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

End Stage Renal Disease Clinical Trial

Official title: 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 Active, not recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• End Stage Renal Disease
• Fistula
• Hemodialysis
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Failure
• Vascular Access

• NCT number: NCT03183245
• Study type: Interventional
• Source: Humacyte, Inc.
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 29, 2017
• Completion date: September 2029