Clinical Trial

To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to compare the number of catheter-free days (CFD) and the rate and severity of any dialysis access-related infections between the ATEV and AVF groups over 12 months in patients with end-stage renal disease (ESRD) needing hemodialysis (HD). Participants will be stratified by location of the vascular access (forearm versus upper arm) and by type of AVF creation procedure planned by the surgeon at randomization (1-stage AVF versus 2-stage AVF). The comparator is an upper extremity arterio-venous fistula (AVF) for HD access surgically created per the institution's Standard of Care (SoC).
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2023-06-08; most recent amendment 2026-06-23.
Status change: Recruiting → Active, Not Recruiting 2026-06-23
Status change: Not Yet Recruiting → Recruiting 2023-09-12
Trial Details
NCT Number NCT05908084
Lead Sponsor Humacyte, Inc.
Collaborators: IQVIA Biotech
Conditions End Stage Renal Disease (ESRD)
Enrollment 121 participants
Start Date 2023-09-07
Primary Completion 2027-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-26