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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00035308
Recruitment Status : Completed
First Posted : May 3, 2002
Last Update Posted : September 25, 2006
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Immunologic Diseases Autoimmune Diseases Systemic Lupus Erythematosus Lupus Nephritis Lupus Glomerulonephritis Drug: Abetimus sodium (LJP 394) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Completion Date : December 2002

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00035308

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Sponsors and Collaborators
La Jolla Pharmaceutical Company
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00035308    
Other Study ID Numbers: LJP 394-90-09
First Posted: May 3, 2002    Key Record Dates
Last Update Posted: September 25, 2006
Last Verified: December 2002
Keywords provided by La Jolla Pharmaceutical Company:
Immunologic Diseases
Autoimmune Diseases
Systemic Lupus Erythematosus
Lupus Nephritis
Lupus Glomerulonephritis
Additional relevant MeSH terms:
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Lupus Nephritis
Lupus Erythematosus, Systemic
Autoimmune Diseases
Immune System Diseases
Connective Tissue Diseases
Kidney Diseases
Urologic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs