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

Aravive

Status and phase

Terminated

Phase 2

Conditions

IgA Nephropathy

Treatments

Drug: AVB-S6-500

Study type

Interventional

Funder types

Industry

Identifiers

NCT04042623

AVB500-IGA-001

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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