Abstract: TH-OR113
Randomized Controlled Trial of an Acellular Tissue Engineered Vessel vs. Arteriovenous Fistula for Hemodialysis Access in Female Patients with ESKD: A Phase 3 CLN-PRO-V012 Interim Analysis
Session Information
- Late-Breaking Research Orals: Dialysis and Transplantation
October 22, 2026 | Location: Four Seasons Ballroom 2, Convention Center
Abstract Time: 04:42 PM - 04:54 PM
Category: Dialysis
- 803 Dialysis: Vascular Access
Authors
- Hussain, Mohamad Anas, Mass General Brigham Inc, Boston, Massachusetts, United States
- Roy-Chaudhury, Prabir, The University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, United States
- Bou-Ghannam, Sophia, Humacyte Global Inc, Durham, North Carolina, United States
- Niklason, Laura E., Humacyte Global Inc, Durham, North Carolina, United States
- Parikh, Shamik J., Humacyte Global Inc, Durham, North Carolina, United States
Background
Arteriovenous fistulas (AVF) are preferred for hemodialysis (HD) but are limited by delayed or failed maturation, prolonging central venous catheter (CVC) use. Women experience lower AVF maturation and greater CVC dependence than men, contributing to morbidity. Acellular tissue engineered vessels (ATEV) may provide earlier, more reliable access in this high-risk population.
Methods
V012 is a prospective, multicenter, randomized Phase 3 trial in females with end-stage kidney disease (ESKD) receiving HD via catheter and eligible for AVF creation. Patients were randomized 1:1 to ATEV or AVF. The primary endpoint was catheter-free days (CFD) through 12 months. A prespecified superiority analysis was performed after 80 patients completed 12-month follow-up.
Results
Each group included 40 patients. ATEV met the primary endpoint, increasing mean 12-month CFD versus AVF (220 vs 129 days; difference, 91; 95% CI, 40–142; P<0.001), demonstrating superiority versus AVF. At 6 months, ATEV provided 52 additional CFD (P<0.0001). Functional patency over 12 months was greater with ATEV (250 vs 152 days; P<0.001), and mean time to maturation was substantially shorter (1.7 vs 5.3 months, Fig1). ATEV secondary patency was higher at 6 months (88% vs 65%; P=0.02) and numerically higher at 12 months (78% vs 63%; P=0.16). More dialysis access-related (including CVC) infections occurred with AVF (15% vs 5.1% ATEV); no study access-related infections occurred in either group. True/pseudoaneurysm and steal syndrome were infrequent, with no study access ruptures observed. Thrombosis and stenosis events were more frequent with ATEV (20 and 43 vs 8 and 36 AVF, respectively), though usage-adjusted stenosis rates were lower with ATEV (162 vs 229 AVF per 100 patient-years).
Conclusion
In females with ESKD, ATEV significantly increased CFD versus AVF, enabling earlier, more reliable functional access with fewer dialysis access infections and no ATEV infections. This first randomized evaluation of a vascular access conduit in this vulnerable population supports ATEV as a potential first-line option for females at increased risk of AVF maturation failure.
Funding
- Commercial Support – Humacyte