Abstract: PO1644
Safety and Efficacy of ANG-3070 in Patients with Primary Proteinuric Kidney Disease: A Phase 2 Study Design
Session Information
- Glomerular Diseases: Treatment and Outcomes
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1203 Glomerular Diseases: Clinical, Outcomes, and Trials
Authors
- Radhakrishnan, Jai, Columbia University Irving Medical Center, New York, New York, United States
- Aslam, Shakil, Angion Biomedica Corp, Uniondale, New York, United States
- Neylan, John F., Angion Biomedica Corp, Uniondale, New York, United States
- Rizk, Dana, University of Alabama at Birmingham, Birmingham, Alabama, United States
- Trachtman, Howard, NYU Grossman School of Medicine, New York, New York, United States
Background
Primary proteinuric kidney diseases (PPKDs) are among the leading causes of End-Stage Kidney Disease (ESKD). Receptor tyrosine kinases like PDGFR, DDR1, DDR2 are thought to play a role in the progression of PPKDs to ESKD. ANG-3070, a selective oral tyrosine kinase inhibitor, has demonstrated beneficial effects in chronic kidney disease animal models.
Objective: Describe the design of a proof-of-concept study of ANG-3070 in the treatment of PPKD patients with persistent proteinuria while on standard of care (SOC).
Methods
A 12-week, randomized, double-blind, placebo-controlled study enrolling 100 patients with biopsy-proven PPKD and persistent proteinuria, ≥ 1 g/day, while on the SOC including maximum tolerated RAAS inhibitors. Patients will be randomized 1:1:1:1 to 200 mg or 400 mg once-daily or 300 mg twice-daily of ANG-3070 or placebo (Fig.1).
Results
The primary endpoint is the percentage change in 24-hr urinary protein at Week 12. Key secondary endpoints evaluated at week 12 include percentage change in 24-hr urinary albumin, number of patients with complete remission in proteinuria (24-hr urinary protein < 300 mg), number of patients with partial remissions in proteinuria (24-hr urinary protein reduction of ≥ 50% from the baseline and a 24-hr urinary protein < 3.5 g/day if the baseline 24-hr urinary protein > 3.5 g), number of patients with ≥ 50% reduction in 24-hr urinary protein from the baseline, and number of patients with ≥ 50% reduction in 24-hr urinary albumin from baseline. An independent data monitoring committee will review safety throughout the study.
Conclusion
This Phase 2 study will provide data about the safety and efficacy of ANG-3070 in PPKD patients that will inform the design of a Phase 3 study.
Funding
- Commercial Support –