Status:
TERMINATED
Study of Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy
Lead Sponsor:
Aravive, Inc.
Conditions:
IgA Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 do...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04042623
Start Date
November 27 2019
End Date
August 1 2020
Last Update
February 10 2022
Active Locations (2)
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1
Moonshine Clinical Research
Doral, Florida, United States, 33166
2
Institute of Nephrology National Academy of Medical Science Ukraine
Kyiv, Ukraine, 04050