebo in delaying time to renal flare in SLE patients with a history of renal disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: La Jolla Pharmaceutical Company
• Treatments: Abetimus

Criteria

Inclusion Criteria:

• Diagnosis of Systemic Lupus Erythematosus (SLE)

• Active SLE renal disease within past 4 years.

• Males or females between 12 and 70 years old.

• Females must be non-pregnant and non-lactating. Females and males must use adequate birth control methods during course of study.

• Ability to have weekly intravenous (IV) administration of study treatment.

Exclusion Criteria:

• Active SLE renal disease within past 3 months prior to entering study.

• Use of the following therapies within 3 months prior to entering the study: alkylating agents, e.g., cyclophosphamide, TNF inhibitors, cyclosporine.

• Use of 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.

• Use of rituximab within 6 months prior to entering study.

• Current abuse of drugs or alcohol.