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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00035308
Other study ID # LJP 394-90-09
Secondary ID
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
Est. primary completion date
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


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, 

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