Renal FailurePhase 3NCT02644941
Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis
A Phase 3 study testing Human Acellular Vessel (HAV) and ePTFE graft in people with Renal Failure and End Stage Renal Disease, run by Humacyte, Inc. at 38 sites in 6 countries.
Trial summary
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, End Stage Renal Disease, Hemodialysis
- What is being tested?
- Human Acellular Vessel (HAV) and ePTFE graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 38 sitesin 6 countries
- Study dates
- 24 May 2016to Sep 2023
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
38 sites in 6 countries.
38 sites in 6 countries
United States22 sites
Southwest Vascular Access Center
Alsip, Illinois, 60803
University of Maryland Medical Center
Baltimore, Maryland, 21201
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Baylor Scott and White Research Institute
Dallas, Texas, 75226
Duke University Hospital
Durham, North Carolina, 27705
Michigan Cardiovascular Institute
Flint, Michigan, 48507
Ladenheim Dialysis Access Center
Fresno, California, 93710
General Surgery and Vascular Access
Fresno, California, 93720
Greenwood Leflore Hospital
Greenwood, Mississippi, 38930
University of California Irvine (UCI) Medical Center
Irvine, California, 92868
VA Long Beach Healthcare System
Long Beach, California, 90822
University of Wisconsin
Madison, Wisconsin, 53706
VA Sacramento Medical Center
Mather, California, 95655
Rutgers-New Jersey Medical School
Newark, New Jersey, 07103
Medical University of South Carolina (MUSC)
Orangeburg, South Carolina, 29118
Arizona Kidney Disease and Hypertension Center (AKDHC)
Phoenix, Arizona, 85012
Kaiser Permanente
Portland, Oregon, 97201
Balboa Nephrology
San Diego, California, 92123
Washington University School of Medicine
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33606
Carondelet St. Mary's Hospital
Tucson, Arizona, 85745
The Cardiovascular Care Group
Westfield, New Jersey, 07090
Israel5 sites
Hillel Jaffe Medical Center
Hadera, 38100
Rambam Health Care Campus
Haifa, Haifa District, 3109601
Sharee Zedek Medical Center
Jerusalem, 9103102
The Chaim Sheba Medical Center
Ramat Gan, Tel Aviv, 52621
Yitzhak Shamir Medical Center - Assaf Harofeh
Tzrifin, 70300
United Kingdom5 sites
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, B15 2TH
Queen Elizabeth University Hospital Glasgow
Glasgow, G51 4TF
Leeds General Infirmary
Leeds, LS1 3EX
Leicester General Hospital
Leicester, East Midlands/ Leicestershire, LE5 4PW
Guy´s Hospital, Kings´College London
London, Greater London, SE1 9RT
Poland3 sites
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
Poznan, 61-848
Samodzielny Publiczyn Centralny Szpital Klinziczny w Warszawie - Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, 02-097
Wojewódzki Szpital Specjalistyczny we Wrocławiu
Wroclaw, 51-124
Germany2 sites
Universitätsklinikmn Erlangen, Gefäßchirurgie - Chirurgisches Zentrum
Erlangen, Bavaria, 91054
Universitätsklinikum Frankfurt Klinik für Gefäß- und Endovascular-Chirurgie
Frankfurt am Main, Hesse, 60590
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Failure, End Stage Renal Disease, Hemodialysis, Vascular Access
- Being tested
- Human Acellular Vessel (HAV), ePTFE graft
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Acellular Vessel (HAV)Biological
Also called (regulated as a biological product)
HAV-tissue-engineered vascular conduit (6mm diameter)
ePTFE graftDevice
One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
| Study group | Role | What they receive |
|---|---|---|
| Human Acellular Vessel (HAV) | Experimental | HAV-tissue-engineered vascular conduit (6mm diameter) Receives: Biological: Human Acellular Vessel (HAV) |
| ePTFE | Active comparator | One of two commercially available comparators (Bard Impra® and Gore PROPATEN®) Receives: Device: ePTFE graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 24 months post-implantation
Secondary outcomes (29)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 60 months post-implantation
Study Conduit Abandonment
No remaining segment of the study conduit is incorporated into the vascular access circuit used for dialysis.
Measured: 24 months post-implantation
Study Conduit Abandonment
No remaining segment of the study conduit is incorporated into the vascular access circuit used for dialysis.
Measured: 60 months post-implantation
Rate of Adjudicated Study Conduit Access Related Infections
Adjudicated using the standard definition of access-related infections (CDC; 2013).
Measured: 24 months post-implantation
Access-related Infections
Using Dialysis Event Surveillance Manual: CDC; 2013.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 60 months post-implantation
Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury
Assessed by ultrasound
Measured: 24 months post-implantation
Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury
Assessed by ultrasound
Measured: 60 months post-implantation
Anastomotic Bleeding or Rupture
Assessed by ultrasound
Measured: 24 months post-implantation
Anastomotic Bleeding or Rupture
Assessed by ultrasound
Measured: 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
Measured: 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
Measured: 24 months post-implantation
Mean Inner Diameter of Conduit (Millimeter)
Duplex ultrasonography: diameter of the mid-conduit lumen
Measured: 12 months post-implantation
Mean Inner Diameter of Conduit (Millimeter)
Duplex ultrasonography: diameter of the mid-conduit lumen
Measured: 24 months post-implantation
Mean Inner Diameter of Conduit (Millimeter)
Duplex ultrasonography: diameter of the mid-conduit lumen
Measured: 60 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study start24 May 2016
- Primary completionMay 2019
- Study completionSep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humacyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTI Clinical Trial and Consulting Services, California Institute for Regenerative Medicine (CIRM)
- Responsible party
- Sponsor
- Investigators
- Shamik Parikh, MD, Study director, Humacyte, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644941
- Sponsor's protocol ID
- CLN-PRO-V006
- Other IDs
- 2015-003261-28, 2015
- Status last verified
- Jul 2026
- First submitted
- 29 Dec 2015
- Last updated
- 19 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37662589