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

Last updated: March 22, 2022
Sponsor: Angion Biomedica Corp
Overall Status: Active - Recruiting

Phase

2

Condition

Proteinuria

Focal Segmental Glomerulosclerosis

Treatment

N/A

Clinical Study ID

NCT04939116
ANG3070-CKD-201
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 theclinical picture is consistent with the genetic testing results.
  3. Estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease EpidemiologyCollaboration (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 maximallytolerated/recommended doses of an ACEi or ARB, but not both.

Exclusion

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: systemiclupus erythematosus, anti-neutrophil cytoplasmic antibodies -associated diseases,anti-glomerular basement disease, secondary forms of focal segmentalglomerulosclerosis, renal diseases associated with para-proteinemias, C3glomerulopathy, and diabetic kidney disease.

Study Design

Total Participants: 100
Study Start date:
December 24, 2021
Estimated Completion Date:
August 31, 2023

Study 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.

Connect with a study center

  • Nepean Hospital

    Kingswood, New South Wales 2747
    Australia

    Active - Recruiting

  • John Hunter Hospital

    New Lambton, New South Wales 2305
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • Austin Health

    Melbourne, Victoria 3102
    Australia

    Active - Recruiting

  • Western Hospital

    Saint Albans, Victoria 3021
    Australia

    Active - Recruiting

  • JSC "Evex Hospitals"

    Kutaisi, 4600
    Georgia

    Active - Recruiting

  • "Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies" LTD

    Tbilisi, 0144
    Georgia

    Active - Recruiting

  • Ivane Bokeria Tbilisi Referral Hospital

    Tbilisi, 0177
    Georgia

    Active - Recruiting

  • LtD Israeli-Georgian Medical Research Clinic Helsicore

    Tbilisi, 0112
    Georgia

    Active - Recruiting

  • Tbilisi Heart Center

    Tbilisi, 0186
    Georgia

    Active - Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Amicis Reserach Center

    Northridge, California 91324
    United States

    Active - Recruiting

  • Amicis Reserach Center

    Vacaville, California 95687
    United States

    Active - Recruiting

  • South Florida Research Institute

    Lauderdale Lakes, Florida 33313
    United States

    Active - Recruiting

  • Genesis Clinical Research LLC

    Tampa, Florida 33603
    United States

    Active - Recruiting

  • Davita Clinical Research

    Columbus, Georgia 31904
    United States

    Active - Recruiting

  • The Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02108
    United States

    Site Not Available

  • Davita Clinical Research

    Edina, Minnesota 55435
    United States

    Active - Recruiting

  • Clinical Research Consultants, LLC.

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

  • Frenova Renal Research/Nephrology and Hypertension Specialists

    Saint Louis, Missouri 63017
    United States

    Active - Recruiting

  • St. Louis Kidney Care

    Saint Louis, Missouri 63136
    United States

    Active - Recruiting

  • New Jersey Kidney Care

    Jersey City, New Jersey 07305
    United States

    Active - Recruiting

  • NYU Langone Nephrology Associates

    Mineola, New York 11501
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Prolato Clinical Research Center

    Houston, Texas 77054
    United States

    Site Not Available

  • University of Vermont Medical Center

    Burlington, Vermont 05401
    United States

    Site Not Available

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