study of safety and efficacy of avb-s6-500 in patients with iga nephropathy

Conditions: IgA Nephropathy

Summary: this is an open-label phase 2a clinical study designed to evaluate the safety and efficacy of avb-s6-500 in patients with iga nephropathy (igan). approximately 24 patients will be enrolled. several dose levels of avb-s6-500 may be evaluated.


Eligibility criteria:
inclusion criteria: * diagnosis of biopsy-proven igan * proteinuria ≥ 1g to 3g/24hr * stable estimated glomerular filtration rate (egfr) for at least 3 months prior to screening and ≥ 45 ml/min per 1.73 m2 using the chronic kidney disease epidemiology collaboration formula * systolic bp lesser than or equal to 150 mmhg and diastolic bp lesser than or equal to 100 mmhg * patients who have been on a steady dose of ace or arb inhibitors for at least 3 months and throughout screening and who are not expected to have their dose adjusted during the study are allowed on study (patients who are not on acei/arb due to inability to tolerate these therapies are also allowed) * if a sexually-active patient, must agree to use a reliable method of birth control from at least 4 weeks prior to first dose of study drug, during the study and for 1 month following completion of therapy. 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

Keywords: igan axl inhibitor berger's disease proteinuria kidney disease