Suspended

ASPENA 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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

abetimus sodium (LJP 394) and/or placebo solution

+ abetimus sodium (LJP 394)

+ Phosphate-buffered saline

Drug
Who is being recruted

Urogenital Diseases+10

+ Autoimmune Diseases

+ Connective Tissue Diseases

From 12 to 70 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: October 2004
See protocol details

Summary

Principal SponsorLa Jolla Pharmaceutical Company
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleA 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 
NCT00089804
Principal SponsorLa Jolla Pharmaceutical Company
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

943 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAutoimmune DiseasesConnective Tissue DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGlomerulonephritisImmune System DiseasesKidney DiseasesLupus Erythematosus, SystemicLupus NephritisNephritisUrologic DiseasesFemale Urogenital DiseasesMale Urogenital Diseases

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Group III

Placebo
A volume of 18 mL (Nine 2 mL vials) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 201 locations

Suspended

University of Alabama at Birmingham

Birmingham, United StatesSee the location
Suspended

Wallace Rheumatic Study Center

Los Angeles, United States
Suspended

East Bay Rheumatology Medical Group

San Leandro, United States
Suspended

Private Practice

San Mateo, United States
Suspended201 Study Centers