Study of Safety and Efficacy of ANG-3070 in Chronic Kidney Disease
NCT ID: NCT04939116
Last Updated: 2022-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2021-12-24
2023-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Safety and Efficacy of AZD5718 in Participants With Proteinuric Chronic Kidney Disease
NCT04492722
Safety and Efficacy of ANX-042 in Human Cardiorenal Syndrome
NCT03019653
Nefecon and Ambrisentan in IgA Nephropathy
NCT07030894
Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia
NCT07323095
Inaxaplin in Participants With Proteinuric APOL1 Mediated Kidney Disease With or Without Comorbidities
NCT06794996
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
200 mg QD
200 mg of ANG-3070 will be taken once daily for 12 weeks.
ANG-3070
Orally administered tyrosine kinase inhibitor capsule
400 mg QD
400 mg of ANG-3070 will be taken once daily for 12 weeks
ANG-3070
Orally administered tyrosine kinase inhibitor capsule
300 mg BID
300 mg of ANG-3070 will be taken twice a day for 12 weeks.
ANG-3070
Orally administered tyrosine kinase inhibitor capsule
Placebo
Placebo capsules will be taken once or twice daily for 12 weeks.
Placebo
Orally administered placebo capsule
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ANG-3070
Orally administered tyrosine kinase inhibitor capsule
Placebo
Orally administered placebo capsule
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Angion Biomedica Corp
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John Neylan, MD
Role: STUDY_DIRECTOR
Angion Biomedica
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Amicis Reserach Center
Northridge, California, United States
Amicis Reserach Center
Northridge, California, United States
Amicis Reserach Center
Vacaville, California, United States
South Florida Research Institute
Lauderdale Lakes, Florida, United States
Genesis Clinical Research LLC
Tampa, Florida, United States
Davita Clinical Research
Columbus, Georgia, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Davita Clinical Research
Edina, Minnesota, United States
Clinical Research Consultants, LLC.
Kansas City, Missouri, United States
Frenova Renal Research/Nephrology and Hypertension Specialists
St Louis, Missouri, United States
St. Louis Kidney Care
St Louis, Missouri, United States
New Jersey Kidney Care
Jersey City, New Jersey, United States
NYU Langone Nephrology Associates
Mineola, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Prolato Clinical Research Center
Houston, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Nepean Hospital
Kingswood, New South Wales, Australia
John Hunter Hospital
New Lambton, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Austin Health
Melbourne, Victoria, Australia
Western Hospital
Saint Albans, Victoria, Australia
JSC "Evex Hospitals"
Kutaisi, , Georgia
LtD Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, , Georgia
"Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies" LTD
Tbilisi, , Georgia
Ivane Bokeria Tbilisi Referral Hospital
Tbilisi, , Georgia
Tbilisi Heart Center
Tbilisi, , Georgia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Shannon Kokoszka, BN, RN, MN
Role: primary
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ANG3070-CKD-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.