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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00089804




Registration number
NCT00089804
Ethics application status
Date submitted
13/08/2004
Date registered
17/08/2004
Date last updated
1/04/2009

Titles & IDs
Public title
Study of LJP 394 in Lupus Patients With History of Renal Disease
Scientific 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
Secondary ID [1] 0 0
LJP 394-90-14
Universal Trial Number (UTN)
Trial acronym
ASPEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lupus Erythematosus, Systemic 0 0
Lupus Nephritis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - abetimus sodium (LJP 394) and/or placebo solution
Treatment: Drugs - abetimus sodium (LJP 394)
Treatment: Drugs - Phosphate-buffered saline

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

Active Comparator: 2 - 900 mg (nine 2 mL vials of abetimus sodium) administered i.v. (in the vein) weekly

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


Treatment: Drugs: 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

Treatment: Drugs: 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.

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Time to event (12 months fixed treatment duration)
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
12 month fixed treatment duration

Eligibility
Key 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.
Minimum age
12 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2009
Sample size
Target
Accrual to date
Final
943
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Rheumatology Clinic - Cairns
Recruitment hospital [2] 0 0
Dept Medicine, Level 3 Wallace Freeborn Building, Royal North Shore Hospital, Pacific Highway - St Leonards
Recruitment hospital [3] 0 0
Vincents Hospital Daly Building, 41 Victoria Parade Fitzroy - Victoria
Recruitment postcode(s) [1] 0 0
QLD 4870 - Cairns
Recruitment postcode(s) [2] 0 0
NSW 2065 - St Leonards
Recruitment postcode(s) [3] 0 0
3065 702 - Victoria
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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California
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Largo Prof. Abel Salazar
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Rua Conceicao Fernandes
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Vinnitsa

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
La Jolla Pharmaceutical Company
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00089804
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael J Tansey, MD, Ph.D.
Address 0 0
Chief Medical Officer, La Jolla Pharmaceutical Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00089804