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

March 22, 2022 updated by: Angion Biomedica Corp

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Kingswood, New South Wales, Australia, 2747
        • Recruiting
        • Nepean Hospital
        • Principal Investigator:
          • Bhadran Bose
        • Contact:
      • New Lambton, New South Wales, Australia, 2305
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Recruiting
        • St Vincent's Hospital Melbourne
        • Contact:
        • Principal Investigator:
          • Sharon Ford
      • Melbourne, Victoria, Australia, 3102
        • Recruiting
        • Austin Health
        • Contact:
      • Saint Albans, Victoria, Australia, 3021
        • Recruiting
        • Western Hospital
        • Principal Investigator:
          • Eugenia Pedagogos
        • Contact:
          • Shannon Kokoszka, BN, RN, MN
        • Contact:
  • Georgia
      • Kutaisi, Georgia, 4600
        • Recruiting
        • JSC "Evex Hospitals"
        • Contact:
        • Principal Investigator:
          • Marina Dadunashvili
      • Tbilisi, Georgia, 0112
        • Recruiting
        • LTD Israeli-Georgian Medical Research Clinic Helsicore
        • Contact:
        • Principal Investigator:
          • Avtandil Tataradze
      • Tbilisi, Georgia, 0144
        • Recruiting
        • "Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies" LTD
        • Contact:
        • Principal Investigator:
          • Irma Tchokhonelidze
      • Tbilisi, Georgia, 0177
        • Recruiting
        • Ivane Bokeria Tbilisi Referral Hospital
        • Contact:
        • Principal Investigator:
          • Nino Maglakelidze
      • Tbilisi, Georgia, 0186
        • Recruiting
        • Tbilisi Heart Center
        • Contact:
        • Principal Investigator:
          • Ketevan Tsanava
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Not yet recruiting
        • University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Arun Rajasekaren, M.D.
    • California
      • Northridge, California, United States, 91324
        • Recruiting
        • Amicis Reserach Center
        • Contact:
        • Principal Investigator:
          • Anant Desai, M.D.,MBBS,GCE
      • Vacaville, California, United States, 95687
        • Recruiting
        • Amicis Reserach Center
        • Contact:
        • Principal Investigator:
          • Piangwarin Phaosawasdi, M.D.
    • Florida
      • Lauderdale Lakes, Florida, United States, 33313
        • Recruiting
        • South Florida Research Institute
        • Contact:
        • Principal Investigator:
          • Edouard Martin, M.D.,MBBS
      • Tampa, Florida, United States, 33603
        • Recruiting
        • Genesis Clinical Research LLC
        • Contact:
        • Principal Investigator:
          • Jesus Navarro, M.D.
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Recruiting
        • DaVita Clinical Research
        • Contact:
        • Principal Investigator:
          • Vinayak Ramanath, M.D.,MBBS
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Not yet recruiting
        • The Johns Hopkins Hospital
        • Contact:
          • Mohamed Atta, M.B.B.Ch., M.D., M.P.H.
          • Phone Number: 319-384-9534
          • Email: matta1@jhmi.edu
        • Principal Investigator:
          • Mohamed Atta, M.B.B.Ch., M.D., M.P.H.
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
        • Principal Investigator:
          • Theodore Steinman, M.D.
      • Boston, Massachusetts, United States, 02108
        • Not yet recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Meghan Sise, M.D.,M.S
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • DaVita Clinical Research
        • Contact:
        • Principal Investigator:
          • Johnathan Tollins, M.D.
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Clinical Research Consultants, LLC.
        • Contact:
        • Principal Investigator:
          • Ahmed Awad, D.O.
      • Saint Louis, Missouri, United States, 63017
        • Recruiting
        • Frenova Renal Research/Nephrology and Hypertension Specialists
        • Contact:
        • Principal Investigator:
          • John Mellas, M.D.
      • Saint Louis, Missouri, United States, 63136
        • Recruiting
        • St. Louis Kidney Care
        • Contact:
        • Principal Investigator:
          • Donovan Polack, M.D.
    • New Jersey
      • Jersey City, New Jersey, United States, 07305
        • Recruiting
        • New Jersey Kidney Care
        • Contact:
        • Principal Investigator:
          • Deepika Jain, M.D.
    • New York
      • Mineola, New York, United States, 11501
        • Not yet recruiting
        • NYU Langone Nephrology Associates
        • Contact:
        • Principal Investigator:
          • James Drakakis, D.O.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • University of Pennsylvania
        • Contact:
        • Principal Investigator:
          • Abdallah Geara, M.D.
    • Texas
      • Houston, Texas, United States, 77054
        • Not yet recruiting
        • Prolato Clinical Research Center
        • Contact:
        • Principal Investigator:
          • Biruh Workeneh, M.D.
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Not yet recruiting
        • University of Vermont Medical Center
        • Contact:
        • Principal Investigator:
          • Richard Solomon, M.D.,B.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 200 mg QD
200 mg of ANG-3070 will be taken once daily for 12 weeks.
Drug: ANG-3070
Orally administered tyrosine kinase inhibitor capsule
Experimental: 400 mg QD
400 mg of ANG-3070 will be taken once daily for 12 weeks
Drug: ANG-3070
Orally administered tyrosine kinase inhibitor capsule
Experimental: 300 mg BID
300 mg of ANG-3070 will be taken twice a day for 12 weeks.
Drug: ANG-3070
Orally administered tyrosine kinase inhibitor capsule
Placebo Comparator: Placebo
Placebo capsules will be taken once or twice daily for 12 weeks.
Drug: Placebo
Orally administered placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage change in 24-hour urinary protein excretion at Week 12
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angion Biomedica Corp

Investigators

  • Study Director: John Neylan, MD, Angion Biomedica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2021

Primary Completion (Anticipated)

July 31, 2023

Study Completion (Anticipated)

August 31, 2023

Study Registration Dates

First Submitted

June 17, 2021

First Submitted That Met QC Criteria

June 17, 2021

First Posted (Actual)

June 25, 2021

Study Record Updates

Last Update Posted (Actual)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANG3070-CKD-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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