Study of LJP 394 in Lupus Patients With History of Renal Disease - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 13, 2004

Last Updated Date

March 30, 2009

Start Date ^†

October 2004

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00089804 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Study of LJP 394 in Lupus Patients With History of Renal Disease

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Lupus Erythematosus, Systemic
Lupus Nephritis

Intervention ^†

Drug: abetimus sodium (LJP 394) and/or placebo solution
Drug: abetimus sodium (LJP 394)
Drug: Phosphate-buffered saline

Study Arms / Comparison Groups

Active Comparator: 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: 900 mg (nine 2 mL vials of abetimus sodium) administered i.v. (in the vein) weekly
Placebo Comparator: A volume of 18 mL (Nine 2 mL vials) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Enrollment ^†

943

Completion Date

February 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility 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.

Gender

Both

Ages

12 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Argentina, Australia, Belarus, Brazil, Bulgaria, Czech Republic, Georgia, Germany, Hong Kong, Hungary, India, Indonesia, Italy, Korea, Republic of, Lebanon, Malaysia, Mexico, Philippines, Poland, Portugal, Puerto Rico, Romania, Serbia, Slovakia, Spain, Sri Lanka, Taiwan, Thailand, Ukraine

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00089804

Responsible Party

Michael J. Tansey, Chief Medical Officer, La Jolla Pharmaceutical Company

Secondary IDs ^††

Study Sponsor ^†

La Jolla Pharmaceutical Company

Collaborators ^††

Investigators ^†

Study Director:

Michael J Tansey, MD, Ph.D.

Chief Medical Officer, La Jolla Pharmaceutical Company

Information Provided By

La Jolla Pharmaceutical Company

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.