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

Phase 3

Completed

• Conditions: Immunologic Diseases; Autoimmune Diseases; Systemic Lupus Erythematosus; Lupus Nephritis; Lupus Glomerulonephritis

• Registration Number: NCT00035308
• Lead Sponsor: La Jolla Pharmaceutical Company

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2002-05-02
• Study First Submitted QC: 2002-05-02
• Study First Posted: 2002-05-03
• Status Verified: 2002-12
• Study Completion: 2002-12
• Last Update Submitted: 2006-09-22
• Last Update Posted: 2006-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (80)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Rheumatology Associates of North Alabama; 🇺🇸 Huntsville, Alabama, United States

Montgomery Rheumatology Associates; 🇺🇸 Montgomery, Alabama, United States

Arizona Arthritis & Rheumatology; 🇺🇸 Paradise Valley, Arizona, United States

Allergy and Rheumatology Medical Clinic; 🇺🇸 La Jolla, California, United States

Davida-USC Dialysis Center; 🇺🇸 Los Angeles, California, United States

Wallace Rheumatic Study Center; 🇺🇸 Los Angeles, California, United States

Private Practice; 🇺🇸 Macon, Georgia, United States

UCLA School of Medicine; 🇺🇸 Los Angeles, California, United States

Boling Clinical Trials; 🇺🇸 Rancho Cucamonga, California, United States

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