Recruiting
Phase 2

ANG-3070

Sponsor:

Angion Biomedica Corp

Code:

NCT04939116

Conditions

Glomerular Disease

Proteinuria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ANG-3070

Placebo

Study Details

Brief summary:

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

Conditions

Glomerular Disease

Proteinuria

Study ID

NCT04939116

Start date

Dec 24, 2021

Status verified date

Mar, 2022

Completion date

Aug 31, 2023

Anticipated

Primary completion date

Jul 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 200 mg QD

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

experimental: 400 mg QD

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

experimental: 300 mg BID

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

placebo comparator: Placebo

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

Interventions

ANG-3070

Orally administered tyrosine kinase inhibitor capsule

Placebo

Orally administered placebo capsule

Primary outcome measure

  • Percentage change in 24-hour urinary protein excretion at Week 12 [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Locations

Amicis Reserach Center

Recruiting

Northridge, California, United States, 91324

Contacts

Principal Investigator:

Billy Hour, M.D.

Amicis Reserach Center

Recruiting

Northridge, California, United States, 91324

Contacts

Anant Desai, M.D.,MBBS,GCE

818-366-4632a.desai@amicisresearch.com

Principal Investigator:

Anant Desai, M.D.,MBBS,GCE

Amicis Reserach Center

Recruiting

Vacaville, California, United States, 95687

Contacts

Principal Investigator:

Piangwarin Phaosawasdi, M.D.

South Florida Research Institute

Recruiting

Lauderdale Lakes, Florida, United States, 33313

Contacts

Edouard Martin, M.D.,MBBS

706-596-8222Vramanath79@gmail.com

Principal Investigator:

Edouard Martin, M.D.,MBBS

Genesis Clinical Research LLC

Recruiting

Tampa, Florida, United States, 33603

Contacts

Principal Investigator:

Jesus Navarro, M.D.

Davita Clinical Research

Recruiting

Columbus, Georgia, United States, 31904

Contacts

Vinayak Ramanath, M.D.,MBBS

706-596-8222Vramanath79@gmail.com

Principal Investigator:

Vinayak Ramanath, M.D.,MBBS

Davita Clinical Research

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Johnathan Tollins, M.D.

612-508-9938jtolins@comcast.net

Principal Investigator:

Johnathan Tollins, M.D.

Clinical Research Consultants, LLC.

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Principal Investigator:

Ahmed Awad, D.O.

Frenova Renal Research/Nephrology and Hypertension Specialists

Recruiting

Saint Louis, Missouri, United States, 63017

Contacts

Principal Investigator:

John Mellas, M.D.

St. Louis Kidney Care

Recruiting

Saint Louis, Missouri, United States, 63136

Contacts

Principal Investigator:

Donovan Polack, M.D.

New Jersey Kidney Care

Recruiting

Jersey City, New Jersey, United States, 07305

Contacts

Principal Investigator:

Deepika Jain, M.D.

More Information

Sponsor

Angion Biomedica Corp

Last update posted

Mar 23, 2022

Last verified

Mar, 2022

Keywords

  • Glomerular Disease
  • Chronic Kidney Disease
  • Proteinuria

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Angion Biomedica Corp on 2022-03-23.