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Clinical Trials
NCT00035308

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

Last Updated: 2006-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2002-12-31

Brief Summary

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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

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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.

Conditions

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Immunologic Diseases Autoimmune Diseases Systemic Lupus Erythematosus Lupus Nephritis Lupus Glomerulonephritis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Abetimus sodium (LJP 394)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Rheumatology Associates of North Alabama

Huntsville, Alabama, United States

Site Status

Montgomery Rheumatology Associates

Montgomery, Alabama, United States

Site Status

Arizona Arthritis & Rheumatology

Paradise Valley, Arizona, United States

Site Status

Allergy and Rheumatology Medical Clinic

La Jolla, California, United States

Site Status

Davida-USC Dialysis Center

Los Angeles, California, United States

Site Status

Wallace Rheumatic Study Center

Los Angeles, California, United States

Site Status

Private Practice

Los Angeles, California, United States

Site Status

UCLA School of Medicine

Los Angeles, California, United States

Site Status

Boling Clinical Trials

Rancho Cucamonga, California, United States

Site Status

Investigative Clinical Research

Rancho Cucamonga, California, United States

Site Status

Private Practice

San Mateo, California, United States

Site Status

Harbor-UCLA Research & Education Institute, Medicine/Rheumatology Division

Torrance, California, United States

Site Status

University of Connecticut Health Center, Division of Rheumatology

Farmington, Connecticut, United States

Site Status

Arthritis and Osteoporosis Center, PC

Hamden, Connecticut, United States

Site Status

CRIA Research

Fort Lauderdale, Florida, United States

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nTouch Research Corp.

St. Petersburg, Florida, United States

Site Status

Emory University School of Medicine, Renal Division

Atlanta, Georgia, United States

Site Status

Private Practice

Macon, Georgia, United States

Site Status

Intermountain Research Center

Boise, Idaho, United States

Site Status

Radiant Research-Boise

Boise, Idaho, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Rheumatology Associates

Chicago, Illinois, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Rheumatology Consultants

Evansville, Indiana, United States

Site Status

Rheumatology Associates, PC

Indianapolis, Indiana, United States

Site Status

University of Louisville, Dept of Medicine/Division of Rheumatology

Louisville, Kentucky, United States

Site Status

LSU Health Sciences Center, Department of Rheumatology

New Orleans, Louisiana, United States

Site Status

Ochsner Clinic

New Orleans, Louisiana, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

SOMARC, Trials, LLC

Greenbelt, Maryland, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

University of Michigan Health System, Internal Medicine-Rheumatology

Ann Arbor, Michigan, United States

Site Status

Wayne State University, Rheumatology Division

Detroit, Michigan, United States

Site Status

Saint Louis University Health Sciences Center

St Louis, Missouri, United States

Site Status

Washington University, Renal Division

St Louis, Missouri, United States

Site Status

HIS Clinical Trials

Jersey City, New Jersey, United States

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SUNY-Downstate

Brooklyn, New York, United States

Site Status

Nephrology Associates, PC

Flushing, New York, United States

Site Status