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

IgA Nephropathy Clinical Trial

Official title:

An Open-Label Phase 2a Study to Evaluate the Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04042623
• Other study ID #: AVB500-IGA-001
• Status: Terminated
• Phase: Phase 2
• Start date: November 27, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: January 2022
• Source: Aravive, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Drug:
• AVB-S6-500
AVB-S6-500 is experimental drug

Locations

Country	Name	City	State
Ukraine	Institute of Nephrology National Academy of Medical Science Ukraine	Kyiv
United States	Moonshine Clinical Research	Doral	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Aravive, Inc.

Countries where clinical trial is conducted

United States,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)	Measured by the number of patients with AEs	14 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in Urine Albumin/Creatinine Ratios (uACRs).		12 weeks
Primary	The Effect of AVB-S6-500 on Change From Baseline to End of Treatment in Estimated Glomerular Filtration Rate (eGFR).		12 weeks
Secondary	Incidence of Anti-drug Antibody (ADA)	The number of participants with anti-AVB-S6-500 antibodies	14 weeks
Secondary	Titers of Anti-AVB-S6-500 Antibodies		14 weeks
Secondary	Apparent Terminal Half-life (t1/2) of AVB-S6-500		12 weeks
Secondary	Maximum Observed Plasma Concentration of AVB-S6-500 (Cmax)		12 weeks
Secondary	Area Under Time-concentration Curve (AUC)		12 weeks
Secondary	Time of Maximum Observed AVB-S6-500 Concentration (Tmax)		12 weeks