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
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with arteriovenous fistula (AVF) when used for hemodialysis access
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.
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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;
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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;
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Subjects aged at least 18 years at Screening;
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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;
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Hemoglobin >8 g/dL and platelet count >100,000 /mm3;
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International Normalized Ratio (INR) <1.5;
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Please contact study team for additional inclusion/exclusion criteria;
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Subjects who are optimal candidates for radiocephalic AVF as indicated by meeting ALL of the following criteria:
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* No previous failed AVF.
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* Cephalic vein diameter on ultrasound of more than 3.5mm.
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* Radial artery diameter on ultrasound of more than 3mm.
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* Vein depth of less than 0.5cm from the skin.
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* Normal Allen's test indicating that ulnar artery flow to the hand is sufficient.
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* No calcification in the wall of the distal radial artery.
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* Sufficient length of the proposed fistula outflow vein to provide an adequate (at least 6 cm) cannulation segment.
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* No evidence of iatrogenic injury to target artery or vein;
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Uncontrolled diabetes:
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* HbA1c >10% (at Screening);
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History or evidence of severe peripheral arterial disease in the extremity selected for implant;
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Known or suspected central vein stenosis or obstruction on the side of planned SA creation, unless corrected prior to randomization;
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Please contact study team for additional inclusion/exclusion criteria;
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Pathological Conditions, Anatomical
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Renal Insufficiency, Chronic
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