Immunologic DiseasesPhase 3NCT00035308
Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease
A Phase 3 study testing Abetimus sodium (LJP 394) in people with Immunologic Diseases and Autoimmune Diseases, run by La Jolla Pharmaceutical Company at 82 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Immunologic Diseases, Autoimmune Diseases, Systemic Lupus Erythematosus
- What is being tested?
- Abetimus sodium (LJP 394)
- How many people
- 330 participants
- Where
- 82 sitesin 10 countries
- Study dates
- Start not givento Dec 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with SLE
- Historical evidence of SLE renal disease
- Elevated levels of dsDNA antibodies
- Weight of 40 kg or greater
Who cannot join
- 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
Trial locations and contacts
82 sites in 10 countries.
82 sites in 10 countries
United States66 sites
University of Michigan Health System, Internal Medicine-Rheumatology
Ann Arbor, Michigan, 48109-0358
Emory University School of Medicine, Renal Division
Atlanta, Georgia, 30322
Johns Hopkins University
Baltimore, Maryland, 21205
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Intermountain Research Center
Boise, Idaho, 83702
Radiant Research-Boise
Boise, Idaho, 83704
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
SUNY-Downstate
Brooklyn, New York, 11203
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
Rheumatology Associates
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
Metrohealth Medical Center, Division of Rheumatology
Cleveland, Ohio, 44109
Presbyterian Hospital of Dallas, Arthritis Consultation Center
Dallas, Texas, 75231-4496
Radiant Research - Dallas
Dallas, Texas, 75235
Wayne State University, Rheumatology Division
Detroit, Michigan, 48201
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Rheumatology Consultants
Evansville, Indiana, 47714
Clinical Research and Consulting Center
Fairfax, Virginia, 22031
University of Connecticut Health Center, Division of Rheumatology
Farmington, Connecticut, 06030-1310
Nephrology Associates, PC
Flushing, New York, 11355
CRIA Research
Fort Lauderdale, Florida, 33334
SOMARC, Trials, LLC
Greenbelt, Maryland, 20770
Arthritis and Osteoporosis Center, PC
Hamden, Connecticut, 06518
Rheumatology Associates of North Alabama
Huntsville, Alabama, 35801
Rheumatology Associates, PC
Indianapolis, Indiana, 46260
Medical Specialty Clinic
Jackson, Tennessee, 38301
HIS Clinical Trials
Jersey City, New Jersey, 07306
Allergy and Rheumatology Medical Clinic
La Jolla, California, 92037
Davida-USC Dialysis Center
Los Angeles, California, 90033
Wallace Rheumatic Study Center
Los Angeles, California, 90048
Private Practice
Los Angeles, California, 90057
UCLA School of Medicine
Los Angeles, California, 90095
University of Louisville, Dept of Medicine/Division of Rheumatology
Louisville, Kentucky, 40292
Texas Tech University Health Sciences Center, Department of Internal Medicine
Lubbock, Texas, 79430
Private Practice
Macon, Georgia, 31211
NSUH-Division of Rheumatology
Manhasset, New York, 11030
University of Tennessee, Memphis
Memphis, Tennessee, 38163
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Montgomery Rheumatology Associates
Montgomery, Alabama, 36111
LSU Health Sciences Center, Department of Rheumatology
New Orleans, Louisiana, 70112-2822
Ochsner Clinic
New Orleans, Louisiana, 70121
Ambulatory Clinical Research Center, Hospital for Joint Diseases Orthopaedic Institute, NYU
New York, New York, 10003
Hospital for Joint Diseases, Department of Rheumatology
New York, New York, 10003
Hospital for Joint Diseases, NYU Medical Center
New York, New York, 10003
Mt. Sinai Medical Center
New York, New York, 10029
Columbia-Presbyterian Medical Center
New York, New York, 10032
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
Arizona Arthritis & Rheumatology
Paradise Valley, Arizona, 85253
Thomas Jefferson University, Division of Rheumatology
Philadelphia, Pennsylvania, 19107
University of Pittsburgh, Div. of Rheumatology and Clinical Immun.
Pittsburgh, Pennsylvania, 15261
Boling Clinical Trials
Rancho Cucamonga, California, 91730
Investigative Clinical Research
Rancho Cucamonga, California, 91730
Dakota Regional Rheumatology
Rapid City, South Dakota, 57701
MedSource, Inc.
Richmond, Virginia, 23229
AAIR Research Center
Rochester, New York, 14618
San Antonio Kidney Disease Center, Research Center
San Antonio, Texas, 78229
Private Practice
San Mateo, California, 94401
Arthritis Northwest
Spokane, Washington, 99204
Saint Louis University Health Sciences Center
St Louis, Missouri, 63104
Washington University, Renal Division
St Louis, Missouri, 63110
nTouch Research Corp.
St. Petersburg, Florida, 33707
Harbor-UCLA Research & Education Institute, Medicine/Rheumatology Division
Torrance, California, 90502
Oklahoma State University
Tulsa, Oklahoma, 74114
Healthcare Research Consultants
Tulsa, Oklahoma, 74135
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
Germany3 sites
Universitatklinikum Charite, Medizinische Universitatsklinik
Berlin, 10117
MNR-Klinik/heinrich-Heine-University Dusseldorf
Düsseldorf, 40225
Department for Internal Medicine and Institute of Immunology and Rheumatology
Erlangen, D-91054
Spain3 sites
Hospital General Valle de Hebron Servicio Medicina Interna. Edificio
Barcelona, 08035
Hospital Clinic y Provinical de Barcelona, Unitat de Malalties Autoimmunes
Barcelona, 08036
Hospital Universitario La Paz Servico de Medicina
Madrid, 28046
Canada2 sites
Hospital Maisonnueve-Rosemont
Montreal, Quebec, H1T 4B3
Arthritis Center of Excellence, Toronto Western Hospital, University Health Network
Toronto, Ontario, M5T-2S8
Sweden2 sites
Department of Rheumatology, University Hospital of Lund
Lund, S-22185
Department of Rheumatology, Karolinska Hospital
Stockholm, S-17176
United Kingdom2 sites
Rheumatology and Rehabilitation Unit
Leeds, LS2 3EX
Lupus Research Unit St. Thomas Hospital, The Rayne Institute
London, SE1 7EH
Austria1 site
Division of Rheumatology, Department of Internal Medicine
Vienna, A-1090
Italy1 site
U.O di Reumatologia, Dipartimento di Medicina Interna, Universita di Pisa
Pisa, 56126
Mexico1 site
Insituto Nacional de Ciencias Medicas Y Nutricion Salvador Zubiran, Depto. de Immunology y Rheumatology
Mexico City, 14000
About this study
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
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.
Read the 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.
- Conditions
- Immunologic Diseases, Autoimmune Diseases, Systemic Lupus Erythematosus, Lupus Nephritis, Lupus Glomerulonephritis
- Being tested
- Abetimus sodium (LJP 394)
- Keywords
- Immunologic Diseases, Autoimmune Diseases, Systemic Lupus Erythematosus, SLE, Lupus Nephritis, Lupus Glomerulonephritis
- Medical subject headings
- Immune System Diseases, Autoimmune Diseases, Lupus Erythematosus, Systemic, Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abetimus sodium (LJP 394)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2002 (estimated)
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immunologic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 330 participants
Sponsor and investigators
- Lead sponsor
- La Jolla Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035308
- Sponsor's protocol ID
- LJP 394-90-09
- Status last verified
- Dec 2002
- First submitted
- 2 May 2002
- Last updated
- 25 Sep 2006
- Results posted
- No
Publications
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.
PubMed 18668592
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00035308
- Acronym / sponsor ID
- LJP 394-90-09
- Conditions
- Immunologic Diseases, Autoimmune Diseases, Systemic Lupus Erythematosus, Lupus Nephritis, Lupus Glomerulonephritis
- Keywords
- Immunologic Diseases, Autoimmune Diseases, Systemic Lupus Erythematosus, SLE, Lupus Nephritis, Lupus Glomerulonephritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants
- Lead sponsor
- La Jolla Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study completion
- Dec 2002
- First posted
- 3 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with SLE
- Historical evidence of SLE renal disease
- Elevated levels of dsDNA antibodies
- Weight of 40 kg or greater
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abetimus sodium (LJP 394) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2006.
- Derived from this study: PubMed 18668592Cardiel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
82 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abetimus sodium (LJP 394) in people with Immunologic Diseases and Autoimmune Diseases, run by La Jolla Pharmaceutical Company at 82 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in United States, Germany, Spain, Canada, Sweden and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00035308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2006.