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

Tracking Information
First Received Date ^ICMJE	May 2, 2002
Last Updated Date	September 22, 2006
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00035308 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease
Official Title ^ICMJE	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
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Immunologic Diseases Autoimmune Diseases Systemic Lupus Erythematosus Lupus Nephritis Lupus Glomerulonephritis
Intervention ^ICMJE	Drug: Abetimus sodium (LJP 394)
Study Arm (s)	Not Provided
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	330
Completion Date	December 2002
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	12 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Austria, Canada, France, Germany, Italy, Mexico, Spain, Sweden, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00035308
Other Study ID Numbers ^ICMJE	LJP 394-90-09
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	La Jolla Pharmaceutical Company
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	La Jolla Pharmaceutical Company
Verification Date	December 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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