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

May 2, 2002
September 22, 2006
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Complete list of historical versions of study NCT00035308 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Immunologic Diseases
  • Autoimmune Diseases
  • Systemic Lupus Erythematosus
  • Lupus Nephritis
  • Lupus Glomerulonephritis
Drug: Abetimus sodium (LJP 394)
Not Provided
Cardiel MH, Tumlin JA, Furie RA, Wallace DJ, Joh T, Linnik MD; LJP 394-90-09 Investigator Consortium. Abetimus sodium for renal flare in systemic lupus erythematosus: results of a randomized, controlled phase III trial. Arthritis Rheum. 2008 Aug;58(8):2470-80.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
330
December 2002
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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
Both
12 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Germany,   Sweden,   Austria,   Spain,   Mexico,   United Kingdom,   France,   Italy
 
NCT00035308
LJP 394-90-09
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La Jolla Pharmaceutical Company
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La Jolla Pharmaceutical Company
December 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP