ClinicalTrials.gg
Status unknownNCT04939116Updated Mar 23, 2022

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

A Phase 2 interventional study of ANG-3070 and Placebo in Glomerular Disease and Proteinuria, sponsored by Angion Biomedica Corp. Status unknown at 30 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-23.

Sponsored by Angion Biomedica Corp · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Glomerular Disease
  • Proteinuria

Keywords

  • Glomerular Disease
  • Chronic Kidney Disease
  • Proteinuria
03

In context

Proteinuria

328 studies on the registry are indexed under Proteinuria; 44 are open to participants now.

This study's planned enrollment of 100 is above the median of 54 across 240 interventional studies indexed under Proteinuria.

Browse Proteinuria studies →

Lead sponsor

Angion Biomedica Corp is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female participants aged 18 and older.
  2. Diagnosis of a primary glomerular disease confirmed from a past renal . 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 (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

Exclusion Criteria:

  1. Positive (HBV), (HCV), or (HIV) viral screening; historical or during screening.
  2. (AST) or alanine Aminotransferase (ALT) or total > 2 x .
  3. > 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.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    200 mg QD

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

    Drug: ANG-3070

  • Experimental
    400 mg QD

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

    Drug: ANG-3070

  • Experimental
    300 mg BID

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

    Drug: ANG-3070

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • Orally administered tyrosine kinase inhibitor capsule

  • DrugPlacebo

    Orally administered placebo capsule

06

What researchers measure

Primary outcomes

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

    Time frame: Week 12

07

Study locations

22 of 30 sites recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
    Not yet recruiting
    • Arun Rajasekaren, M.D. · Contactarajasekaran@uabmc.edu · 205-934-1432
    • Arun Rajasekaren, M.D. · Principal investigator
  • Amicis Reserach Center
    Northridge, California 91324, United States
    Recruiting
  • Amicis Reserach Center
    Northridge, California 91324, United States
    Recruiting
    • Anant Desai, M.D.,MBBS,GCE · Contacta.desai@amicisresearch.com · 818-366-4632
    • Anant Desai, M.D.,MBBS,GCE · Principal investigator
  • Amicis Reserach Center
    Vacaville, California 95687, United States
    Recruiting
  • South Florida Research Institute
    Lauderdale Lakes, Florida 33313, United States
    Recruiting
    • Edouard Martin, M.D.,MBBS · ContactVramanath79@gmail.com · 706-596-8222
    • Edouard Martin, M.D.,MBBS · Principal investigator
  • Genesis Clinical Research LLC
    Tampa, Florida 33603, United States
    Recruiting
    • Jesus Navarro, M.D. · Contactdrnpi@genesistrials.com · 813-873-1016
    • Jesus Navarro, M.D. · Principal investigator
  • Davita Clinical Research
    Columbus, Georgia 31904, United States
    Recruiting
    • Vinayak Ramanath, M.D.,MBBS · ContactVramanath79@gmail.com · 706-596-8222
    • Vinayak Ramanath, M.D.,MBBS · Principal investigator
  • The Johns Hopkins Hospital
    Baltimore, Maryland 21287, United States
    Not yet recruiting
    • Mohamed Atta, M.B.B.Ch., M.D., M.P.H. · Contactmatta1@jhmi.edu · 319-384-9534
    • Mohamed Atta, M.B.B.Ch., M.D., M.P.H. · Principal investigator
  • Massachusetts General Hospital
    Boston, Massachusetts 02108, United States
    Not yet recruiting
    • Meghan Sise, M.D.,M.S. · Contactmsise@partners.org · 617-643-0312
    • Meghan Sise, M.D.,M.S · Principal investigator
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
    Not yet recruiting
  • Davita Clinical Research
    Edina, Minnesota 55435, United States
    Recruiting
    • Johnathan Tollins, M.D. · Contactjtolins@comcast.net · 612-508-9938
    • Johnathan Tollins, M.D. · Principal investigator
  • Clinical Research Consultants, LLC.
    Kansas City, Missouri 64111, United States
    Recruiting
    • Ahmed Awad, D.O. · Contactawada@crckcmo.com · 816-756-1222
    • Ahmed Awad, D.O. · Principal investigator
  • Frenova Renal Research/Nephrology and Hypertension Specialists
    Saint Louis, Missouri 63017, United States
    Recruiting
    • John Mellas, M.D. · Contactjohnmellas56@gmail.com · 217-372-4038
    • John Mellas, M.D. · Principal investigator
  • St. Louis Kidney Care
    Saint Louis, Missouri 63136, United States
    Recruiting
    • Donovan Polack, M.D. · Contactdonovanp@sbcglobal.net · 314-225-9937
    • Donovan Polack, M.D. · Principal investigator
  • New Jersey Kidney Care
    Jersey City, New Jersey 07305, United States
    Recruiting
    • Deepika Jain, M.D. · ContactDeepika.Jain@fmc-na.com · 917-920-0580
    • Deepika Jain, M.D. · Principal investigator
  • NYU Langone Nephrology Associates
    Mineola, New York 11501, United States
    Not yet recruiting
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
    Not yet recruiting
  • Prolato Clinical Research Center
    Houston, Texas 77054, United States
    Not yet recruiting
  • University of Vermont Medical Center
    Burlington, Vermont 05401, United States
    Not yet recruiting
  • Nepean Hospital
    Kingswood, New South Wales 2747, Australia
    Recruiting
  • John Hunter Hospital
    New Lambton, New South Wales 2305, Australia
    Recruiting
  • Princess Alexandra Hospital
    Woolloongabba, Queensland 4102, Australia
    Recruiting
  • St Vincent's Hospital Melbourne
    Fitzroy, Victoria 3065, Australia
    Recruiting
  • Austin Health
    Melbourne, Victoria 3102, Australia
    Recruiting
  • Western Hospital
    Saint Albans, Victoria 3021, Australia
    Recruiting
    • Shannon Kokoszka, BN, RN, MN · Contact
    • · ContactShannon.Kokoszka@wh.org.au · +61 466 419 851
    • Eugenia Pedagogos · Principal investigator
  • JSC "Evex Hospitals"
    Kutaisi, 4600, Georgia
    Recruiting
    • Anri Kapanadze, Executive director · ContactKapanadze.a@evex.ge · +995 599383322
    • Marina Dadunashvili · Principal investigator
  • LtD Israeli-Georgian Medical Research Clinic Helsicore
    Tbilisi, 0112, Georgia
    Recruiting
    • Shmagi Tchiokadze, Executive director · ContactSh.tchiokadze@hcore.ge · +995 577771232
    • Avtandil Tataradze · Principal investigator
  • "Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies" LTD
    Tbilisi, 0144, Georgia
    Recruiting
    • Giorgi Ingorokva, Executive director · Contactgocha.ingorokva@gmail.com · +995 595105454
    • Irma Tchokhonelidze · Principal investigator
  • Ivane Bokeria Tbilisi Referral Hospital
    Tbilisi, 0177, Georgia
    Recruiting
    • Anri Kapanadze, Executive director · ContactKapanadze.a@evex.ge · +995 599383322
    • Nino Maglakelidze · Principal investigator
  • Tbilisi Heart Center
    Tbilisi, 0186, Georgia
    Recruiting
    • Sergo Sakvarelidze, Executive director · Contactsergosakvarelidze@tbhc.ge · +995 577224454
    • Ketevan Tsanava · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04939116
Lead sponsor
Angion Biomedica Corp
Responsible party
Sponsor
First posted
Jun 25, 2021
Start date
Dec 24, 2021
Primary completion
Jul 31, 2023 (estimated)
Completion
Aug 31, 2023 (estimated)
Last update
Mar 23, 2022

Study contacts

Brandy Dupee
Contact
bdupee@angion.com
857-378-4302
John Neylan, MD
study director · Angion Biomedica

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: ANG3070

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