Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around

Description

Summary

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

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

Details

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.

Keywords

Renal Failure, End Stage Renal Disease, Hemodialysis, Vascular Access, Kidney Diseases, Chronic Kidney Failure, Fistula, Human Acellular Vessel (HAV), Arteriovenous fistula (AVF)

Eligibility

Locations

  • University of California San Diego, Jacobs Medical Center
    La Jolla California 92103 United States
  • University of CA, San Diego - LaJolla VA Hospital
    La Jolla California 92161 United States
  • Balboa Nephrology
    San Diego California 92123 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Humacyte, Inc.
ID
NCT03183245
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated