Study of Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy

Exclusion Criteria

• •Patients with chronic urinary tract infections (UTIs) or taking prophylactic antibiotics to prevent recurrent UTIs
• •Treatment with systemic immunosuppressants, including corticosteroids, within 8 weeks of the first dose of study drug
• •Rapidly progressing nephropathy defined as falling GFR (≥ 15%) over past 3 mos
• •Clinical or biological evidence of diabetes mellitus, systemic lupus erythematosus, IgA vasculitis (Henoch-Schonlein purpura), secondary IgAN, or other renal disease
• •Hemoglobin \< 9.0 g/dL
• •History or clinical evidence of cirrhosis, or liver disease with serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3x upper limit of normal
• •Organ transplant recipient (including bone marrow) or a planned transplant during the study
• •Have a diagnosis of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection, or positive serology at screening
• •Recent active infection requiring hospitalization or i.v. treatment within 30 days prior to the first dose of study drug
• •Received transfusion, plasmapheresis or plasma exchange, IV immunoglobulin (IVIg) within 90 days prior to screening
• •Malignancy within the past 5 years. Exceptions are squamous cell carcinoma of skin, basal cell carcinoma of skin, and cervical carcinoma in situ which have been excised and are considered cured
• •Females who are nursing, pregnant, or intending to become pregnant during the time of the study, or who have a positive pregnancy test at baseline
• •Exposure to an investigational drug or device within 90 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
• •Known sensitivity to any of the products to be administered during dosing
• •Subject will not be available for follow-up assessment
• •Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
• •Prior exposure to AVB-S6-500