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

NCT04042623 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: AVB500-IGA-001
• Study Type: interventional
• Target: 1
• Locations: 2 countries
• Sites: 2

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

Keywords

IgAN; AXL inhibitor; Berger's Disease; Proteinuria; Kidney Disease

Outcome Measures

Primary Outcomes (7)

• Incidence of Adverse Events (AEs)

  Measured by the number of patients with AEs

  14 weeks

• The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in 24-hour Urine Protein Excretion (UPE) in g/Day.

  12 weeks

• The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in 24-hour Urine Protein Excretion (UPE) in g/Day in the Subset of Patients With Baseline High Proteinuria.

  12 weeks

• The Effect of AVB-S6-500 on Proportion of Patients With Urinary Protein Equivalent of < 1 g/24 Hours at End of Treatment

  12 weeks

• The Effect of AVB-S6-500 on Proportion of Patients Who Had at Least a Decrease of 0.5 g/Day Proteinuria From Baseline to End of Treatment.

  12 weeks

• The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in Urine Albumin/Creatinine Ratios (uACRs).

  12 weeks

• The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in Estimated Glomerular Filtration Rate (eGFR).

  12 weeks

Secondary Outcomes (6)

• Incidence of Anti-drug Antibody (ADA)

  14 weeks

• Titers of Anti-AVB-S6-500 Antibodies

  14 weeks

• Apparent Terminal Half-life (t1/2) of AVB-S6-500

  12 weeks

• Maximum Observed Plasma Concentration of AVB-S6-500 (Cmax)

  12 weeks

• Area Under Time-concentration Curve (AUC)

  12 weeks

Study Arms (1)

Treatment with AVB-S6-500

EXPERIMENTAL

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

Drug: AVB-S6-500

Interventions

AVB-S6-500 DRUG

AVB-S6-500 is experimental drug

Treatment with AVB-S6-500

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aravive, Inc.: lead

Study Sites (2)

Moonshine Clinical Research

Doral, Florida, 33166, United States

Location

Institute of Nephrology National Academy of Medical Science Ukraine

Kyiv, 04050, Ukraine

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA; Proteinuria; Kidney Diseases

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

After enrollment of one subject, the study was paused due to the COVID-19 pandemic. Subsequently, the sponsor terminated the study due to a change in sponsor priorities.

Results Point of Contact

• Title: Dr. Reshma Rangwala, Chief Medical Officer
• Organization: Aravive

rrangwala@aravive.com

936-355-1910

Study Officials

• Francoise Desir

  Aravive, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 2, 2019
• Study Start: November 27, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: February 10, 2022
• Results First Posted: February 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); UA (1)