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

NCT ID: NCT04042623

Last Updated: 2022-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-27
• Study Completion Date: 2020-08-01

Brief 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.

Conditions

IgA Nephropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment with AVB-S6-500

Patients will receive AVB-S6-500 by intravenous infusion every 2 weeks for total of 6 doses.

Group Type: EXPERIMENTAL

AVB-S6-500

Intervention Type: DRUG

AVB-S6-500 is experimental drug

Interventions

AVB-S6-500

AVB-S6-500 is experimental drug

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aravive, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francoise Desir

Role: STUDY_DIRECTOR

Aravive, Inc.

Locations

Moonshine Clinical Research

Doral, Florida, United States

Institute of Nephrology National Academy of Medical Science Ukraine

Kyiv, , Ukraine

Countries

United States; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AVB500-IGA-001

Identifier Type: -

Identifier Source: org_study_id