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

This study has been terminated.
(Interim efficacy analysis indicated it would be futile to continue study.)
Sponsor:
Information provided by:
La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier:
NCT00089804
First received: August 13, 2004
Last updated: March 30, 2009
Last verified: March 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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 ]

Enrollment: 943
Study Start Date: October 2004
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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

  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
  More Information

Additional Information:
No publications provided

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
Study First Received: August 13, 2004
Last Updated: March 30, 2009
Health Authority: United States: Food and Drug Administration

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
Lupus Nephritis
Nephritis
Urologic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Glomerulonephritis

ClinicalTrials.gov processed this record on April 16, 2014