Study of Safety and Efficacy of ANG-3070 in Chronic Kidney Disease
A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Safety and Efficacy of ANG-3070 in Patients With Primary Glomerular Disease and Persistent Proteinuria
1 other identifier
interventional
100
3 countries
30
Brief Summary
The major objective is to demonstrate the safety and efficacy of ANG-3070 in patients with primary glomerular disease and persistent proteinuria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2021
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2021
CompletedFirst Posted
Study publicly available on registry
June 25, 2021
CompletedStudy Start
First participant enrolled
December 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedMarch 23, 2022
March 1, 2022
1.6 years
June 17, 2021
March 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage change in 24-hour urinary protein excretion at Week 12
Week 12
Study Arms (4)
200 mg QD
EXPERIMENTAL200 mg of ANG-3070 will be taken once daily for 12 weeks.
400 mg QD
EXPERIMENTAL400 mg of ANG-3070 will be taken once daily for 12 weeks
300 mg BID
EXPERIMENTAL300 mg of ANG-3070 will be taken twice a day for 12 weeks.
Placebo
PLACEBO COMPARATORPlacebo capsules will be taken once or twice daily for 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Amicis Reserach Center
Northridge, California, 91324, United States
Amicis Reserach Center
Northridge, California, 91324, United States
Amicis Reserach Center
Vacaville, California, 95687, United States
South Florida Research Institute
Lauderdale Lakes, Florida, 33313, United States
Genesis Clinical Research LLC
Tampa, Florida, 33603, United States
Davita Clinical Research
Columbus, Georgia, 31904, United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02108, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Davita Clinical Research
Edina, Minnesota, 55435, United States
Clinical Research Consultants, LLC.
Kansas City, Missouri, 64111, United States
Frenova Renal Research/Nephrology and Hypertension Specialists
St Louis, Missouri, 63017, United States
St. Louis Kidney Care
St Louis, Missouri, 63136, United States
New Jersey Kidney Care
Jersey City, New Jersey, 07305, United States
NYU Langone Nephrology Associates
Mineola, New York, 11501, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Prolato Clinical Research Center
Houston, Texas, 77054, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
John Hunter Hospital
New Lambton, New South Wales, 2305, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
Austin Health
Melbourne, Victoria, 3102, Australia
Western Hospital
Saint Albans, Victoria, 3021, Australia
JSC "Evex Hospitals"
Kutaisi, 4600, Georgia
LtD Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, 0112, Georgia
"Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies" LTD
Tbilisi, 0144, Georgia
Ivane Bokeria Tbilisi Referral Hospital
Tbilisi, 0177, Georgia
Tbilisi Heart Center
Tbilisi, 0186, Georgia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
John Neylan, MD
Angion Biomedica
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2021
First Posted
June 25, 2021
Study Start
December 24, 2021
Primary Completion
July 31, 2023
Study Completion
August 31, 2023
Last Updated
March 23, 2022
Record last verified: 2022-03