Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease
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
1 other identifier
interventional
330
10 countries
82
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2002
CompletedFirst Posted
Study publicly available on registry
May 3, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2002
CompletedSeptember 25, 2006
December 1, 2002
May 2, 2002
September 22, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with SLE
- Historical evidence of SLE renal disease
- Elevated levels of dsDNA antibodies
- Weight of 40 kg or greater
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (82)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Rheumatology Associates of North Alabama
Huntsville, Alabama, 35801, United States
Montgomery Rheumatology Associates
Montgomery, Alabama, 36111, United States
Arizona Arthritis & Rheumatology
Paradise Valley, Arizona, 85253, United States
Allergy and Rheumatology Medical Clinic
La Jolla, California, 92037, United States
Davida-USC Dialysis Center
Los Angeles, California, 90033, United States
Wallace Rheumatic Study Center
Los Angeles, California, 90048, United States
Private Practice
Los Angeles, California, 90057, United States
UCLA School of Medicine
Los Angeles, California, 90095, United States
Boling Clinical Trials
Rancho Cucamonga, California, 91730, United States
Investigative Clinical Research
Rancho Cucamonga, California, 91730, United States
Private Practice
San Mateo, California, 94401, United States
Harbor-UCLA Research & Education Institute, Medicine/Rheumatology Division
Torrance, California, 90502, United States
University of Connecticut Health Center, Division of Rheumatology
Farmington, Connecticut, 06030-1310, United States
Arthritis and Osteoporosis Center, PC
Hamden, Connecticut, 06518, United States
CRIA Research
Fort Lauderdale, Florida, 33334, United States
nTouch Research Corp.
St. Petersburg, Florida, 33707, United States
Emory University School of Medicine, Renal Division
Atlanta, Georgia, 30322, United States
Private Practice
Macon, Georgia, 31211, United States
Intermountain Research Center
Boise, Idaho, 83702, United States
Radiant Research-Boise
Boise, Idaho, 83704, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rheumatology Associates
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
Rheumatology Consultants
Evansville, Indiana, 47714, United States
Rheumatology Associates, PC
Indianapolis, Indiana, 46260, United States
University of Louisville, Dept of Medicine/Division of Rheumatology
Louisville, Kentucky, 40292, United States
LSU Health Sciences Center, Department of Rheumatology
New Orleans, Louisiana, 70112-2822, United States
Ochsner Clinic
New Orleans, Louisiana, 70121, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
SOMARC, Trials, LLC
Greenbelt, Maryland, 20770, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan Health System, Internal Medicine-Rheumatology
Ann Arbor, Michigan, 48109-0358, United States
Wayne State University, Rheumatology Division
Detroit, Michigan, 48201, United States
Saint Louis University Health Sciences Center
St Louis, Missouri, 63104, United States
Washington University, Renal Division
St Louis, Missouri, 63110, United States
HIS Clinical Trials
Jersey City, New Jersey, 07306, United States
SUNY-Downstate
Brooklyn, New York, 11203, United States
Nephrology Associates, PC
Flushing, New York, 11355, United States
NSUH-Division of Rheumatology
Manhasset, New York, 11030, United States
Ambulatory Clinical Research Center, Hospital for Joint Diseases Orthopaedic Institute, NYU
New York, New York, 10003, United States
Hospital for Joint Diseases, Department of Rheumatology
New York, New York, 10003, United States
Hospital for Joint Diseases, NYU Medical Center
New York, New York, 10003, United States
Mt. Sinai Medical Center
New York, New York, 10029, United States
Columbia-Presbyterian Medical Center
New York, New York, 10032, United States
AAIR Research Center
Rochester, New York, 14618, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
Metrohealth Medical Center, Division of Rheumatology
Cleveland, Ohio, 44109, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104, United States
Oklahoma State University
Tulsa, Oklahoma, 74114, United States
Healthcare Research Consultants
Tulsa, Oklahoma, 74135, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Thomas Jefferson University, Division of Rheumatology
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh, Div. of Rheumatology and Clinical Immun.
Pittsburgh, Pennsylvania, 15261, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Dakota Regional Rheumatology
Rapid City, South Dakota, 57701, United States
Medical Specialty Clinic
Jackson, Tennessee, 38301, United States
University of Tennessee, Memphis
Memphis, Tennessee, 38163, United States
Presbyterian Hospital of Dallas, Arthritis Consultation Center
Dallas, Texas, 75231-4496, United States
Radiant Research - Dallas
Dallas, Texas, 75235, United States
Texas Tech University Health Sciences Center, Department of Internal Medicine
Lubbock, Texas, 79430, United States
San Antonio Kidney Disease Center, Research Center
San Antonio, Texas, 78229, United States
Clinical Research and Consulting Center
Fairfax, Virginia, 22031, United States
MedSource, Inc.
Richmond, Virginia, 23229, United States
Arthritis Northwest
Spokane, Washington, 99204, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Division of Rheumatology, Department of Internal Medicine
Vienna, A-1090, Austria
Arthritis Center of Excellence, Toronto Western Hospital, University Health Network
Toronto, Ontario, M5T-2S8, Canada
Hospital Maisonnueve-Rosemont
Montreal, Quebec, H1T 4B3, Canada
Service De Rhumatologie Hopital de Hautepierre
Strasbourg, 67098, France
Universitatklinikum Charite, Medizinische Universitatsklinik
Berlin, 10117, Germany
MNR-Klinik/heinrich-Heine-University Dusseldorf
Düsseldorf, 40225, Germany
Department for Internal Medicine and Institute of Immunology and Rheumatology
Erlangen, D-91054, Germany
U.O di Reumatologia, Dipartimento di Medicina Interna, Universita di Pisa
Pisa, 56126, Italy
Insituto Nacional de Ciencias Medicas Y Nutricion Salvador Zubiran, Depto. de Immunology y Rheumatology
Mexico City, 14000, Mexico
Hospital General Valle de Hebron Servicio Medicina Interna. Edificio
Barcelona, 08035, Spain
Hospital Clinic y Provinical de Barcelona, Unitat de Malalties Autoimmunes
Barcelona, 08036, Spain
Hospital Universitario La Paz Servico de Medicina
Madrid, 28046, Spain
Department of Rheumatology, University Hospital of Lund
Lund, S-22185, Sweden
Department of Rheumatology, Karolinska Hospital
Stockholm, S-17176, Sweden
Rheumatology and Rehabilitation Unit
Leeds, LS2 3EX, United Kingdom
Lupus Research Unit St. Thomas Hospital, The Rayne Institute
London, SE1 7EH, United Kingdom
Related Publications (1)
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. doi: 10.1002/art.23673.
PMID: 18668592DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 2, 2002
First Posted
May 3, 2002
Study Completion
December 1, 2002
Last Updated
September 25, 2006
Record last verified: 2002-12