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.

Study Overview

• Status: Completed
• Conditions: Renal Failure; Hemodialysis; End Stage Renal Disease; Vascular Access
• Intervention / Treatment: Biological: Human Acellular Vessel (HAV); Device: ePTFE graft

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 355
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • Universitätsklinikmn Erlangen, Gefäßchirurgie - Chirurgisches Zentrum
  • Hessen
    • Frankfurt/Main, Hessen, Germany, 60590
      • Universitätsklinikum Frankfurt Klinik für Gefäß- und Endovascular-Chirurgie
• Israel
  • Hadera, Israel, 38100
    • Hillel Jaffe Medical Center
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Jerusalem, Israel, 9103102
    • Sharee Zedek Medical Center
  • Tzrifin, Israel, 70300
    • Yitzhak Shamir Medical Center - Assaf Harofeh
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 52621
      • The Chaim Sheba Medical Center
• Poland
  • Poznan, Poland, 61-848
    • Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
  • Warszawa, Poland, 02-097
    • Samodzielny Publiczyn Centralny Szpital Klinziczny w Warszawie - Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
  • Wroclaw, Poland, 51-124
    • Wojewódzki Szpital Specjalistyczny we Wrocławiu
• Portugal
  • Porto, Portugal, 4050-190
    • Grupo de Estudos Vasculares
• United Kingdom
  • Glasgow, United Kingdom, G51 4TF
    • Queen Elizabeth University Hospital Glasgow
  • Leeds, United Kingdom, LS1 3EX
    • Leeds General Infirmary
  • East Midlands/ Leicestershire
    • Leicester, East Midlands/ Leicestershire, United Kingdom, LE5 4PW
      • Leicester General Hospital
  • Greater London
    • London, Greater London, United Kingdom, SE1 9RT
      • Guy´s Hospital, Kings´College London
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B15 2TH
      • Queen Elizabeth Hospital Birmingham
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Arizona Kidney Disease and Hypertension Center (AKDHC)
    • Tucson, Arizona, United States, 85745
      • Carondelet St. Mary's Hospital
  • California
    • Fresno, California, United States, 93710
      • Ladenheim Dialysis Access Center
    • Fresno, California, United States, 93720
      • General Surgery and Vascular Access
    • Irvine, California, United States, 92868
      • University of California Irvine (UCI) Medical Center
    • Long Beach, California, United States, 90822
      • VA Long Beach Healthcare System
    • Mather, California, United States, 95655
      • VA Sacramento Medical Center
    • San Diego, California, United States, 92123
      • Balboa Nephrology
  • Florida
    • Tampa, Florida, United States, 33606
      • University Of South Florida
  • Illinois
    • Alsip, Illinois, United States, 60803
      • Southwest Vascular Access Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • Michigan
    • Flint, Michigan, United States, 48507
      • Michigan Cardiovascular Institute
  • Mississippi
    • Greenwood, Mississippi, United States, 38930
      • Greenwood Leflore Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Rutgers-New Jersey Medical School
    • Westfield, New Jersey, United States, 07090
      • The Cardiovascular Care Group
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Hospital
  • Oregon
    • Portland, Oregon, United States, 97201
      • Kaiser Permanente
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • Medical University of South Carolina (MUSC)
  • Texas
    • Dallas, Texas, United States, 75226
      • Baylor Scott and White Research Institute
  • Wisconsin
    • Madison, Wisconsin, United States, 53706
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Human Acellular Vessel (HAV); HAV-tissue-engineered vascular conduit (6mm diameter)	Biological: Human Acellular Vessel (HAV); HAV-tissue-engineered vascular conduit (6mm diameter); Other Names: (regulated as a biological product)
Active Comparator: ePTFE; One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)	Device: ePTFE graft; One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Loss of Secondary Patency	Defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions (Sidawy et al. 2002).; "Abandonment" defined as no remaining segment of the study conduit was incorporated into the vascular access circuit used for dialysis (conversely, if some portion of the study conduit was still being used for dialysis it was not considered abandoned).	12 months post-implantation
Number of Participants With Loss of Secondary Patency	Defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions (Sidawy et al. 2002).; "Abandonment" defined as no remaining segment of the study conduit was incorporated into the vascular access circuit used for dialysis (conversely, if some portion of the study conduit was still being used for dialysis it was not considered abandoned).	18 months post-implantation
Number of Participants With Loss of Secondary Patency	Defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions (Sidawy et al. 2002).; "Abandonment" defined as no remaining segment of the study conduit was incorporated into the vascular access circuit used for dialysis (conversely, if some portion of the study conduit was still being used for dialysis it was not considered abandoned).	24 months post-implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Loss of Primary Patency	Use of duplex ultrasonography to assess study conduit patency. Loss of primary patency occurs when any intervention is performed on the conduit regardless of whether the conduit thrombosed.	12 months post-implantation
Number of Participants With Loss of Primary Patency	Use of duplex ultrasonography to assess study conduit patency. Loss of primary patency occurs when any intervention is performed on the conduit regardless of whether the conduit thrombosed.	18 months post-implantation
Number of Participants With Loss of Primary Patency	Use of duplex ultrasonography to assess study conduit patency. Loss of primary patency occurs when any intervention is performed on the conduit regardless of whether the conduit thrombosed.	24 months post-implantation
Number of Participants With Loss of Primary Patency	Duplex ultrasound was used to assess study conduit patency. Loss of primary patency occurs when any intervention is performed on the conduit regardless of whether the conduit thrombosed.	60 months post-implantation
Study Conduit Abandonment	No remaining segment of the study conduit is incorporated into the vascular access circuit used for dialysis.	24 months post-implantation
Study Conduit Abandonment	No remaining segment of the study conduit is incorporated into the vascular access circuit used for dialysis.	60 months post-implantation
Rate of Adjudicated Study Conduit Access Related Infections	Adjudicated using the standard definition of access-related infections (CDC; 2013).	24 months post-implantation
Access-related Infections	Using Dialysis Event Surveillance Manual: CDC; 2013.	60 months post-implantation
Participants With at Least 1 Intervention Required to Achieve/Maintain Secondary Patency	Rate of intervention defined as the number of interventions per participant per year while conduit is patent (i.e., has not been abandoned). Number of successful interventions to achieve/maintain Secondary Patency.	24 months post-implantation
Total Interventions Performed to Maintain Secondary Patency (Ballon Size Not > 6 Millimeters)	Total number of interventions performed by treatment group stratified by any use of balloon size no > 6 millimeters.	60 months post-implantation
Total Interventions Performed to Maintain Secondary Patency (Balloon Size > 6 Millimeters)	Total number of interventions performed by treatment group stratified by any use of balloon size greater than 6 millimeters.	60 months post-implantation
Thrombosis of Study Access That Required Intervention	Total number of thrombosis events (per each treatment group) that required an intervention to maintain the functionality of patent access	24 months post-implantation
Thrombosis of Study Access That Required Intervention	Total number of thrombosis events (per each treatment group) that required an intervention to maintain the functionality of patent access	60 months post-implantation
Dialysis Efficiency as Measured by spKt/Vurea (Subset of Subjects)	Dialysis efficiency as assessed by spKt/Vurea (obtained from dialysis unit for a subset of subjects) will be summarized descriptively. The most recent available data prior to the study visits will be used for the analysis. Twenty sites provided at least 1 spKt/Vurea measurement. spKt/Vurea: measure of dialysis adequacy for a single hemodialysis treatment using the single pooled method.	2 to 18 Months post-implantation
Severity of Adverse Events	Severity Assessment Standard; Mild: Events require minimal or no treatment and do not interfere with the subject's daily activities.; Moderate: Events result in a low level of inconvenience or concern with the therapeutic measures. May cause some interference with functioning.; Severe: Events interrupt a subject's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually incapacitating.; Life-threatening: Any adverse event that places the subject or participant, in the view of the investigator, at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction that, had it occurred in a more severe form, might have caused death.; Death: Death related to Adverse Event.	24 months post-implantation
Number of Participants With at Least One Adverse Event	Collection of all Adverse Events beginning on Day 0 after implantation up to 2 years post implantation (Month 24).	24 months post-implantation
True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters)	Assessed by ultrasound: at least a 50% increase over the 6 millimeter baseline	24 months post-implantation
True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters)	Assessed by ultrasound: at least a 50% increase over the 6 millimeter baseline	60 months post-implantation
Pseudoaneurysm Formation	Use of duplex ultrasound to assess the diameter of the lumen mid-conduit. The outcome measures data represents the total number of pseudoaneurysms.	24 months post-implantation
Pseudoaneurysm Formation	Use of duplex ultrasound to assess the diameter of the lumen mid-conduit. The outcome measures data represents the total number of pseudoaneurysms.	60 months post-implantation
Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury	Assessed by ultrasound	24 months post-implantation
Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury	Assessed by ultrasound	60 months post-implantation
Anastomotic Bleeding or Rupture	Assessed by ultrasound	24 months post-implantation
Anastomotic Bleeding or Rupture	Assessed by ultrasound	60 months post-implantation
Calculated Panel Reactive Antibody More Than 20% Change From Baseline	Increase in Panel Reactive Antibody more than 20% (highly sensitized) from baseline	18 months post-implantation
Calculated Panel Reactive Antibody More Than 20% Change From Baseline	Increase in Panel Reactive Antibody more than 20% (highly sensitized) from baseline	24 months post-implantation
Mean Inner Diameter of Conduit (Millimeter)	Duplex ultrasonography: diameter of the mid-conduit lumen	12 months post-implantation
Mean Inner Diameter of Conduit (Millimeter)	Duplex ultrasonography: diameter of the mid-conduit lumen	24 months post-implantation
Mean Inner Diameter of Conduit (Millimeter)	Duplex ultrasonography: diameter of the mid-conduit lumen	60 months post-implantation

Collaborators and Investigators

• Sponsor: Humacyte, Inc.
• Collaborators: California Institute for Regenerative Medicine (CIRM); CTI Clinical Trial and Consulting Services
• Investigators: Study Director: Shamik Parikh, MD, Humacyte, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2016
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: December 29, 2015
• First Submitted That Met QC Criteria: December 30, 2015
• First Posted (Estimated): January 1, 2016

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: CLN-PRO-V006; 2015-003261-28 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO