Glomerular DiseasePhase 2NCT04939116
Study of Safety and Efficacy of ANG-3070 in Chronic Kidney Disease
A Phase 2 study testing ANG-3070 in people with Glomerular Disease and Proteinuria, run by Angion Biomedica Corp at 30 sites in 3 countries.
Trial summary
The major objective is to demonstrate the safety and efficacy of ANG-3070 in patients with primary glomerular disease and persistent proteinuria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glomerular Disease, Proteinuria
- What is being tested?
- ANG-3070
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 30 sitesin 3 countries
- Study dates
- 24 Dec 2021to 31 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
30 sites in 3 countries.
30 sites in 3 countries
United States19 sites, 19 recruiting
- Not yet recruiting
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Mohamed Atta, M.B.B.Ch., M.D., M.P.H., 319-384-9534, matta1@jhmi.edu
Mohamed Atta, M.B.B.Ch., M.D., M.P.H.
- Not yet recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Arun Rajasekaren, M.D., 205-934-1432, arajasekaran@uabmc.edu
Arun Rajasekaren, M.D.
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02108
Meghan Sise, M.D.,M.S., 617-643-0312, msise@partners.org
Meghan Sise, M.D.,M.S
- Not yet recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Theodore Steinman, M.D., 617-632-1070, tsteinma@bidmc.harvard.edu
Theodore Steinman, M.D.
- Not yet recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
Richard Solomon, M.D., B.A., 802-847-3734, richard.solomon@uvmhealth.org
Richard Solomon, M.D.,B.A.
- Recruiting
Davita Clinical Research
Columbus, Georgia, 31904
Vinayak Ramanath, M.D.,MBBS, 706-596-8222, Vramanath79@gmail.com
Vinayak Ramanath, M.D.,MBBS
- Recruiting
Davita Clinical Research
Edina, Minnesota, 55435
Johnathan Tollins, M.D., 612-508-9938, jtolins@comcast.net
Johnathan Tollins, M.D.
- Not yet recruiting
Prolato Clinical Research Center
Houston, Texas, 77054
Biruh Workeneh, M.D., 832-338-9118, btworkeneh@mdanderson.org
Biruh Workeneh, M.D.
- Recruiting
New Jersey Kidney Care
Jersey City, New Jersey, 07305
Deepika Jain, M.D., 917-920-0580, Deepika.Jain@fmc-na.com
Deepika Jain, M.D.
- Recruiting
Clinical Research Consultants, LLC.
Kansas City, Missouri, 64111
Ahmed Awad, D.O., 816-756-1222, awada@crckcmo.com
Ahmed Awad, D.O.
- Recruiting
South Florida Research Institute
Lauderdale Lakes, Florida, 33313
Edouard Martin, M.D.,MBBS, 706-596-8222, Vramanath79@gmail.com
Edouard Martin, M.D.,MBBS
- Not yet recruiting
NYU Langone Nephrology Associates
Mineola, New York, 11501
James Drakakis, D.O., 516-663-9041, james.drakakis@nyulangone.org
James Drakakis, D.O.
- Recruiting
Amicis Reserach Center
Northridge, California, 91324
Billy Hour, M.D., 818-924-4708, billy.hour@amicisresearch.com
Billy Hour, M.D.
- Recruiting
Amicis Reserach Center
Northridge, California, 91324
Anant Desai, M.D.,MBBS,GCE, 818-366-4632, a.desai@amicisresearch.com
Anant Desai, M.D.,MBBS,GCE
- Not yet recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Abdallah Geara, M.D., 215-662-2638, geara@pennmedicine.upenn.edu
Abdallah Geara, M.D.
- Recruiting
Frenova Renal Research/Nephrology and Hypertension Specialists
St Louis, Missouri, 63017
John Mellas, M.D., 217-372-4038, johnmellas56@gmail.com
John Mellas, M.D.
- Recruiting
St. Louis Kidney Care
St Louis, Missouri, 63136
Donovan Polack, M.D., 314-225-9937, donovanp@sbcglobal.net
Donovan Polack, M.D.
- Recruiting
Genesis Clinical Research LLC
Tampa, Florida, 33603
Jesus Navarro, M.D., 813-873-1016, drnpi@genesistrials.com
Jesus Navarro, M.D.
- Recruiting
Amicis Reserach Center
Vacaville, California, 95687
Piangwarin Phaosawasdi, M.D., 818-929-7774, p.phaosawasdi@amicisresearch.com
Piangwarin Phaosawasdi, M.D.
Australia6 sites, 6 recruiting
- Recruiting
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
Sharron H Ford, M.D., +61394194077, sharon.ford@svha.org.au
Sharon Ford
- Recruiting
Nepean Hospital
Kingswood, New South Wales, 2747
Bhadran Bose, MD, 02 4734 3814, bhadran.bose@health.nsw.gov.au
Bhadran Bose
- Recruiting
Austin Health
Melbourne, Victoria, 3102
Peter Mount, MBBS, B Med Sci, Ph.D.,, 03 9496 3059, peter.mount@austin.org.au
- Recruiting
John Hunter Hospital
New Lambton, New South Wales, 2305
Bruce MacKinnon, MB. ChB, M.D., FRCP, +61 2 49214321, Malcolm.Mackinnon@health.nsw.gov.au
- Recruiting
Western Hospital
Saint Albans, Victoria, 3021
Shannon Kokoszka, BN, RN, MN
+61 466 419 851, Shannon.Kokoszka@wh.org.au
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Diana Leary, BA, BN, 07 3176 6325, Diana.leary@health.qld.gov.au
Georgia5 sites, 5 recruiting
- Recruiting
JSC "Evex Hospitals"
Kutaisi, 4600
Anri Kapanadze, Executive director, +995 599383322, Kapanadze.a@evex.ge
Marina Dadunashvili
- Recruiting
LtD Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, 0112
Shmagi Tchiokadze, Executive director, +995 577771232, Sh.tchiokadze@hcore.ge
Avtandil Tataradze
- Recruiting
"Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies" LTD
Tbilisi, 0144
Giorgi Ingorokva, Executive director, +995 595105454, gocha.ingorokva@gmail.com
Irma Tchokhonelidze
- Recruiting
Ivane Bokeria Tbilisi Referral Hospital
Tbilisi, 0177
Anri Kapanadze, Executive director, +995 599383322, Kapanadze.a@evex.ge
Nino Maglakelidze
- Recruiting
Tbilisi Heart Center
Tbilisi, 0186
Sergo Sakvarelidze, Executive director, +995 577224454, sergosakvarelidze@tbhc.ge
Ketevan Tsanava
About this study
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
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.
- Conditions
- Glomerular Disease, Proteinuria
- Being tested
- ANG-3070, Placebo
- Keywords
- Glomerular Disease, Chronic Kidney Disease, Proteinuria
- Medical subject headings
- Proteinuria, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANG-3070Drug
Orally administered tyrosine kinase inhibitor capsule
PlaceboDrug
Orally administered placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| 200 mg QD | Experimental | 200 mg of ANG-3070 will be taken once daily for 12 weeks. Receives: Drug: ANG-3070 |
| 400 mg QD | Experimental | 400 mg of ANG-3070 will be taken once daily for 12 weeks Receives: Drug: ANG-3070 |
| 300 mg BID | Experimental | 300 mg of ANG-3070 will be taken twice a day for 12 weeks. Receives: Drug: ANG-3070 |
| Placebo | Placebo comparator | Placebo capsules will be taken once or twice daily for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in 24-hour urinary protein excretion at Week 12
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start24 Dec 2021
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glomerular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angion Biomedica Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Neylan, MD, Study director, Angion Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939116
- Sponsor's protocol ID
- ANG3070-CKD-201
- Status last verified
- Mar 2022
- First submitted
- 17 Jun 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04939116
- Acronym / sponsor ID
- ANG3070-CKD-201
- Conditions
- Glomerular Disease, Proteinuria
- Keywords
- Glomerular Disease, Chronic Kidney Disease, Proteinuria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Angion Biomedica CorpIndustry (pharma, biotech, devices)
- Study start
- 24 Dec 2021 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 200 mg QD | Experimental | Drug: ANG-3070200 mg of ANG-3070 will be taken once daily for 12 weeks. |
| 400 mg QD | Experimental | Drug: ANG-3070400 mg of ANG-3070 will be taken once daily for 12 weeks |
| 300 mg BID | Experimental | Drug: ANG-3070300 mg of ANG-3070 will be taken twice a day for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules will be taken once or twice daily for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANG-3070Orally administered tyrosine kinase inhibitor capsule | Drug | 200 mg QD, 300 mg BID, 400 mg QD |
| PlaceboOrally administered placebo capsule | Drug | Placebo |
Primary outcome
Percentage change in 24-hour urinary protein excretion at Week 12
Time frame: Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Neylan, MD study director
Angion Biomedica
30 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ANG-3070 in people with Glomerular Disease and Proteinuria, run by Angion Biomedica Corp at 30 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Australia, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brandy Dupee (857-378-4302, bdupee@angion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in 24-hour urinary protein excretion at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.