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

Inclusion Criteria:

1. Subjects with end-stage renal disease (ESRD), receiving HD via DC and are suitablefor the creation of an AVF or implantation of AVG for HD access.

2. Subjects who plan to undergo HD at a dialysis unit of a participating dialysisprovider for at least the first 6 months after SA creation.

3. Subjects aged at least 18 years at Screening.

4. Suitable anatomy for creation of a forearm or upper arm AVF and for implantation ofstraight or looped HAV in either the forearm or upper arm.

5. Hemoglobin ≥8 g/dL and platelet count ≥100,000 /mm3.

6. International Normalized Ratio (INR) ≤ 1.5.

7. Female subjects must be either:

8. Of non-childbearing potential, which is defined as post-menopausal (at least 1year without menses prior to Screening) or documented surgically sterile orpost hysterectomy (at least 1 month prior to Screening).

9. Or, of childbearing potential, in which case: i. Must have a negative urine or serum pregnancy test at Screening, and ii. Mustagree to use at least one form of the following birth control methods for theduration of the study:

• Established use of oral, injectable or implanted hormonal methods ofcontraception.

• Placement of an intrauterine device or intrauterine system.

• Barrier methods of contraception: condom or occlusive cap (diaphragm orcervical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository.

8. Subject, or legal representative, able to communicate effectively with investigativestaff, competent and willing to give written informed consent, and able to complywith entire study procedures including all scheduled follow-up visits.

9. Life expectancy of at least 2 years.

Exclusion Criteria:

1. Subjects who are optimal candidates for radiocephalic AVF as indicated by meetingALL of the following criteria:

2. No previous failed AVF.

3. Cephalic vein diameter on ultrasound of more than 3.5mm.

4. Radial artery diameter on ultrasound of more than 3mm.

5. Vein depth of less than 0.5cm from the skin.

6. Normal Allen's test indicating that ulnar artery flow to the hand issufficient.

7. No calcification in the wall of the distal radial artery.

8. Sufficient length of the proposed fistula outflow vein to provide an adequate (at least 6 cm) cannulation segment.

9. No evidence of iatrogenic injury to target artery or vein.

10. Uncontrolled diabetes; a. HbA1c >10% (at Screening).

11. History or evidence of severe peripheral arterial disease in the extremity selectedfor implant.

12. Known or suspected central vein stenosis or obstruction on the side of planned SAcreation, unless corrected prior to randomization.

13. Planned AVF creation that requires more than one stage to complete. (e.g. basilicvein transposition AVF performed in 2 stages).

14. Planned AVF creation by means other than suture or vascular anastomotic clips (e.g.endovascular surgery or other anastomotic creation devices).

15. Treatment with any investigational drug or device within 60 days prior to studyentry (Day 0) or ongoing participation in a clinical trial of an investigationalproduct.

16. Cancer that is actively being treated with a cytotoxic agent.

17. Documented hyper-coagulable state.

18. Bleeding diathesis.

19. Active clinically significant immune-mediated disease, not controlled by maintenanceimmunosuppression.

20. Low dose glucocorticoid therapy (e.g. 5-10mg prednisone [Deltason]) isacceptable.

21. High dose glucocorticoid therapy for treatment of autoimmune flare, or otherinflammatory diseases is excluded.

22. Patients using glucocorticoids for immunosuppression post-transplant to preventagainst transplanted allograft rejection in the period post allograft failureare excluded.

23. The following examples of immunosuppressive agents (or the like) areexclusionary for enrollment in this clinical trial:

• tacrolimus or FK506 [Prograf]
• mycophenolate mofetil [Cellcept],
• cyclosporine [Sandimmune or Gengraf]
• sirolimus [Rapamune] (this only includes systemically administered, drugeluting stents are acceptable)

12. Anticipated renal transplant within 6 months.

13. History of heparin-induced thrombocytopenia.

14. Venous outflow from SA cannot be located more centrally than the venous outflow ofany previous failed access in that extremity.

15. Active local or systemic infection (white blood cells [WBC] > 15,000 cells/mm3 atScreening). If the infection resolves, the subject must be at least one week postresolution of that infection before SA creation.

16. Known serious allergy or intolerance to aspirin and alternative antiplatelettherapy.

17. Pregnant women, or women intending to become pregnant during the course of thetrial.

18. Any other condition which in the judgment of the investigator would precludeadequate evaluation of the safety and efficacy of the SA.

19. Previous enrollment in this study or any other study with HAV.

20. Employees of Humacyte and employees or relatives of an investigator.