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

September 22, 2006 updated by: La Jolla Pharmaceutical Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

330

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

La Jolla Pharmaceutical Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion

December 1, 2002

Study Registration Dates

First Submitted

May 2, 2002

First Submitted That Met QC Criteria

May 2, 2002

First Posted (Estimate)

May 3, 2002

Study Record Updates

Last Update Posted (Estimate)

September 25, 2006

Last Update Submitted That Met QC Criteria

September 22, 2006

Last Verified

December 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LJP 394-90-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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