Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

Criteria

Inclusion Criteria

• Diagnosed with SLE

• Historical evidence of SLE renal disease

• Elevated levels of dsDNA antibodies

• Weight of 40 kg or greater

Exclusion Criteria

• 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

• Malignant disease or immunodeficiency syndrome

• Acute or chronic infections

• History of serious heart disease