BG9588 (Anti-CD40L Antibody) to Treat Lupus Nephritis

You may be eligible if

• Must give written informed consent prior to any testing under this protocol.
• Must be 18 years or older, inclusive, at the time of informed consent.
• Must have a renal biopsy showing active WHO Class III, IV, or mixed membranous and proliferative SLE GN, within the 5 years prior to the first dose of study drug.
• Must have proteinuria of greater than or equal to 1.0 g/day at both the Day-27 and day-13 evaluations.
• Must fulfill any one the following four criteria, at each of the two screening visits (i.e., Day-27 and Day-13):
• Anti-dsDNA antibody greater than 2x the upper limit of normal (ULN).
• C3 complement less than 80 mg/dL.
• Hematuria greater than 5 rbc/hpf.
• Urinary granular or red blood cell casts.
• Must not have any medical disorder, which in the opinion of the investigator, should exclude the subject from this study.
• Must not have prior arterial or venous thrombosis, or history of recurrent abortion (3 or more), in the presence of anti-cardiolipin antibodies.
• Must not have a chest x-ray with evidence of active infection or neoplasm within the 6 months prior to the first dose of study drug.
• Must not have rapidly progressive glomerulonephritis, defined as a doubling of serum creatinine, within the 3 months prior to the first dose of study drug.
• Must not have fibrinoid necrosis and/or cellular crescents affecting more than 25 percent of glomeruli in any renal biopsy performed within the 3 months prior to the first dose of study drug.
• Must not have clinically significant findings for any of the following within the 4 weeks prior to the first dose of study drug: active psychiatric disease, serum creatinine greater than 2.0 mg/dL, prothrombin time (PT) greater than 1.3x control (in the absence of coumadin therapy; abnormal PT values due to anti-coagulation therapy are allowed if within the therapeutic range), AST or ALT levels greater than 3x normal, other major organ dysfunction, or serious local or systemic infection (e.g., pneumonia, septicemia).
• Must not be positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HVC Ab), or HIV antibody at the Day-27 evaluation.
• Must not have a mean CD4 count less than or equal to 300 microliters (mean of Day-27 and Day-13 results).
• Must not have treatment with an antibody or other investigational drug within the 3 months prior to the first dose of the study drug.
• Must not have any vaccination within the 4 weeks prior to the first dose of the study drug.
• Must not have treatment with IV or oral cyclophosphamide within the 4 weeks prior to the first dose of the study drug.
• Must not have treatment with any of the following medications within the 4 weeks prior to the first dose of study drug: IV methylprednisolone, cyclosporine or related compound, or oral prednisone (equivalent oral glucocorticoid) at a dose greater than 0.5 mg/kg/day.
• Must not have initiation of treatment with ACE inhibitors within the 4 weeks prior to the first dose of study drug.
• Must not have initiation of treatment with azathioprine, methotrexate or mycophenolate mofetil within the 4 weeks prior to the first dose of study drug.
• Must not have treatment with any new oral or new IV antibiotic within the 2 weeks prior to the first dose of study drug. Subjects on prophylactic antibiotics are permitted to continue these during the study.
• Female subjects, unless post-menopausal or surgically sterile, must use an adequate method of contraception.
• Women must not be currently breast-feeding.
• Must not have a positive pregnancy test in any evaluation prior to the first dose of study drug.
• Must not be currently enrolled in any other study in which the subject is receiving any type of drug or non-drug therapy.
• Must not have been previously dosed with BG9588.