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

Systemic Lupus Erythematosus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035308
• Other study ID #: LJP 394-90-09
• Status: Completed
• Phase: Phase 3
• First received: May 2, 2002
• Last updated: September 22, 2006
• Est. completion date: December 2002

Study information

• Verified date: December 2002
• Source: La Jolla Pharmaceutical Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autoimmune Diseases
• Glomerulonephritis
• Immune System Diseases
• Immunologic Diseases
• Lupus Erythematosus, Systemic
• Lupus Glomerulonephritis
• Lupus Nephritis
• Nephritis
• Systemic Lupus Erythematosus

Intervention

Drug:
• Abetimus sodium (LJP 394)

Locations

Country	Name	City	State
Austria	Division of Rheumatology, Department of Internal Medicine	Vienna
Canada	Hospital Maisonnueve-Rosemont	Montreal	Quebec
Canada	Arthritis Center of Excellence, Toronto Western Hospital, University Health Network	Toronto	Ontario
France	Service De Rhumatologie Hopital de Hautepierre	Strasbourg Cedex
Germany	Universitatklinikum Charite, Medizinische Universitatsklinik	Berlin
Germany	MNR-Klinik/heinrich-Heine-University Dusseldorf	Dusseldorf
Germany	Department for Internal Medicine and Institute of Immunology and Rheumatology	Erlangen
Italy	U.O di Reumatologia, Dipartimento di Medicina Interna, Universita di Pisa	Pisa
Mexico	Insituto Nacional de Ciencias Medicas Y Nutricion Salvador Zubiran, Depto. de Immunology y Rheumatology	Mexico City
Spain	Hospital Clinic y Provinical de Barcelona, Unitat de Malalties Autoimmunes	Barcelona
Spain	Hospital General Valle de Hebron Servicio Medicina Interna. Edificio	Barcelona
Spain	Hospital Universitario La Paz Servico de Medicina	Madrid
Sweden	Department of Rheumatology, University Hospital of Lund	Lund
Sweden	Department of Rheumatology, Karolinska Hospital	Stockholm
United Kingdom	Rheumatology and Rehabilitation Unit	Leeds
United Kingdom	Lupus Research Unit St. Thomas Hospital, The Rayne Institute	London
United States	University of Michigan Health System, Internal Medicine-Rheumatology	Ann Arbor	Michigan
United States	Emory University School of Medicine, Renal Division	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Intermountain Research Center	Boise	Idaho
United States	Radiant Research-Boise	Boise	Idaho
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	SUNY-Downstate	Brooklyn	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	Rheumatology Associates	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Metrohealth Medical Center, Division of Rheumatology	Cleveland	Ohio
United States	Presbyterian Hospital of Dallas, Arthritis Consultation Center	Dallas	Texas
United States	Radiant Research - Dallas	Dallas	Texas
United States	Wayne State University, Rheumatology Division	Detroit	Michigan
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Rheumatology Consultants	Evansville	Indiana
United States	Clinical Research and Consulting Center	Fairfax	Virginia
United States	University of Connecticut Health Center, Division of Rheumatology	Farmington	Connecticut
United States	Nephrology Associates, PC	Flushing	New York
United States	CRIA Research	Ft. Lauderdale	Florida
United States	SOMARC, Trials, LLC	Greenbelt	Maryland
United States	Arthritis and Osteoporosis Center, PC	Hamden	Connecticut
United States	Rheumatology Associates of North Alabama	Huntsville	Alabama
United States	Rheumatology Associates, PC	Indianapolis	Indiana
United States	Medical Specialty Clinic	Jackson	Tennessee
United States	HIS Clinical Trials	Jersey City	New Jersey
United States	Allergy and Rheumatology Medical Clinic	La Jolla	California
United States	Davida-USC Dialysis Center	Los Angeles	California
United States	Private Practice	Los Angeles	California
United States	UCLA School of Medicine	Los Angeles	California
United States	Wallace Rheumatic Study Center	Los Angeles	California
United States	University of Louisville, Dept of Medicine/Division of Rheumatology	Louisville	Kentucky
United States	Texas Tech University Health Sciences Center, Department of Internal Medicine	Lubbock	Texas
United States	Private Practice	Macon	Georgia
United States	NSUH-Division of Rheumatology	Manhasset	New York
United States	University of Tennessee, Memphis	Memphis	Tennessee
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Montgomery Rheumatology Associates	Montgomery	Alabama
United States	LSU Health Sciences Center, Department of Rheumatology	New Orleans	Louisiana
United States	Ochsner Clinic	New Orleans	Louisiana
United States	Ambulatory Clinical Research Center, Hospital for Joint Diseases Orthopaedic Institute, NYU	New York	New York
United States	Columbia-Presbyterian Medical Center	New York	New York
United States	Hospital for Joint Diseases, Department of Rheumatology	New York	New York
United States	Hospital for Joint Diseases, NYU Medical Center	New York	New York
United States	Mt. Sinai Medical Center	New York	New York
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma
United States	Arizona Arthritis & Rheumatology	Paradise Valley	Arizona
United States	Thomas Jefferson University, Division of Rheumatology	Philadelphia	Pennsylvania
United States	University of Pittsburgh, Div. of Rheumatology and Clinical Immun.	Pittsburgh	Pennsylvania
United States	Boling Clinical Trials	Rancho Cucamonga	California
United States	Investigative Clinical Research	Rancho Cucamonga	California
United States	Dakota Regional Rheumatology	Rapid City	South Dakota
United States	MedSource, Inc.	Richmond	Virginia
United States	AAIR Research Center	Rochester	New York
United States	San Antonio Kidney Disease Center, Research Center	San Antonio	Texas
United States	Private Practice	San Mateo	California
United States	Arthritis Northwest	Spokane	Washington
United States	Saint Louis University Health Sciences Center	St. Louis	Missouri
United States	Washington University, Renal Division	St. Louis	Missouri
United States	nTouch Research Corp.	St. Petersburg	Florida
United States	Harbor-UCLA Research & Education Institute, Medicine/Rheumatology Division	Torrance	California
United States	Healthcare Research Consultants	Tulsa	Oklahoma
United States	Oklahoma State University	Tulsa	Oklahoma
United States	Wake Forest University School of Medicine	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
La Jolla Pharmaceutical Company

Countries where clinical trial is conducted

United States,  Austria,  Canada,  France,  Germany,  Italy,  Mexico,  Spain,  Sweden,  United Kingdom,