Clinical Trials Detalhe
Study of LJP 394 in Lupus Patients With History of Renal Disease
General Information
Gender
ALL
Age
from 12 Years to 70 Years
Phase
PHASE3
Study Type
INTERVENTIONAL
Location
Centro Hospitalar de Lisboa Norte, EPE, Hospital de Santa Maria - Reumatologia (Lisbon, Portugal)
Centro Hospitalar do Porto, EPE - Hospital de Santo Antonio, Departamento de Medicina - Unidade de Imunologia Clinica (Porto, Portugal)
Centro Hospitalar de Vila Nova de Gaia (Vila Nova de Gaia, Portugal)
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Egas Moniz, Unidade de Reumatologia (Lisbon, Portugal)
Hospital de Sāo Jeāo, Servico de Nefrologia (Porto, Portugal)
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT00089804Summary
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
Eligibility
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.