BG9588 (Anti-CD40L Antibody) to Treat Lupus Nephritis
Status:
Completed
Trial end date:
2000-05-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)