NCT00089804

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 943 (actual)
• Sponsor: La Jolla Pharmaceutical Company · Industry
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lupus Erythematosus, Systemic
• Lupus Nephritis

Interventions

Type	Name	Description
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
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.
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

Timeline

• Start date: 2004-10-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2004-08-17
• Last updated: 2009-04-01

Locations

201 sites across 30 countries: United States, Argentina, Australia, Belarus, Brazil, Bulgaria, Czechia, Georgia, Germany, Hong Kong, Hungary, India, Indonesia, Italy, Lebanon, Malaysia, Mexico, Philippines, Poland, Portugal, Puerto Rico, Romania, Serbia, Slovakia, South Korea, Spain, Sri Lanka, Taiwan, Thailand, Ukraine