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

Recruiting in Palo Alto (17 mi)

+28 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Angion Biomedica Corp

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing ANG-3070, a new drug, in people with a kidney disease that causes protein loss in urine. The goal is to see if it can improve kidney function and reduce the amount of protein lost.

Research Team

John Neylan, MD

Principal Investigator

Angion Biomedica

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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%

Treatment Details

Interventions

• ANG-3070 (Other)
• Placebo (Other)

Participant Groups

Group I: 400 mg QD Experimental Treatment 1 Intervention

400 mg of ANG-3070 will be taken once daily for 12 weeks

Group II: 300 mg BID Experimental Treatment 1 Intervention

300 mg of ANG-3070 will be taken twice a day for 12 weeks.

Group III: 200 mg QD Experimental Treatment 1 Intervention

200 mg of ANG-3070 will be taken once daily for 12 weeks.

Group IV: Placebo Placebo Group 1 Intervention

Placebo capsules will be taken once or twice daily for 12 weeks.

Who Is Running the Clinical Trial?

Angion Biomedica Corp

Lead Sponsor

Trials

12

Recruited

960+