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

This study has been completed.
Sponsor:
Information provided by:
La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier:
NCT00035308
First received: May 2, 2002
Last updated: September 22, 2006
Last verified: December 2002
History of Changes
  Purpose

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 Intervention Phase
Immunologic Diseases
Autoimmune Diseases
Systemic Lupus Erythematosus
Lupus Nephritis
Lupus Glomerulonephritis
 Drug: Abetimus sodium (LJP 394)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by La Jolla Pharmaceutical Company:

Estimated Enrollment: 330
Estimated Study Completion Date: December 2002
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.

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035308

  Show 82 Study Locations
Sponsors and Collaborators
La Jolla Pharmaceutical Company
  More Information

No publications provided by La Jolla Pharmaceutical Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00035308     History of Changes
Other Study ID Numbers: LJP 394-90-09
Study First Received: May 2, 2002
Last Updated: September 22, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by La Jolla Pharmaceutical Company:
Immunologic Diseases
Autoimmune Diseases
Systemic Lupus Erythematosus
 SLE
Lupus Nephritis
Lupus Glomerulonephritis

Additional relevant MeSH terms:
Autoimmune Diseases
Glomerulonephritis
Immune System Diseases
Lupus Erythematosus, Systemic
Lupus Nephritis
 Nephritis
Kidney Diseases
Urologic Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on June 13, 2013