BG9588 (Anti-CD40L Antibody) to Treat Lupus Nephritis
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|ClinicalTrials.gov Identifier: NCT00001789|
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
The purpose of this study is to investigate whether the experimental drug BG9588 can be used to treat lupus nephritis more effectively and with less toxicity than standard treatments, including cyclophosphamide (Cytoxan), azothioprine (Imuran) and prednisone.
The body's immune system naturally produces antibodies to fight foreign substances like bacteria and viruses. In autoimmune diseases like lupus, however, the body makes antibodies that attack its own tissues, causing inflammation and organ damage. Lupus antibodies attack and damage kidney cells. BG9588 can interfere with the production of these antibodies, and therefore, may lessen kidney damage in people with lupus nephritis.
This study will look at: how BG9588 enters and leaves the blood and body tissue over time; adverse effects of the drug; and whether treatment with BG9588 can result in less kidney damage than other therapies.
Study patients will be receive a 30-minute infusion of BG9588 into a vein every two weeks for three doses and then once every 28 days for four doses. Patients' steroid dosage may be tapered; individual adjustments will be made as required.
Patients screened for the study will undergo a physical examination, medical history, various blood and urine tests, as well as complete a quality of life questionnaire. Results of a previous kidney biopsy and chest X ray are also required. Many of these tests will be repeated throughout the study.
In a previous animal study, BG9588 treatment of mice with lupus nephritis improved their disease and survival.
|Condition or disease||Intervention/treatment||Phase|
|Glomerulonephritis, Membranoproliferative Lupus Nephritis||Drug: BG9588||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Official Title:||An Open-Label, Multiple-Dose Study to Evaluate the Efficacy, Safety and Pharmacokinetics of BG9588 (Anti-CD40L Antibody) in Subjects With Proliferative Lupus Glomerulonephritis (SLE-GN)|
|Study Start Date :||June 1999|
|Estimated Study Completion Date :||May 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001789
|United States, Maryland|
|National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|
|Bethesda, Maryland, United States, 20892|