NCT03183245

Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis

A Phase 3 Study to Compare the Efficacy and Safety of Humacyte's Human Acellular Vessel With That of an Autologous Arteriovenous Fistula in Subjects With End Stage Renal Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Humacyte, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to compare the Human Acellular Vessel (HAV) with arteriovenous fistula (AVF) when used for hemodialysis access

Detailed description

This is a Phase 3, prospective, multicenter, open-label, randomized, two-arm, comparative study. Subjects who sign informed consent will undergo study-specific screening assessments within 45 days from the day of informed consent. Eligible study subjects will be randomized to receive either an HAV or AVF. The randomization will be stratified by upper arm or forearm placement based on the investigator's determination of where the study access (SA) should be located. Subjects will be followed to 24 months post SA creation at routine study visits regardless of patency status. After 24 months, AVF subjects with a patent SA will be followed (while the SA remains patent) for up to 5 years (60 months) post SA creation at routine study visits. After 24 months, HAV subjects will be followed (regardless of SA patency) for 5 years (60 months) post SA creation at routine study visits.

Conditions

• Renal Failure
• End Stage Renal Disease
• Hemodialysis
• Vascular Access

Interventions

Type	Name	Description
BIOLOGICAL	Human Acellular Vessel (HAV)	Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
PROCEDURE	Arteriovenous fistula (AVF)	Surgical creation of an autologous arteriovenous fistula and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
OTHER	Hemodialysis	Procedure that filters a person's blood when their kidneys are no longer functioning properly

Timeline

• Start date: 2017-09-29
• Primary completion: 2024-04-22
• Completion: 2025-06-19
• First posted: 2017-06-12
• Last updated: 2025-11-20

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study