Study of LJP 394 in Lupus Patients With History of Renal Disease - Full Text View

Sponsored by:	La Jolla Pharmaceutical Company
Information provided by:	La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier:	NCT00089804

Purpose

The primary purpose of this study is to determine whether abetimus sodium is more effective than placebo in delaying time to renal flare in SLE patients with a history of renal disease.

Condition	Intervention	Phase
Lupus Erythematosus, Systemic Lupus Nephritis	Drug: abetimus sodium (LJP 394) and/or placebo solution Drug: abetimus sodium (LJP 394) Drug: Phosphate-buffered saline	Phase III

MedlinePlus related topics: Lupus

Drug Information available for: Abetimus Abetimus sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease

Further study details as provided by La Jolla Pharmaceutical Company:

Primary Outcome Measures:

To determine whether abetimus sodium is more effective than placebo in delaying the time to renal flare in SLE patients with a history of SLE renal disease. Weekly administration with a 52-week treatment duration. [ Time Frame: Time to event (12 months fixed treatment duration) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine whether treatment with abetimus sodium is more effective than placebo in delaying the time to Major SLE flare; and to determine whether treatment with abetimus sodium (LJP 394) is more effective than placebo in reducing proteinuria. [ Time Frame: 12 month fixed treatment duration ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	730
Study Start Date:	October 2004
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 300 mg (three 2 mL vials of abetimus sodium plus six 2 mL vials of normal saline) administered i.v (in the vien) weekly	Drug: abetimus sodium (LJP 394) and/or placebo solution 300 mg (50 mg/mL)abetimus sodium (three 2 mL vials of of abetimus sodium plus six 2 mL vials of normal saline) administered i.v. (in the vien) weekly for 52 weeks
2: Active Comparator 900 mg (nine 2 mL vials of abetimus sodium) administered i.v. (in the vein) weekly	Drug: abetimus sodium (LJP 394) 900 mg (50 mg/mL) abetimus sodium (nine 2 mL vials) administered i.v. (in the vien) weekly for 52 weeks.
3: Placebo Comparator A volume of 18 mL (Nine 2 mL vials) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly	Drug: Phosphate-buffered saline A volume of 18 mL (nine 2 mL vials of normal saline) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly for 52 weeks

Eligibility

Ages Eligible for Study:	12 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Systemic Lupus Erythematosus (SLE)
Active SLE renal disease within past 4 years.
Males or females between 12 and 70 years old.
Females must be non-pregnant and non-lactating. Females and males must use adequate birth control methods during course of study.
Ability to have weekly intravenous (IV) administration of study treatment.

Exclusion Criteria:

Active SLE renal disease within past 3 months prior to entering study.
Use of the following therapies within 3 months prior to entering the study: alkylating agents, e.g., cyclophosphamide, TNF inhibitors, cyclosporine.
Use of mycophenolate mofetil that exceeds 1000 mg/day, azathioprine that exceeds 100 mg/day, methotrexate that exceeds 10 mg/week, leflunomide that exceeds 10 mg/day within 2 months prior to entering study.
Use of rituximab within 6 months prior to entering study.
Current abuse of drugs or alcohol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089804

Contacts

Contact: Michael J Tansey, MD

858-452-6600

Show 199 Study Locations

Sponsors and Collaborators

La Jolla Pharmaceutical Company

Investigators

Study Director:

Michael J Tansey, MD, Ph.D.

Chief Medical Officer, La Jolla Pharmaceutical Company

More Information

Sponsor's website This link exits the ClinicalTrials.gov site

Responsible Party:	La Jolla Pharmaceutical Company ( Michael J. Tansey, Chief Medical Officer )
Study ID Numbers:	LJP 394-90-14
Study First Received:	August 13, 2004
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00089804
Health Authority:	United States: Food and Drug Administration

Keywords provided by La Jolla Pharmaceutical Company:

Lupus
Nephritis
Kidney

SLE
Systemic Lupus Erythematosus
Nephritis, Lupus

Study placed in the following topic categories:

Glomerulonephritis
Autoimmune Diseases
Urologic Diseases
Lupus Erythematosus, Systemic

Lupus Nephritis
Nephritis
Connective Tissue Diseases
Kidney Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009