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

Primary Purpose

Immunologic Diseases, Autoimmune Diseases, Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Abetimus sodium (LJP 394)
Sponsored by
La Jolla Pharmaceutical Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immunologic Diseases focused on measuring Immunologic Diseases, Autoimmune Diseases, Systemic Lupus Erythematosus, SLE, Lupus Nephritis, Lupus Glomerulonephritis

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Rheumatology Associates of North Alabama
  • Montgomery Rheumatology Associates
  • Arizona Arthritis & Rheumatology
  • Allergy and Rheumatology Medical Clinic
  • Davida-USC Dialysis Center
  • Wallace Rheumatic Study Center
  • Private Practice
  • UCLA School of Medicine
  • Boling Clinical Trials
  • Investigative Clinical Research
  • Private Practice
  • Harbor-UCLA Research & Education Institute, Medicine/Rheumatology Division
  • University of Connecticut Health Center, Division of Rheumatology
  • Arthritis and Osteoporosis Center, PC
  • CRIA Research
  • nTouch Research Corp.
  • Emory University School of Medicine, Renal Division
  • Private Practice
  • Intermountain Research Center
  • Radiant Research-Boise
  • Northwestern University
  • Rheumatology Associates
  • University of Chicago
  • Rheumatology Consultants
  • Rheumatology Associates, PC
  • University of Louisville, Dept of Medicine/Division of Rheumatology
  • LSU Health Sciences Center, Department of Rheumatology
  • Ochsner Clinic
  • Johns Hopkins University
  • SOMARC, Trials, LLC
  • Beth Israel Deaconess Medical Center
  • University of Michigan Health System, Internal Medicine-Rheumatology
  • Wayne State University, Rheumatology Division
  • Saint Louis University Health Sciences Center
  • Washington University, Renal Division
  • HIS Clinical Trials
  • SUNY-Downstate
  • Nephrology Associates, PC
  • NSUH-Division of Rheumatology
  • Ambulatory Clinical Research Center, Hospital for Joint Diseases Orthopaedic Institute, NYU
  • Hospital for Joint Diseases, Department of Rheumatology
  • Hospital for Joint Diseases, NYU Medical Center
  • Mt. Sinai Medical Center
  • Columbia-Presbyterian Medical Center
  • AAIR Research Center
  • Wake Forest University School of Medicine
  • Metrohealth Medical Center, Division of Rheumatology
  • Oklahoma Medical Research Foundation
  • Oklahoma State University
  • Healthcare Research Consultants
  • Altoona Center for Clinical Research
  • Thomas Jefferson University, Division of Rheumatology
  • University of Pittsburgh, Div. of Rheumatology and Clinical Immun.
  • Medical University of South Carolina
  • Dakota Regional Rheumatology
  • Medical Specialty Clinic
  • University of Tennessee, Memphis
  • Presbyterian Hospital of Dallas, Arthritis Consultation Center
  • Radiant Research - Dallas
  • Texas Tech University Health Sciences Center, Department of Internal Medicine
  • San Antonio Kidney Disease Center, Research Center
  • Clinical Research and Consulting Center
  • MedSource, Inc.
  • Arthritis Northwest
  • Medical College of Wisconsin
  • Division of Rheumatology, Department of Internal Medicine
  • Arthritis Center of Excellence, Toronto Western Hospital, University Health Network
  • Hospital Maisonnueve-Rosemont
  • Service De Rhumatologie Hopital de Hautepierre
  • Universitatklinikum Charite, Medizinische Universitatsklinik
  • MNR-Klinik/heinrich-Heine-University Dusseldorf
  • Department for Internal Medicine and Institute of Immunology and Rheumatology
  • U.O di Reumatologia, Dipartimento di Medicina Interna, Universita di Pisa
  • Insituto Nacional de Ciencias Medicas Y Nutricion Salvador Zubiran, Depto. de Immunology y Rheumatology
  • Hospital General Valle de Hebron Servicio Medicina Interna. Edificio
  • Hospital Clinic y Provinical de Barcelona, Unitat de Malalties Autoimmunes
  • Hospital Universitario La Paz Servico de Medicina
  • Department of Rheumatology, University Hospital of Lund
  • Department of Rheumatology, Karolinska Hospital
  • Rheumatology and Rehabilitation Unit
  • Lupus Research Unit St. Thomas Hospital, The Rayne Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 2, 2002
Last Updated
September 22, 2006
Sponsor
La Jolla Pharmaceutical Company
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1. Study Identification

Unique Protocol Identification Number
NCT00035308
Brief Title
Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2002
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
La Jolla Pharmaceutical Company

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunologic Diseases, Autoimmune Diseases, Systemic Lupus Erythematosus, Lupus Nephritis, Lupus Glomerulonephritis
Keywords
Immunologic Diseases, Autoimmune Diseases, Systemic Lupus Erythematosus, SLE, Lupus Nephritis, Lupus Glomerulonephritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
330 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Abetimus sodium (LJP 394)

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
18668592
Citation
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.
Results Reference
derived

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

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