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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Glomerular Disease, Proteinuria

In brief

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

Key facts

Study ID

NCT04939116

Run by

Angion Biomedica Corp

People needed

100

Starts

2021-12-24

Expected to finish

2023-08-31

Last updated by the study team

2022-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• St Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia (enrolling)
• Austin Health — Melbourne, Victoria, Australia (enrolling)
• Western Hospital — Saint Albans, Victoria, Australia (enrolling)
• JSC "Evex Hospitals" — Kutaisi, Georgia (enrolling)
• LtD Israeli-Georgian Medical Research Clinic Helsicore — Tbilisi, Georgia (enrolling)
• "Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies" LTD — Tbilisi, Georgia (enrolling)
• Ivane Bokeria Tbilisi Referral Hospital — Tbilisi, Georgia (enrolling)
• Tbilisi Heart Center — Tbilisi, Georgia (enrolling)
• Amicis Reserach Center — Northridge, California, United States (enrolling)
• Amicis Reserach Center — Vacaville, California, United States (enrolling)
• Davita Clinical Research — Edina, Minnesota, United States (enrolling)
• Clinical Research Consultants, LLC. — Kansas City, Missouri, United States (enrolling)
• Frenova Renal Research/Nephrology and Hypertension Specialists — St Louis, Missouri, United States (enrolling)
• St. Louis Kidney Care — St Louis, Missouri, United States (enrolling)
• New Jersey Kidney Care — Jersey City, New Jersey, United States (enrolling)
• South Florida Research Institute — Lauderdale Lakes, Florida, United States (enrolling)
• Genesis Clinical Research LLC — Tampa, Florida, United States (enrolling)
• Davita Clinical Research — Columbus, Georgia, United States (enrolling)
• Amicis Reserach Center — Northridge, California, United States (enrolling)
• Nepean Hospital — Kingswood, New South Wales, Australia (enrolling)
• John Hunter Hospital — New Lambton, New South Wales, Australia (enrolling)
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (enrolling)
• NYU Langone Nephrology Associates — Mineola, New York, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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