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

Phase 2

• Conditions: Proteinuria; Glomerular Disease
• Interventions: Drug: ANG-3070; Drug: Placebo

• Registration Number: NCT04939116
• Lead Sponsor: Angion Biomedica Corp

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.

Study Timeline

• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-25
• Study Start: 2021-12-24
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-03-23
• Primary Completion: 2023-07-31
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
400 mg QD	ANG-3070	400 mg of ANG-3070 will be taken once daily for 12 weeks
200 mg QD	ANG-3070	200 mg of ANG-3070 will be taken once daily for 12 weeks.
300 mg BID	ANG-3070	300 mg of ANG-3070 will be taken twice a day for 12 weeks.
Placebo	Placebo	Placebo capsules will be taken once or twice daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage change in 24-hour urinary protein excretion at Week 12	Week 12

Trial Locations

Locations (27)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, 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; 🇺🇸 Edina, Minnesota, 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

Clinical Research Consultants, LLC.; 🇺🇸 Kansas City, Missouri, United States

Frenova Renal Research/Nephrology and Hypertension Specialists; 🇺🇸 Saint Louis, Missouri, United States

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