CompletedPhase 3

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

United States242 participantsStarted 2017-09-29

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subjects with end-stage renal disease (ESRD), receiving HD via DC and are suitable for the creation of an AVF or implantation of AVG for HD access.
✓. Subjects who plan to undergo HD at a dialysis unit of a participating dialysis provider for at least the first 6 months after SA creation.
✓. Subjects aged at least 18 years at Screening.
✓. Suitable anatomy for creation of a forearm or upper arm AVF and for implantation of straight or looped HAV in either the forearm or upper arm.
✓. Hemoglobin ≥8 g/dL and platelet count ≥100,000 /mm3.
✓. International Normalized Ratio (INR) ≤ 1.5.
✓. Female subjects must be either:
✓. Of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile or post hysterectomy (at least 1 month prior to Screening).

✕. Subjects who are optimal candidates for radiocephalic AVF as indicated by meeting ALL of the following criteria:
✕. No previous failed AVF.
✕. Cephalic vein diameter on ultrasound of more than 3.5mm.
✕. Radial artery diameter on ultrasound of more than 3mm.
✕. Vein depth of less than 0.5cm from the skin.
✕. Normal Allen's test indicating that ulnar artery flow to the hand is sufficient.
✕. No calcification in the wall of the distal radial artery.
✕. Sufficient length of the proposed fistula outflow vein to provide an adequate (at least 6 cm) cannulation segment.

Proportion of subjects with functional patency at 6 months post study access (SA) creation

Timeframe: 6 months post SA creation

Proportion of subjects with secondary patency of SA at 12 months post SA creation.

Timeframe: 12 months post SA creation

NCT IDNCT03183245

SponsorHumacyte, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-22

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subjects with end-stage renal disease (ESRD), receiving HD via DC and are suitable for the creation of an AVF or implantation of AVG for HD access.
✓. Subjects who plan to undergo HD at a dialysis unit of a participating dialysis provider for at least the first 6 months after SA creation.
✓. Subjects aged at least 18 years at Screening.
✓. Suitable anatomy for creation of a forearm or upper arm AVF and for implantation of straight or looped HAV in either the forearm or upper arm.
✓. Hemoglobin ≥8 g/dL and platelet count ≥100,000 /mm3.
✓. International Normalized Ratio (INR) ≤ 1.5.
✓. Female subjects must be either:
✓. Of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile or post hysterectomy (at least 1 month prior to Screening).

✕. Subjects who are optimal candidates for radiocephalic AVF as indicated by meeting ALL of the following criteria:
✕. No previous failed AVF.
✕. Cephalic vein diameter on ultrasound of more than 3.5mm.
✕. Radial artery diameter on ultrasound of more than 3mm.
✕. Vein depth of less than 0.5cm from the skin.
✕. Normal Allen's test indicating that ulnar artery flow to the hand is sufficient.
✕. No calcification in the wall of the distal radial artery.
✕. Sufficient length of the proposed fistula outflow vein to provide an adequate (at least 6 cm) cannulation segment.