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

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ClinicalTrials.gov Identifier: NCT04939116
Recruitment Status : Recruiting
First Posted : June 25, 2021
Last Update Posted : March 23, 2022
Sponsor:
Information provided by (Responsible Party):
Angion Biomedica Corp

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

Condition or disease Intervention/treatment Phase
Glomerular Disease Proteinuria Drug: ANG-3070 Drug: Placebo Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 24, 2021
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 200 mg QD
200 mg of ANG-3070 will be taken once daily for 12 weeks.
 Drug: ANG-3070
Orally administered tyrosine kinase inhibitor capsule
Experimental: 400 mg QD
400 mg of ANG-3070 will be taken once daily for 12 weeks
 Drug: ANG-3070
Orally administered tyrosine kinase inhibitor capsule
Experimental: 300 mg BID
300 mg of ANG-3070 will be taken twice a day for 12 weeks.
 Drug: ANG-3070
Orally administered tyrosine kinase inhibitor capsule
Placebo Comparator: Placebo
Placebo capsules will be taken once or twice daily for 12 weeks.
 Drug: Placebo
Orally administered placebo capsule


Outcome Measures
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Primary Outcome Measures :
  1. Percentage change in 24-hour urinary protein excretion at Week 12 [ Time Frame: Week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04939116


Contacts
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Contact: Brandy Dupee 857-378-4302 bdupee@angion.com

Locations
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Sponsors and Collaborators
Angion Biomedica Corp
Investigators
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Study Director: John Neylan, MD Angion Biomedica
More Information
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Responsible Party: Angion Biomedica Corp
ClinicalTrials.gov Identifier: NCT04939116    
Other Study ID Numbers: ANG3070-CKD-201
First Posted: June 25, 2021    Key Record Dates
Last Update Posted: March 23, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Angion Biomedica Corp:
Glomerular Disease
Chronic Kidney Disease
Proteinuria
Additional relevant MeSH terms:
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Proteinuria
Urologic Diseases
Urination Disorders
Urological Manifestations