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

La Jolla Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Lupus Nephritis

Lupus Glomerulonephritis

Immunologic Diseases

Systemic Lupus Erythematosus

Autoimmune Diseases

Treatments

Drug: Abetimus sodium (LJP 394)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00035308

LJP 394-90-09

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

12 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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