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

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Safety and Efficacy Trial of LJP 394 in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00035308

Enrollment

330

Registered

2002-05-03

Start date

Unknown

Completion date

2002-12-31

Last updated

2006-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunologic Diseases, Autoimmune Diseases, Systemic Lupus Erythematosus, Lupus Nephritis, Lupus Glomerulonephritis

Keywords

Immunologic Diseases, Autoimmune Diseases, Systemic Lupus Erythematosus, SLE, Lupus Nephritis, Lupus Glomerulonephritis

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.

Interventions

DRUGAbetimus sodium (LJP 394)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

12 Years to 70 Years

Healthy volunteers

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

Countries

Austria, Canada, France, Germany, Italy, Mexico, Spain, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026