Study of Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy
Condition: IgA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Intervention: AVB-S6-500
Intervention description: AVB-S6-500 is experimental drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IgAN; AXL inhibitor; Berger's Disease; Proteinuria; Kidney Disease

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