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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04042623
Recruitment Status : Terminated (Business reasons)
First Posted : August 2, 2019
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
Aravive, Inc.

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.

Condition or disease Intervention/treatment Phase
IgA Nephropathy Drug: AVB-S6-500 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase 2a Study to Evaluate the Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy
Actual Study Start Date : November 27, 2019
Actual Primary Completion Date : August 1, 2020
Actual Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Treatment with AVB-S6-500
Patients will receive AVB-S6-500 by intravenous infusion every 2 weeks for total of 6 doses.
Drug: AVB-S6-500
AVB-S6-500 is experimental drug




Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: 14 weeks ]
    Measured by the number of patients with AEs

  2. The effect of AVB-S6-500 on change from baseline to End of Treatment in 24-hour urine protein excretion (UPE) in g/day. [ Time Frame: 12 weeks ]
  3. 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. [ Time Frame: 12 weeks ]
  4. The effect of AVB-S6-500 on proportion of patients with urinary protein equivalent of < 1 g/24 hours at End of Treatment [ Time Frame: 12 weeks ]
  5. 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. [ Time Frame: 12 weeks ]
  6. The effect of AVB-S6-500 on change from baseline to End of Treatment in urine albumin/creatinine ratios (uACRs). [ Time Frame: 12 weeks ]
  7. The effect of AVB-S6-500 on change from baseline to End of Treatment in estimated glomerular filtration rate (eGFR). [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Incidence of Anti-drug Antibody (ADA) [ Time Frame: 14 weeks ]
    The number of participants with anti-AVB-S6-500 antibodies

  2. Titers of anti-AVB-S6-500 antibodies [ Time Frame: 14 weeks ]
  3. Apparent terminal half-life (t1/2) of AVB-S6-500 [ Time Frame: 12 weeks ]
  4. Maximum Observed Plasma Concentration of AVB-S6-500 (Cmax) [ Time Frame: 12 weeks ]
  5. Area under time-concentration curve (AUC) [ Time Frame: 12 weeks ]
  6. Time of maximum observed AVB-S6-500 concentration (Tmax) [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04042623


Locations
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United States, Florida
Moonshine Clinical Research
Doral, Florida, United States, 33166
Sponsors and Collaborators
Aravive, Inc.
Investigators
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Study Director: Francoise Desir Aravive, Inc.
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Responsible Party: Aravive, Inc.
ClinicalTrials.gov Identifier: NCT04042623    
Other Study ID Numbers: AVB500-IGA-001
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aravive, Inc.:
IgAN
AXL inhibitor
Berger's Disease
Proteinuria
Kidney Disease
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases