NCT02644941

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

An Assessment of Humacyte's Human Acellular Vessel in Patients Needing Renal Replacement Therapy: A Comparison With ePTFE Grafts as Conduits for Hemodialysis (HUMANITY)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 355 (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 ePTFE grafts when used for hemodialysis access.

Detailed description

This is a Phase 3, prospective, multicenter, multinational, open-label, randomized, two-arm, comparative study. Subjects who sign informed consent would undergo study-specific screening assessments within 35 days from the day of informed consent. Participants who consented were randomized to the HAV treatment arm of one of the two commercially available comparators.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Human Acellular Vessel (HAV)	HAV-tissue-engineered vascular conduit (6mm diameter)
DEVICE	ePTFE graft	One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)

Timeline

• Start date: 2016-05-24
• Primary completion: 2019-05-01
• Completion: 2023-09-01
• First posted: 2016-01-01
• Last updated: 2025-03-30
• Results posted: 2025-03-30

Locations

38 sites across 6 countries: United States, Germany, Israel, Poland, Portugal, United Kingdom