Clinical trial NCT04939116: Study of Safety and Efficacy of ANG-3070 in Chronic Kidney Disease
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Glomerular Disease
Proteinuria
Keywords: Glomerular Disease
Chronic Kidney Disease
Proteinuria
Lead sponsor: Angion Biomedica Corp
Sponsor class: INDUSTRY
First posted: 2021-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage change in 24-hour urinary protein excretion at Week 12
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Northridge
country: United States
facility: Amicis Reserach Center
state: California
city: Northridge
country: United States
facility: Amicis Reserach Center
state: California
city: Vacaville
country: United States
facility: Amicis Reserach Center
state: California
city: Lauderdale Lakes
country: United States
facility: South Florida Research Institute
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research LLC
state: Florida
city: Columbus
country: United States
facility: Davita Clinical Research
state: Georgia
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Edina
country: United States
facility: Davita Clinical Research
state: Minnesota
city: Kansas City
country: United States
facility: Clinical Research Consultants, LLC.
state: Missouri
city: Saint Louis
country: United States
facility: Frenova Renal Research/Nephrology and Hypertension Specialists
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Kidney Care
state: Missouri
city: Jersey City
country: United States
facility: New Jersey Kidney Care
state: New Jersey
city: Mineola
country: United States
facility: NYU Langone Nephrology Associates
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: Prolato Clinical Research Center
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: New Lambton
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
city: Saint Albans
country: Australia
facility: Western Hospital
state: Victoria
city: Kutaisi
country: Georgia
facility: JSC "Evex Hospitals"
city: Tbilisi
country: Georgia
facility: LtD Israeli-Georgian Medical Research Clinic Helsicore
city: Tbilisi
country: Georgia
facility: "Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies" LTD
city: Tbilisi
country: Georgia
facility: Ivane Bokeria Tbilisi Referral Hospital
city: Tbilisi
country: Georgia
facility: Tbilisi Heart Center
Study officials:
affiliation: Angion Biomedica
name: John Neylan, MD
role: STUDY_DIRECTOR
References: