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

  • STATUS
    Recruiting
  • End date
    Sep 11, 2024
  • participants needed
    240
  • sponsor
    Humacyte, Inc.
Updated on 11 July 2021
Investigator
Karthi Natarajan, MPH
Primary Contact
Brigham and Women's Hospital (5.2 mi away) Contact
+35 other location
platelet count
immunosuppressive agents
renal failure
nephropathy
dialysis
chronic renal failure

Summary

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

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.

Details
Condition Renal Failure, Chronic renal failure, Hemodialysis, Stage 5 Chronic Kidney Disease, Vascular Access, Kidney Failure (Pediatric), Chronic Kidney Disease Stage 5, CKD Stage 5, Kidney Failure, renal insufficiency, end stage renal disease, chronic renal disease, end-stage renal disease, esrd, end-stage renal failure, end stage kidney disease, end stage renal failure
Treatment Human Acellular Vessel (HAV), Arteriovenous fistula (AVF)
Clinical Study IdentifierNCT03183245
SponsorHumacyte, Inc.
Last Modified on11 July 2021

Eligibility

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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