A Phase 3 Randomized Study to Compare the Efficacy and Safety of the Humacyte Acellular Tissue Engineered Vessel (ATEV) With That of an Autogenous Arteriovenous Fistula (AVF) in Female Patients With End-Stage Renal Disease Requiring Hemodialysis

Humacyte, Inc.

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).

Description

This is a prospective, multicenter, randomized, two-arm, comparative Phase 3 study of female patients with ESRD, who are receiving clinically successful hemodialysis (HD) via a central venous dialysis catheter (DC). Approximately 150 female patients will be randomized 1:1 to either the ATEV or the AVF treatment arm. Patients 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). All patients will be followed through Month 12 regardless of SA patency status…

Eligibility

Age range: 18+ years
Sex: Female
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Female patients with ESRD, currently receiving hemodialysis via dialysis catheter and who are candidates for the creation of an AVF (see Inclusion Criterion #4 below) or implantation of an ATEV for HD access. 2. Patients who plan to undergo HD at a dialysis unit of a participating dialysis provider for at least 12 months after SA creation. 3. Patients aged ≥ 18 years at Screening. 4. Suitable anatomy for creation of a forearm or upper arm AVF and for implantation of straight, curved, or looped ATEV in either the forearm or upper arm. NOTE: Suitable anatomy will be d…

Interventions

Biological
Acellular Tissue Engineered Vessel (ATEV)
ATEV implantation
Other
AVF
AVF creation procedure

Locations (32)

Honor Health Scottsdale Shea Medical Center
Scottsdale, Arizona
El Centro Regional Medical Center
El Centro, California
Jacob's Medical Center at UC San Diego Health
La Jolla, California
Denver Health and Hospital Authority
Denver, Colorado
Yale New Haven Hospital
New Haven, Connecticut
Access Research Institute
Brooksville, Florida