Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis
NCT ID: NCT02644941
Last Updated: 2025-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
355 participants
INTERVENTIONAL
2016-05-24
2023-09-30
Brief Summary
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Detailed Description
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Participants who consented were randomized to the HAV treatment arm of one of the two commercially available comparators.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Human Acellular Vessel (HAV)
HAV-tissue-engineered vascular conduit (6mm diameter)
Human Acellular Vessel (HAV)
HAV-tissue-engineered vascular conduit (6mm diameter)
ePTFE
One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
ePTFE graft
One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Interventions
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Human Acellular Vessel (HAV)
HAV-tissue-engineered vascular conduit (6mm diameter)
ePTFE graft
One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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CTI Clinical Trial and Consulting Services
OTHER
California Institute for Regenerative Medicine (CIRM)
OTHER
Humacyte, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Shamik Parikh, MD
Role: STUDY_DIRECTOR
Humacyte, Inc.
Locations
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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
Hillel Jaffe Medical Center
Hadera, , Israel
Rambam Health Care Campus
Haifa, , Israel
Sharee Zedek Medical Center
Jerusalem, , Israel
Yitzhak Shamir Medical Center - Assaf Harofeh
Tzrifin, , Israel
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
Poznan, , Poland
Samodzielny Publiczyn Centralny Szpital Klinziczny w Warszawie - Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, , Poland
Wojewódzki Szpital Specjalistyczny we Wrocławiu
Wroclaw, , Poland
Grupo de Estudos Vasculares
Porto, , Portugal
Leicester General Hospital
Leicester, East Midlands/ Leicestershire, United Kingdom
Guy´s Hospital, Kings´College London
London, Greater London, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, United Kingdom
Queen Elizabeth University Hospital Glasgow
Glasgow, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
Countries
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References
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Wang J, Blalock SKF, Levitan GS, Prichard HL, Niklason LE, Kirkton RD. Biological mechanisms of infection resistance in tissue engineered blood vessels compared to synthetic expanded polytetrafluoroethylene grafts. JVS Vasc Sci. 2023 Jul 14;4:100120. doi: 10.1016/j.jvssci.2023.100120. eCollection 2023.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-003261-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLN-PRO-V006
Identifier Type: -
Identifier Source: org_study_id
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