Study of Safety and Efficacy of ANG-3070 in Chronic Kidney Disease
- Registration Number
- NCT04939116
- Lead Sponsor
- Angion Biomedica Corp
- Brief Summary
The major objective is to demonstrate the safety and efficacy of ANG-3070 in patients with primary glomerular disease and persistent proteinuria.
- Detailed Description
To evaluate the safety and efficacy of ANG-3070 in patients with primary glomerular disease and persistent proteinuria while on the SOC, as measured by a reduction in the 24-hour urinary protein excretion.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Male or female participants aged 18 and older.
- Diagnosis of a primary glomerular disease confirmed from a past renal biopsy. Participants with genetic forms of FSGS may be enrolled without a renal biopsy if the clinical picture is consistent with the genetic testing results.
- Estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) ≥ 40 mL/min/1.73m2.
- Urinary protein excretion ≥ 1 g/day on a 24-hour urine collection.
- All participants must be on the SOC therapy, including the maximally tolerated/recommended doses of an ACEi or ARB, but not both.
- Positive Hepatitis B (HBV), Hepatitis C (HCV), or human immunodeficiency virus (HIV) viral screening; historical or during screening.
- Aspartate Aminotransferase (AST) or alanine Aminotransferase (ALT) or total bilirubin > 2 x ULN.
- Hemoglobin A1C > 8.5%.
- Known predisposition to bleeding and/or thrombosis
- Type I diabetes mellitus.
- Renal disease secondary to systemic disease including but not limited to: systemic lupus erythematosus, anti-neutrophil cytoplasmic antibodies -associated diseases, anti-glomerular basement disease, secondary forms of focal segmental glomerulosclerosis, renal diseases associated with para-proteinemias, C3 glomerulopathy, and diabetic kidney disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 400 mg QD ANG-3070 400 mg of ANG-3070 will be taken once daily for 12 weeks 200 mg QD ANG-3070 200 mg of ANG-3070 will be taken once daily for 12 weeks. 300 mg BID ANG-3070 300 mg of ANG-3070 will be taken twice a day for 12 weeks. Placebo Placebo Placebo capsules will be taken once or twice daily for 12 weeks.
- Primary Outcome Measures
Name Time Method Percentage change in 24-hour urinary protein excretion at Week 12 Week 12
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
The Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
John Hunter Hospital
🇦🇺New Lambton, New South Wales, Australia
St Vincent's Hospital Melbourne
🇦🇺Fitzroy, Victoria, Australia
Prolato Clinical Research Center
🇺🇸Houston, Texas, United States
Ivane Bokeria Tbilisi Referral Hospital
🇬🇪Tbilisi, Georgia
Tbilisi Heart Center
🇬🇪Tbilisi, Georgia
Austin Health
🇦🇺Melbourne, Victoria, Australia
Western Hospital
🇦🇺Saint Albans, Victoria, Australia
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
New Jersey Kidney Care
🇺🇸Jersey City, New Jersey, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Amicis Reserach Center
🇺🇸Vacaville, California, United States
Genesis Clinical Research LLC
🇺🇸Tampa, Florida, United States
South Florida Research Institute
🇺🇸Lauderdale Lakes, Florida, United States
Frenova Renal Research/Nephrology and Hypertension Specialists
🇺🇸Saint Louis, Missouri, United States
St. Louis Kidney Care
🇺🇸Saint Louis, Missouri, United States
Clinical Research Consultants, LLC.
🇺🇸Kansas City, Missouri, United States
NYU Langone Nephrology Associates
🇺🇸Mineola, New York, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Nepean Hospital
🇦🇺Kingswood, New South Wales, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
JSC "Evex Hospitals"
🇬🇪Kutaisi, Georgia
LtD Israeli-Georgian Medical Research Clinic Helsicore
🇬🇪Tbilisi, Georgia
"Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies" LTD
🇬🇪Tbilisi, Georgia
Davita Clinical Research
🇺🇸Edina, Minnesota, United States