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)

The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.

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.

Inclusion Criteria:

• Subjects with ESRD who need placement of an AV graft in the arm.

• Either on hemodialysis or expected to start hemodialysis within 12 weeks of study conduit implantation.

• Suitable anatomy for implantation of straight or looped conduits in either the forearm or upper arm (not crossing the elbow).

• Hemoglobin ≥8 g/dL and platelet count ≥100,000 cells/mm3 prior to Day 0 (within 35 days).

• Other hematological and biochemical parameters within a range consistent with ESRD prior to Day 0 (within 35 days).

• Adequate liver function prior to Day 0 (within 35 days).

• Female subjects must be either:

  • Of non-childbearing potential Or
  • Must agree to use at least one form of birth control methods for the duration of the study.

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

• Life expectancy of at least 1 year.

Exclusion Criteria:

• History or evidence of severe peripheral vascular disease in the intended arm for implantation.
• Known or suspected central vein stenosis or conduit occlusion on the ipsilateral side of planned implantation, unless the stenosis is corrected prior to study conduit implantation.
• Treatment with any investigational drug or device within 60 days prior to study entry (Day 0).
• Cancer that is actively being treated with a cytotoxic agent.
• Documented hyper-coagulable state.
• Bleeding diathesis.
• Active clinically significant immune-mediated disease, not controlled by maintenance immunosuppression.
• High dose glucocorticoid therapy for treatment of autoimmune flare, or other inflammatory diseases is excluded.
• Patients using glucocorticoids for immunosuppression post-transplant to prevent against transplanted allograft rejection in the period post allograft failure are excluded.
• The following examples of immunosuppressive agents (or the like) are exclusionary for enrollment in this clinical trial:
• tacrolimus or FK506 [Prograf]
• mycophenolate mofetil [Cellcept],
• cyclosporine [Sandimmune or Gengraf] i-Sirolimus administered systemically (Sirolimus in drug eluting stents is NOT an exclusion)
• Anticipated renal transplant within 6 months.
• Venous outflow from study conduit cannot be placed more centrally than the venous outflow of any previous failed access in that extremity.
• Active local or systemic infection (white blood cells [WBC] > 15,000 cells/mm3 at Screening). If the infection resolves, the subject must be at least one week post resolution of that infection before implantation.
• Known serious allergy to planned antiplatelet agent.
• Pregnant women, or women intending to become pregnant during the course of the trial.
• Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the study conduit.
• Previous enrollment in this study or any other study with the HAV.
• Employees of Humacyte and employees or relatives of the investigator.