Study of Safety and Efficacy of ANG-3070 in Chronic Kidney Disease

Proteinuria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04939116
• Other study ID #: ANG3070-CKD-201
• Status: Recruiting
• Phase: Phase 2
• Start date: December 24, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: March 2022
• Source: Angion Biomedica Corp
• Contact: Brandy Dupee
• Phone: 857-378-4302
• Email: bdupee[@]angion.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The major objective is to demonstrate the safety and efficacy of ANG-3070 in patients with primary glomerular disease and persistent proteinuria.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female participants aged 18 and older.

2. 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.

3. Estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) = 40 mL/min/1.73m2.

4. Urinary protein excretion = 1 g/day on a 24-hour urine collection.

5. All participants must be on the SOC therapy, including the maximally tolerated/recommended doses of an ACEi or ARB, but not both.

Exclusion Criteria:

1. Positive Hepatitis B (HBV), Hepatitis C (HCV), or human immunodeficiency virus (HIV) viral screening; historical or during screening.

2. Aspartate Aminotransferase (AST) or alanine Aminotransferase (ALT) or total bilirubin > 2 x ULN.

3. Hemoglobin A1C > 8.5%.

4. Known predisposition to bleeding and/or thrombosis

5. Type I diabetes mellitus.

6. 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.

Related Conditions & MeSH terms

• Glomerular Disease
• Proteinuria

Intervention

Drug:
• ANG-3070
Orally administered tyrosine kinase inhibitor capsule
• Placebo
Orally administered placebo capsule

Locations

Country	Name	City	State
Australia	St Vincent's Hospital Melbourne	Fitzroy	Victoria
Australia	Nepean Hospital	Kingswood	New South Wales
Australia	Austin Health	Melbourne	Victoria
Australia	John Hunter Hospital	New Lambton	New South Wales
Australia	Western Hospital	Saint Albans	Victoria
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Georgia	JSC "Evex Hospitals"	Kutaisi
Georgia	"Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies" LTD	Tbilisi
Georgia	Ivane Bokeria Tbilisi Referral Hospital	Tbilisi
Georgia	LtD Israeli-Georgian Medical Research Clinic Helsicore	Tbilisi
Georgia	Tbilisi Heart Center	Tbilisi
United States	The Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Davita Clinical Research	Columbus	Georgia
United States	Davita Clinical Research	Edina	Minnesota
United States	Prolato Clinical Research Center	Houston	Texas
United States	New Jersey Kidney Care	Jersey City	New Jersey
United States	Clinical Research Consultants, LLC.	Kansas City	Missouri
United States	South Florida Research Institute	Lauderdale Lakes	Florida
United States	NYU Langone Nephrology Associates	Mineola	New York
United States	Amicis Reserach Center	Northridge	California
United States	Amicis Reserach Center	Northridge	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Frenova Renal Research/Nephrology and Hypertension Specialists	Saint Louis	Missouri
United States	St. Louis Kidney Care	Saint Louis	Missouri
United States	Genesis Clinical Research LLC	Tampa	Florida
United States	Amicis Reserach Center	Vacaville	California

Sponsors (1)

Lead Sponsor	Collaborator
Angion Biomedica Corp

Countries where clinical trial is conducted

United States,  Australia,  Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in 24-hour urinary protein excretion at Week 12		Week 12