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 - ND

• Conditions: Systemic lupus erithematosus (SLE) patients with a history of renal disease.; MedDRA version: 9.1Level: LLTClassification code 10042945Term: Systemic lupus erythematosus

• Registration Number: EUCTR2006-000674-73-IT
• Lead Sponsor: A JOLLA PHARMACEUTICAL COMPANY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 730

Inclusion Criteria

Males or females between 12 and 70 years old inclusive. Female patients must have a negative pregnancy test. Diagnii'osis of SLE established when > or equal 4 of the 11 criteria are met based on the classification of the American College of Rheumatology. At least one documented episode of active SLE renal disease within 4 years prior to randomization. Elevated anti dsDNA antibody concentration at pre-screening visit as measured by Farr assay.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Active SLE renal disease in the 3 months prior to randomization. An increase in the anti sdDNA antibody concentration of more than 50% of the former sample. Use of the following therapeutics: prednisone, alkylating agents, TNF inhibitors, cyclosporine, plasmapheresis, intravenous immnoglobulin, prosorba column, mycophenolate mofetil, azathioprine, methotrexate, leflunomide, rituximab. laboratory values: leukocyte count < 2000 cells/mm3, platelet count < 50000 cells/mm3, hemoglobin < 8.5 gr/dl transaminases > 3X the upper limit of normal, serum creatinine > 3.5 mg/dL. Immunodeficiency syndrome within 5 years. Evidence of current abuse of drugs or alcohol. Serious cardiac disease. Patients has previously undergone organ transplantation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether Abetimus sodium is more effective than placebo in delaying the time to renal flare in SLE patients with a hostory of SLE renal disease.;Secondary Objective: To determine whether treatment with Abetimus sodium is more effective than placebo in reducing proteinuria and in delaying time to all mejor SLE flares.;Primary end point(s): The primary efficacy endpoint is the time to first renal flare. Safety and tolerability endpoints are the collections of adverse experiences, laboratory parameters, reasons for premature study termination and cause of death.