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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
  Purpose

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.


Condition Intervention Phase
Immunologic Diseases
Autoimmune Diseases
Systemic Lupus Erythematosus
Lupus Nephritis
Lupus Glomerulonephritis
Drug: Abetimus sodium (LJP 394)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by La Jolla Pharmaceutical Company:

Estimated Enrollment: 330
Estimated Study Completion Date: December 2002
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.

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035308

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Rheumatology Associates of North Alabama
Huntsville, Alabama, United States, 35801
Montgomery Rheumatology Associates
Montgomery, Alabama, United States, 36111
United States, Arizona
Arizona Arthritis & Rheumatology
Paradise Valley, Arizona, United States, 85253
United States, California
Allergy and Rheumatology Medical Clinic
La Jolla, California, United States, 92037
UCLA School of Medicine
Los Angeles, California, United States, 90095
Private Practice
Los Angeles, California, United States, 90057
Davida-USC Dialysis Center
Los Angeles, California, United States, 90033
Wallace Rheumatic Study Center
Los Angeles, California, United States, 90048
Boling Clinical Trials
Rancho Cucamonga, California, United States, 91730
Investigative Clinical Research
Rancho Cucamonga, California, United States, 91730
Private Practice
San Mateo, California, United States, 94401
Harbor-UCLA Research & Education Institute, Medicine/Rheumatology Division
Torrance, California, United States, 90502
United States, Connecticut
University of Connecticut Health Center, Division of Rheumatology
Farmington, Connecticut, United States, 06030-1310
Arthritis and Osteoporosis Center, PC
Hamden, Connecticut, United States, 06518
United States, Florida
CRIA Research
Ft. Lauderdale, Florida, United States, 33334
nTouch Research Corp.
St. Petersburg, Florida, United States, 33707
United States, Georgia
Emory University School of Medicine, Renal Division
Atlanta, Georgia, United States, 30322
Private Practice
Macon, Georgia, United States, 31211
United States, Idaho
Intermountain Research Center
Boise, Idaho, United States, 83702
Radiant Research-Boise
Boise, Idaho, United States, 83704
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Northwestern University
Chicago, Illinois, United States, 60611
Rheumatology Associates
Chicago, Illinois, United States, 60612
United States, Indiana
Rheumatology Consultants
Evansville, Indiana, United States, 47714
Rheumatology Associates, PC
Indianapolis, Indiana, United States, 46260
United States, Kentucky
University of Louisville, Dept of Medicine/Division of Rheumatology
Louisville, Kentucky, United States, 40292
United States, Louisiana
LSU Health Sciences Center, Department of Rheumatology
New Orleans, Louisiana, United States, 70112-2822
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
SOMARC, Trials, LLC
Greenbelt, Maryland, United States, 20770
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Health System, Internal Medicine-Rheumatology
Ann Arbor, Michigan, United States, 48109-0358
Wayne State University, Rheumatology Division
Detroit, Michigan, United States, 48201
United States, Missouri
Washington University, Renal Division
St. Louis, Missouri, United States, 63110
Saint Louis University Health Sciences Center
St. Louis, Missouri, United States, 63104
United States, New Jersey
HIS Clinical Trials
Jersey City, New Jersey, United States, 07306
United States, New York
SUNY-Downstate
Brooklyn, New York, United States, 11203
Nephrology Associates, PC
Flushing, New York, United States, 11355
NSUH-Division of Rheumatology
Manhasset, New York, United States, 11030
Ambulatory Clinical Research Center, Hospital for Joint Diseases Orthopaedic Institute, NYU
New York, New York, United States, 10003
Columbia-Presbyterian Medical Center
New York, New York, United States, 10032
Hospital for Joint Diseases, Department of Rheumatology
New York, New York, United States, 10003
Hospital for Joint Diseases, NYU Medical Center
New York, New York, United States, 10003
Mt. Sinai Medical Center
New York, New York, United States, 10029
AAIR Research Center
Rochester, New York, United States, 14618
United States, North Carolina
Wake Forest University School of Medicine
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Metrohealth Medical Center, Division of Rheumatology
Cleveland, Ohio, United States, 44109
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
Healthcare Research Consultants
Tulsa, Oklahoma, United States, 74135
Oklahoma State University
Tulsa, Oklahoma, United States, 74114
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Thomas Jefferson University, Division of Rheumatology
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh, Div. of Rheumatology and Clinical Immun.
Pittsburgh, Pennsylvania, United States, 15261
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, South Dakota
Dakota Regional Rheumatology
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Medical Specialty Clinic
Jackson, Tennessee, United States, 38301
University of Tennessee, Memphis
Memphis, Tennessee, United States, 38163
United States, Texas
Radiant Research - Dallas
Dallas, Texas, United States, 75235
Presbyterian Hospital of Dallas, Arthritis Consultation Center
Dallas, Texas, United States, 75231-4496
Texas Tech University Health Sciences Center, Department of Internal Medicine
Lubbock, Texas, United States, 79430
San Antonio Kidney Disease Center, Research Center
San Antonio, Texas, United States, 78229
United States, Virginia
Clinical Research and Consulting Center
Fairfax, Virginia, United States, 22031
MedSource, Inc.
Richmond, Virginia, United States, 23229
United States, Washington
Arthritis Northwest
Spokane, Washington, United States, 99204
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Austria
Division of Rheumatology, Department of Internal Medicine
Vienna, Austria, A-1090
Canada, Ontario
Arthritis Center of Excellence, Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada, M5T-2S8
Canada, Quebec
Hospital Maisonnueve-Rosemont
Montreal, Quebec, Canada, H1T 4B3
France
Service De Rhumatologie Hopital de Hautepierre
Strasbourg Cedex, France, 67098
Germany
Universitatklinikum Charite, Medizinische Universitatsklinik
Berlin, Germany, 10117
MNR-Klinik/heinrich-Heine-University Dusseldorf
Dusseldorf, Germany, 40225
Department for Internal Medicine and Institute of Immunology and Rheumatology
Erlangen, Germany, D-91054
Italy
U.O di Reumatologia, Dipartimento di Medicina Interna, Universita di Pisa
Pisa, Italy, 56126
Mexico
Insituto Nacional de Ciencias Medicas Y Nutricion Salvador Zubiran, Depto. de Immunology y Rheumatology
Mexico City, Mexico, 14000
Spain
Hospital General Valle de Hebron Servicio Medicina Interna. Edificio
Barcelona, Spain, 08035
Hospital Clinic y Provinical de Barcelona, Unitat de Malalties Autoimmunes
Barcelona, Spain, 08036
Hospital Universitario La Paz Servico de Medicina
Madrid, Spain, 28046
Sweden
Department of Rheumatology, University Hospital of Lund
Lund, Sweden, S-22185
Department of Rheumatology, Karolinska Hospital
Stockholm, Sweden, S-17176
United Kingdom
Rheumatology and Rehabilitation Unit
Leeds, United Kingdom, LS2 3EX
Lupus Research Unit St. Thomas Hospital, The Rayne Institute
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
La Jolla Pharmaceutical Company
  More Information

No publications provided by La Jolla Pharmaceutical Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00035308     History of Changes
Other Study ID Numbers: LJP 394-90-09
Study First Received: May 2, 2002
Last Updated: September 22, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by La Jolla Pharmaceutical Company:
Immunologic Diseases
Autoimmune Diseases
Systemic Lupus Erythematosus
SLE
Lupus Nephritis
Lupus Glomerulonephritis

Additional relevant MeSH terms:
Autoimmune Diseases
Glomerulonephritis
Immune System Diseases
Lupus Erythematosus, Systemic
Lupus Nephritis
Nephritis
Connective Tissue Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014