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Study of LJP 394 in Lupus Patients With History of Renal Disease (ASPEN)

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ClinicalTrials.gov Identifier: NCT00089804
Recruitment Status : Terminated (Interim efficacy analysis indicated it would be futile to continue study.)
First Posted : August 17, 2004
Last Update Posted : April 1, 2009
Sponsor:
Information provided by:
La Jolla Pharmaceutical Company

Brief Summary:
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 or disease Intervention/treatment 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 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 943 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : October 2004
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009


Arm Intervention/treatment
Active Comparator: 1
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
Active Comparator: 2
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.
Placebo Comparator: 3
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
Other Name: Placebo, normal saline



Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00089804


  Show 201 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

Additional Information:
Responsible Party: Michael J. Tansey, Chief Medical Officer, La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier: NCT00089804     History of Changes
Other Study ID Numbers: LJP 394-90-14
First Posted: August 17, 2004    Key Record Dates
Last Update Posted: April 1, 2009
Last Verified: March 2009

Keywords provided by La Jolla Pharmaceutical Company:
Lupus
Nephritis
Kidney
SLE
Systemic Lupus Erythematosus
Nephritis, Lupus

Additional relevant MeSH terms:
Kidney Diseases
Lupus Erythematosus, Systemic
Nephritis
Lupus Nephritis
Urologic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Glomerulonephritis