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

End Stage Renal Disease (ESRD) Clinical Trial

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

Clinical Trial 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 HAV 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).

Clinical Trial 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 HAV 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). Patients who have a patent SA at Month 12 will then be followed in the Long-Term Extension study for an additional 12 months with evaluation of exploratory long-term endpoints. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05908084
Study type Interventional
Source Humacyte, Inc.
Contact Jordanna Foster
Phone 9193139633
Email jfoster@humacyte.com
Status Recruiting
Phase Phase 3
Start date September 7, 2023
Completion date October 2027
View Details
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