Clinical trial NCT00035308: 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
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: La Jolla Pharmaceutical Company
Sponsor class: INDUSTRY
First posted: 2002-05-03
Enrollment: 330
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Huntsville
country: United States
facility: Rheumatology Associates of North Alabama
state: Alabama
city: Montgomery
country: United States
facility: Montgomery Rheumatology Associates
state: Alabama
city: Paradise Valley
country: United States
facility: Arizona Arthritis & Rheumatology
state: Arizona
city: La Jolla
country: United States
facility: Allergy and Rheumatology Medical Clinic
state: California
city: Los Angeles
country: United States
facility: Davida-USC Dialysis Center
state: California
city: Los Angeles
country: United States
facility: Wallace Rheumatic Study Center
state: California
city: Los Angeles
country: United States
facility: Private Practice
state: California
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
city: Rancho Cucamonga
country: United States
facility: Boling Clinical Trials
state: California
city: Rancho Cucamonga
country: United States
facility: Investigative Clinical Research
state: California
city: San Mateo
country: United States
facility: Private Practice
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Research & Education Institute, Medicine/Rheumatology Division
state: California
city: Farmington
country: United States
facility: University of Connecticut Health Center, Division of Rheumatology
state: Connecticut
city: Hamden
country: United States
facility: Arthritis and Osteoporosis Center, PC
state: Connecticut
city: Ft. Lauderdale
country: United States
facility: CRIA Research
state: Florida
city: St. Petersburg
country: United States
facility: nTouch Research Corp.
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine, Renal Division
state: Georgia
city: Macon
country: United States
facility: Private Practice
state: Georgia
city: Boise
country: United States
facility: Intermountain Research Center
state: Idaho
city: Boise
country: United States
facility: Radiant Research-Boise
state: Idaho
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rheumatology Associates
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Evansville
country: United States
facility: Rheumatology Consultants
state: Indiana
city: Indianapolis
country: United States
facility: Rheumatology Associates, PC
state: Indiana
city: Louisville
country: United States
facility: University of Louisville, Dept of Medicine/Division of Rheumatology
state: Kentucky
city: New Orleans
country: United States
facility: LSU Health Sciences Center, Department of Rheumatology
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Greenbelt
country: United States
facility: SOMARC, Trials, LLC
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System, Internal Medicine-Rheumatology
state: Michigan
city: Detroit
country: United States
facility: Wayne State University, Rheumatology Division
state: Michigan
city: St. Louis
country: United States
facility: Saint Louis University Health Sciences Center
state: Missouri
city: St. Louis
country: United States
facility: Washington University, Renal Division
state: Missouri
city: Jersey City
country: United States
facility: HIS Clinical Trials
state: New Jersey
city: Brooklyn
country: United States
facility: SUNY-Downstate
state: New York
city: Flushing
country: United States
facility: Nephrology Associates, PC
state: New York
city: Manhasset
country: United States
facility: NSUH-Division of Rheumatology
state: New York
city: New York
country: United States
facility: Ambulatory Clinical Research Center, Hospital for Joint Diseases Orthopaedic Institute, NYU
state: New York
city: New York
country: United States
facility: Hospital for Joint Diseases, Department of Rheumatology
state: New York
city: New York
country: United States
facility: Hospital for Joint Diseases, NYU Medical Center
state: New York
city: New York
country: United States
facility: Mt. Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia-Presbyterian Medical Center
state: New York
city: Rochester
country: United States
facility: AAIR Research Center
state: New York
city: Winston Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cleveland
country: United States
facility: Metrohealth Medical Center, Division of Rheumatology
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma State University
state: Oklahoma
city: Tulsa
country: United States
facility: Healthcare Research Consultants
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University, Division of Rheumatology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh, Div. of Rheumatology and Clinical Immun.
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Rapid City
country: United States
facility: Dakota Regional Rheumatology
state: South Dakota
city: Jackson
country: United States
facility: Medical Specialty Clinic
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee, Memphis
state: Tennessee
city: Dallas
country: United States
facility: Presbyterian Hospital of Dallas, Arthritis Consultation Center
state: Texas
city: Dallas
country: United States
facility: Radiant Research - Dallas
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center, Department of Internal Medicine
state: Texas
city: San Antonio
country: United States
facility: San Antonio Kidney Disease Center, Research Center
state: Texas
city: Fairfax
country: United States
facility: Clinical Research and Consulting Center
state: Virginia
city: Richmond
country: United States
facility: MedSource, Inc.
state: Virginia
city: Spokane
country: United States
facility: Arthritis Northwest
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Vienna
country: Austria
facility: Division of Rheumatology, Department of Internal Medicine
city: Toronto
country: Canada
facility: Arthritis Center of Excellence, Toronto Western Hospital, University Health Network
state: Ontario
city: Montreal
country: Canada
facility: Hospital Maisonnueve-Rosemont
state: Quebec
city: Strasbourg Cedex
country: France
facility: Service De Rhumatologie Hopital de Hautepierre
city: Berlin
country: Germany
facility: Universitatklinikum Charite, Medizinische Universitatsklinik
city: Dusseldorf
country: Germany
facility: MNR-Klinik/heinrich-Heine-University Dusseldorf
city: Erlangen
country: Germany
facility: Department for Internal Medicine and Institute of Immunology and Rheumatology
city: Pisa
country: Italy
facility: U.O di Reumatologia, Dipartimento di Medicina Interna, Universita di Pisa
city: Mexico City
country: Mexico
facility: Insituto Nacional de Ciencias Medicas Y Nutricion Salvador Zubiran, Depto. de Immunology y Rheumatology
city: Barcelona
country: Spain
facility: Hospital General Valle de Hebron Servicio Medicina Interna. Edificio
city: Barcelona
country: Spain
facility: Hospital Clinic y Provinical de Barcelona, Unitat de Malalties Autoimmunes
city: Madrid
country: Spain
facility: Hospital Universitario La Paz Servico de Medicina
city: Lund
country: Sweden
facility: Department of Rheumatology, University Hospital of Lund
city: Stockholm
country: Sweden
facility: Department of Rheumatology, Karolinska Hospital
city: Leeds
country: United Kingdom
facility: Rheumatology and Rehabilitation Unit
city: London
country: United Kingdom
facility: Lupus Research Unit St. Thomas Hospital, The Rayne Institute
Study officials:
References:
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.