Skip to main content
OpenTrials
Completed

NCT Number: NCT02644941

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Failure Chronic Disease Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Access

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitätsklinikmn Erlangen, Gefäßchirurgie - Chirurgisches Zentrum, Erlangen, Bavaria, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Human Acellular Vessel (HAV)

Biological

HAV-tissue-engineered vascular conduit (6mm diameter)

Other names: (regulated as a biological product)

ePTFE graft

Device

One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)

Primary outcomes

  1. Number of Participants With Loss of Secondary Patency

    Time frame: 12 months post-implantation

    • 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).

  2. Number of Participants With Loss of Secondary Patency

    Time frame: 18 months post-implantation

    • 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).

  3. Number of Participants With Loss of Secondary Patency

    Time frame: 24 months post-implantation

    • 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).

Secondary outcomes

  1. Number of Participants With Loss of Primary Patency

    Time frame: 12 months post-implantation

    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.

  2. Number of Participants With Loss of Primary Patency

    Time frame: 18 months post-implantation

    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.

  3. Number of Participants With Loss of Primary Patency

    Time frame: 24 months post-implantation

    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.

  4. Number of Participants With Loss of Primary Patency

    Time frame: 60 months post-implantation

    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.

  5. Study Conduit Abandonment

    Time frame: 24 months post-implantation

    No remaining segment of the study conduit is incorporated into the vascular access circuit used for dialysis.

  6. Study Conduit Abandonment

    Time frame: 60 months post-implantation

    No remaining segment of the study conduit is incorporated into the vascular access circuit used for dialysis.

  7. Rate of Adjudicated Study Conduit Access Related Infections

    Time frame: 24 months post-implantation

    Adjudicated using the standard definition of access-related infections (CDC; 2013).

  8. Access-related Infections

    Time frame: 60 months post-implantation

    Using Dialysis Event Surveillance Manual: CDC; 2013.

  9. Participants With at Least 1 Intervention Required to Achieve/Maintain Secondary Patency

    Time frame: 24 months post-implantation

    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.

  10. Total Interventions Performed to Maintain Secondary Patency (Ballon Size Not > 6 Millimeters)

    Time frame: 60 months post-implantation

    Total number of interventions performed by treatment group stratified by any use of balloon size no > 6 millimeters.

  11. Total Interventions Performed to Maintain Secondary Patency (Balloon Size > 6 Millimeters)

    Time frame: 60 months post-implantation

    Total number of interventions performed by treatment group stratified by any use of balloon size greater than 6 millimeters.

  12. Thrombosis of Study Access That Required Intervention

    Time frame: 24 months post-implantation

    Total number of thrombosis events (per each treatment group) that required an intervention to maintain the functionality of patent access

  13. Thrombosis of Study Access That Required Intervention

    Time frame: 60 months post-implantation

    Total number of thrombosis events (per each treatment group) that required an intervention to maintain the functionality of patent access

  14. Dialysis Efficiency as Measured by spKt/Vurea (Subset of Subjects)

    Time frame: 2 to 18 Months post-implantation

    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.

  15. Severity of Adverse Events

    Time frame: 24 months post-implantation

    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.

  16. Number of Participants With at Least One Adverse Event

    Time frame: 24 months post-implantation

    Collection of all Adverse Events beginning on Day 0 after implantation up to 2 years post implantation (Month 24).

  17. True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters)

    Time frame: 24 months post-implantation

    Assessed by ultrasound: at least a 50% increase over the 6 millimeter baseline

  18. True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters)

    Time frame: 60 months post-implantation

    Assessed by ultrasound: at least a 50% increase over the 6 millimeter baseline

  19. Pseudoaneurysm Formation

    Time frame: 24 months post-implantation

    Use of duplex ultrasound to assess the diameter of the lumen mid-conduit. The outcome measures data represents the total number of pseudoaneurysms.

  20. Pseudoaneurysm Formation

    Time frame: 60 months post-implantation

    Use of duplex ultrasound to assess the diameter of the lumen mid-conduit. The outcome measures data represents the total number of pseudoaneurysms.

  21. Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury

    Time frame: 24 months post-implantation

    Assessed by ultrasound

  22. Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury

    Time frame: 60 months post-implantation

    Assessed by ultrasound

  23. Anastomotic Bleeding or Rupture

    Time frame: 24 months post-implantation

    Assessed by ultrasound

  24. Anastomotic Bleeding or Rupture

    Time frame: 60 months post-implantation

    Assessed by ultrasound

  25. Calculated Panel Reactive Antibody More Than 20% Change From Baseline

    Time frame: 18 months post-implantation

    Increase in Panel Reactive Antibody more than 20% (highly sensitized) from baseline

  26. Calculated Panel Reactive Antibody More Than 20% Change From Baseline

    Time frame: 24 months post-implantation

    Increase in Panel Reactive Antibody more than 20% (highly sensitized) from baseline

  27. Mean Inner Diameter of Conduit (Millimeter)

    Time frame: 12 months post-implantation

    Duplex ultrasonography: diameter of the mid-conduit lumen

  28. Mean Inner Diameter of Conduit (Millimeter)

    Time frame: 24 months post-implantation

    Duplex ultrasonography: diameter of the mid-conduit lumen

  29. Mean Inner Diameter of Conduit (Millimeter)

    Time frame: 60 months post-implantation

    Duplex ultrasonography: diameter of the mid-conduit lumen

Sponsors and collaborators

Lead sponsor

Humacyte, Inc.

Industry

Collaborators

  • CTI Clinical Trial and Consulting Services
  • California Institute for Regenerative Medicine (CIRM)

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2019
Study completion
2023
First posted
Jan 1, 2016
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.