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

Sponsor
Angion Biomedica Corp (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04939116
Collaborator
(none)
100
Enrollment
30
Locations
4
Arms
20.2
Anticipated Duration (Months)
3.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
Anticipated 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 :
Dec 24, 2021
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

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

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  1. Hemoglobin A1C > 8.5%.

  2. Known predisposition to bleeding and/or thrombosis

  3. Type I diabetes mellitus.

  4. 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

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35294
2 Amicis Reserach Center Northridge California United States 91324
3 Amicis Reserach Center Northridge California United States 91324
4 Amicis Reserach Center Vacaville California United States 95687
5 South Florida Research Institute Lauderdale Lakes Florida United States 33313
6 Genesis Clinical Research LLC Tampa Florida United States 33603
7 Davita Clinical Research Columbus Georgia United States 31904
8 The Johns Hopkins Hospital Baltimore Maryland United States 21287
9 Massachusetts General Hospital Boston Massachusetts United States 02108
10 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
11 Davita Clinical Research Edina Minnesota United States 55435
12 Clinical Research Consultants, LLC. Kansas City Missouri United States 64111
13 Frenova Renal Research/Nephrology and Hypertension Specialists Saint Louis Missouri United States 63017
14 St. Louis Kidney Care Saint Louis Missouri United States 63136
15 New Jersey Kidney Care Jersey City New Jersey United States 07305
16 NYU Langone Nephrology Associates Mineola New York United States 11501
17 University of Pennsylvania Philadelphia Pennsylvania United States 19104
18 Prolato Clinical Research Center Houston Texas United States 77054
19 University of Vermont Medical Center Burlington Vermont United States 05401
20 Nepean Hospital Kingswood New South Wales Australia 2747
21 John Hunter Hospital New Lambton New South Wales Australia 2305
22 Princess Alexandra Hospital Woolloongabba Queensland Australia 4102
23 St Vincent's Hospital Melbourne Fitzroy Victoria Australia 3065
24 Austin Health Melbourne Victoria Australia 3102
25 Western Hospital Saint Albans Victoria Australia 3021
26 JSC "Evex Hospitals" Kutaisi Georgia 4600
27 LtD Israeli-Georgian Medical Research Clinic Helsicore Tbilisi Georgia 0112
28 "Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies" LTD Tbilisi Georgia 0144
29 Ivane Bokeria Tbilisi Referral Hospital Tbilisi Georgia 0177
30 Tbilisi Heart Center Tbilisi Georgia 0186

Sponsors and Collaborators

  • Angion Biomedica Corp

Investigators

  • Study Director: John Neylan, MD, Angion Biomedica

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Angion Biomedica Corp
ClinicalTrials.gov Identifier:
NCT04939116
Other Study ID Numbers:
  • ANG3070-CKD-201
First Posted:
Jun 25, 2021
Last Update Posted:
Mar 23, 2022
Last Verified:
Mar 1, 2022
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:
Proteinuria

Study Results

No Results Posted as of Mar 23, 2022