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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Lupus Erythematosus, Systemic
Kidney Diseases
Nephritis
Lupus Nephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Urologic Diseases
Glomerulonephritis

ClinicalTrials.gov processed this record on September 22, 2014