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

Completed · Phase 3

Conditions studied: Renal Failure, End Stage Renal Disease, Hemodialysis, Vascular Access

In brief

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

Key facts

Study ID

NCT02644941

Run by

Humacyte, Inc.

People needed

355

Starts

2016-05-24

Expected to finish

2023-09-01

Last updated by the study team

2025-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Kidney Disease and Hypertension Center (AKDHC) — Phoenix, Arizona, United States
• Carondelet St. Mary's Hospital — Tucson, Arizona, United States
• Ladenheim Dialysis Access Center — Fresno, California, United States
• General Surgery and Vascular Access — Fresno, California, United States
• University of California Irvine (UCI) Medical Center — Irvine, California, United States
• VA Long Beach Healthcare System — Long Beach, California, United States
• VA Sacramento Medical Center — Mather, California, United States
• Balboa Nephrology — San Diego, California, United States
• University of South Florida — Tampa, Florida, United States
• Southwest Vascular Access Center — Alsip, Illinois, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Michigan Cardiovascular Institute — Flint, Michigan, United States
• Greenwood Leflore Hospital — Greenwood, Mississippi, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Rutgers-New Jersey Medical School — Newark, New Jersey, United States
• The Cardiovascular Care Group — Westfield, New Jersey, United States
• Duke University Hospital — Durham, North Carolina, United States
• Kaiser Permanente — Portland, Oregon, United States
• Medical University of South Carolina (MUSC) — Orangeburg, South Carolina, United States
• Baylor Scott and White Research Institute — Dallas, Texas, United States
• University of Wisconsin — Madison, Wisconsin, United States
• Universitätsklinikmn Erlangen, Gefäßchirurgie - Chirurgisches Zentrum — Erlangen, Bavaria, Germany
• Universitätsklinikum Frankfurt Klinik für Gefäß- und Endovascular-Chirurgie — Frankfurt am Main, Hesse, Germany
• The Chaim Sheba Medical Center — Ramat Gan, Tel Aviv, Israel

Full record on ClinicalTrials.gov

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