MedTrace Logo

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

NCT00089804 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 943

Last updated 2009-04-01

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • La Jolla Pharmaceutical Company

    lead INDUSTRY

Principal Investigators

  • Michael J Tansey, MD, Ph.D. · Chief Medical Officer, La Jolla Pharmaceutical Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2009-02-28
Completion
2009-02-28

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

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00089804 on ClinicalTrials.gov