search
Back to results

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

Primary Purpose

Glomerular Disease, Proteinuria

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ANG-3070
Placebo
Sponsored by
Angion Biomedica Corp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glomerular Disease focused on measuring Glomerular Disease, Chronic Kidney Disease, Proteinuria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Amicis Reserach CenterRecruiting
  • Amicis Reserach CenterRecruiting
  • Amicis Reserach CenterRecruiting
  • South Florida Research InstituteRecruiting
  • Genesis Clinical Research LLCRecruiting
  • Davita Clinical ResearchRecruiting
  • The Johns Hopkins Hospital
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Davita Clinical ResearchRecruiting
  • Clinical Research Consultants, LLC.Recruiting
  • Frenova Renal Research/Nephrology and Hypertension SpecialistsRecruiting
  • St. Louis Kidney CareRecruiting
  • New Jersey Kidney CareRecruiting
  • NYU Langone Nephrology Associates
  • University of Pennsylvania
  • Prolato Clinical Research Center
  • University of Vermont Medical Center
  • Nepean HospitalRecruiting
  • John Hunter HospitalRecruiting
  • Princess Alexandra HospitalRecruiting
  • St Vincent's Hospital MelbourneRecruiting
  • Austin HealthRecruiting
  • Western HospitalRecruiting
  • JSC "Evex Hospitals"Recruiting
  • LtD Israeli-Georgian Medical Research Clinic HelsicoreRecruiting
  • "Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies" LTDRecruiting
  • Ivane Bokeria Tbilisi Referral HospitalRecruiting
  • Tbilisi Heart CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

200 mg QD

400 mg QD

300 mg BID

Placebo

Arm Description

200 mg of ANG-3070 will be taken once daily for 12 weeks.

400 mg of ANG-3070 will be taken once daily for 12 weeks

300 mg of ANG-3070 will be taken twice a day for 12 weeks.

Placebo capsules will be taken once or twice daily for 12 weeks.

Outcomes

Primary Outcome Measures

Percentage change in 24-hour urinary protein excretion at Week 12

Secondary Outcome Measures

Full Information

First Posted
June 17, 2021
Last Updated
March 22, 2022
Sponsor
Angion Biomedica Corp
search

1. Study Identification

Unique Protocol Identification Number
NCT04939116
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 24, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Angion Biomedica Corp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glomerular Disease, Proteinuria
Keywords
Glomerular Disease, Chronic Kidney Disease, Proteinuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
200 mg QD
Arm Type
Experimental
Arm Description
200 mg of ANG-3070 will be taken once daily for 12 weeks.
Arm Title
400 mg QD
Arm Type
Experimental
Arm Description
400 mg of ANG-3070 will be taken once daily for 12 weeks
Arm Title
300 mg BID
Arm Type
Experimental
Arm Description
300 mg of ANG-3070 will be taken twice a day for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules will be taken once or twice daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
ANG-3070
Intervention Description
Orally administered tyrosine kinase inhibitor capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Orally administered placebo capsule
Primary Outcome Measure Information:
Title
Percentage change in 24-hour urinary protein excretion at Week 12
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brandy Dupee
Phone
857-378-4302
Email
bdupee@angion.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Neylan, MD
Organizational Affiliation
Angion Biomedica
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arun Rajasekaren, M.D.
Phone
205-934-1432
Email
arajasekaran@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Arun Rajasekaren, M.D.
Facility Name
Amicis Reserach Center
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Billy Hour, M.D.
Phone
818-924-4708
Email
billy.hour@amicisresearch.com
First Name & Middle Initial & Last Name & Degree
Billy Hour, M.D.
Facility Name
Amicis Reserach Center
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anant Desai, M.D.,MBBS,GCE
Phone
818-366-4632
Email
a.desai@amicisresearch.com
First Name & Middle Initial & Last Name & Degree
Anant Desai, M.D.,MBBS,GCE
Facility Name
Amicis Reserach Center
City
Vacaville
State/Province
California
ZIP/Postal Code
95687
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piangwarin Phaosawasdi, M.D.
Phone
818-929-7774
Email
p.phaosawasdi@amicisresearch.com
First Name & Middle Initial & Last Name & Degree
Piangwarin Phaosawasdi, M.D.
Facility Name
South Florida Research Institute
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edouard Martin, M.D.,MBBS
Phone
706-596-8222
Email
Vramanath79@gmail.com
First Name & Middle Initial & Last Name & Degree
Edouard Martin, M.D.,MBBS
Facility Name
Genesis Clinical Research LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus Navarro, M.D.
Phone
813-873-1016
Email
drnpi@genesistrials.com
First Name & Middle Initial & Last Name & Degree
Jesus Navarro, M.D.
Facility Name
Davita Clinical Research
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vinayak Ramanath, M.D.,MBBS
Phone
706-596-8222
Email
Vramanath79@gmail.com
First Name & Middle Initial & Last Name & Degree
Vinayak Ramanath, M.D.,MBBS
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Atta, M.B.B.Ch., M.D., M.P.H.
Phone
319-384-9534
Email
matta1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Mohamed Atta, M.B.B.Ch., M.D., M.P.H.
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02108
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan Sise, M.D.,M.S.
Phone
617-643-0312
Email
msise@partners.org
First Name & Middle Initial & Last Name & Degree
Meghan Sise, M.D.,M.S
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theodore Steinman, M.D.
Phone
617-632-1070
Email
tsteinma@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Theodore Steinman, M.D.
Facility Name
Davita Clinical Research
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johnathan Tollins, M.D.
Phone
612-508-9938
Email
jtolins@comcast.net
First Name & Middle Initial & Last Name & Degree
Johnathan Tollins, M.D.
Facility Name
Clinical Research Consultants, LLC.
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Awad, D.O.
Phone
816-756-1222
Email
awada@crckcmo.com
First Name & Middle Initial & Last Name & Degree
Ahmed Awad, D.O.
Facility Name
Frenova Renal Research/Nephrology and Hypertension Specialists
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Mellas, M.D.
Phone
217-372-4038
Email
johnmellas56@gmail.com
First Name & Middle Initial & Last Name & Degree
John Mellas, M.D.
Facility Name
St. Louis Kidney Care
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donovan Polack, M.D.
Phone
314-225-9937
Email
donovanp@sbcglobal.net
First Name & Middle Initial & Last Name & Degree
Donovan Polack, M.D.
Facility Name
New Jersey Kidney Care
City
Jersey City
State/Province
New Jersey
ZIP/Postal Code
07305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deepika Jain, M.D.
Phone
917-920-0580
Email
Deepika.Jain@fmc-na.com
First Name & Middle Initial & Last Name & Degree
Deepika Jain, M.D.
Facility Name
NYU Langone Nephrology Associates
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Drakakis, D.O.
Phone
516-663-9041
Email
james.drakakis@nyulangone.org
First Name & Middle Initial & Last Name & Degree
James Drakakis, D.O.
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdallah Geara, M.D.
Phone
215-662-2638
Email
geara@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Abdallah Geara, M.D.
Facility Name
Prolato Clinical Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Biruh Workeneh, M.D.
Phone
832-338-9118
Email
btworkeneh@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Biruh Workeneh, M.D.
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Solomon, M.D., B.A.
Phone
802-847-3734
Email
richard.solomon@uvmhealth.org
First Name & Middle Initial & Last Name & Degree
Richard Solomon, M.D.,B.A.
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhadran Bose, MD
Phone
02 4734 3814
Email
bhadran.bose@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Bhadran Bose
Facility Name
John Hunter Hospital
City
New Lambton
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruce MacKinnon, MB. ChB, M.D., FRCP
Phone
+61 2 49214321
Email
Malcolm.Mackinnon@health.nsw.gov.au
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Leary, BA, BN
Phone
07 3176 6325
Email
Diana.leary@health.qld.gov.au
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharron H Ford, M.D.
Phone
+61394194077
Email
sharon.ford@svha.org.au
First Name & Middle Initial & Last Name & Degree
Sharon Ford
Facility Name
Austin Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3102
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Mount, MBBS, B Med Sci, Ph.D.,
Phone
03 9496 3059
Email
peter.mount@austin.org.au
Facility Name
Western Hospital
City
Saint Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Kokoszka, BN, RN, MN
Phone
+61 466 419 851
Email
Shannon.Kokoszka@wh.org.au
First Name & Middle Initial & Last Name & Degree
Eugenia Pedagogos
Facility Name
JSC "Evex Hospitals"
City
Kutaisi
ZIP/Postal Code
4600
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anri Kapanadze, Executive director
Phone
+995 599383322
Email
Kapanadze.a@evex.ge
First Name & Middle Initial & Last Name & Degree
Marina Dadunashvili
Facility Name
LtD Israeli-Georgian Medical Research Clinic Helsicore
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shmagi Tchiokadze, Executive director
Phone
+995 577771232
Email
Sh.tchiokadze@hcore.ge
First Name & Middle Initial & Last Name & Degree
Avtandil Tataradze
Facility Name
"Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies" LTD
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giorgi Ingorokva, Executive director
Phone
+995 595105454
Email
gocha.ingorokva@gmail.com
First Name & Middle Initial & Last Name & Degree
Irma Tchokhonelidze
Facility Name
Ivane Bokeria Tbilisi Referral Hospital
City
Tbilisi
ZIP/Postal Code
0177
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anri Kapanadze, Executive director
Phone
+995 599383322
Email
Kapanadze.a@evex.ge
First Name & Middle Initial & Last Name & Degree
Nino Maglakelidze
Facility Name
Tbilisi Heart Center
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergo Sakvarelidze, Executive director
Phone
+995 577224454
Email
sergosakvarelidze@tbhc.ge
First Name & Middle Initial & Last Name & Degree
Ketevan Tsanava

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs