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:
La Jolla Pharmaceutical Company
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
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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
Show 201 Study LocationsSponsors 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 May 19, 2013