Glomerular Disease, Proteinuria
Conditions
Keywords
Glomerular Disease, Chronic Kidney Disease, Proteinuria
Brief summary
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.
Interventions
DRUGANG-3070
Orally administered tyrosine kinase inhibitor capsule
DRUGPlacebo
Orally administered placebo capsule
Sponsors
Angion Biomedica Corp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in 24-hour urinary protein excretion at Week 12 | Week 12 |
Countries
Australia, Georgia, United States
Contacts
Primary ContactBrandy Dupee
Outcome results
None listed