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

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ClinicalTrials.gov Identifier: NCT02644941
Recruitment Status : Active, not recruiting
First Posted : January 1, 2016
Last Update Posted : March 4, 2021
Sponsor:
Collaborators:
CTI Clinical Trial and Consulting Services
California Institute for Regenerative Medicine (CIRM)
Information provided by (Responsible Party):
Humacyte, Inc.

Tracking Information
First Submitted Date  ICMJE December 29, 2015
First Posted Date  ICMJE January 1, 2016
Last Update Posted Date March 4, 2021
Actual Study Start Date  ICMJE May 24, 2016
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
Time to loss of Secondary Patency from implantation [ Time Frame: 18 months post-implantation ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 30, 2015)
Time to loss of Secondary Patency from implantation [ Time Frame: 12 months post-implantation ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
  • Time to loss of Secondary Patency from implantation [ Time Frame: 12, 24 & 60 months post-implantation ]
  • Time to loss of Primary Patency from implantation [ Time Frame: 12,18, 24, & 60 months post-implantation ]
  • Access-related infections [ Time Frame: 12, 18, 24, & 60 months post-implantation ]
    Using Dialysis Event Surveillance Manual: CDC; 2013.
  • Rate of interventions required to achieve/maintain Secondary Patency [ Time Frame: 12, 18, 24, & 60 months post-implantation ]
  • Time to loss of Primary Assisted Patency from implantation [ Time Frame: 12, 18, 24, & 60 months post-implantation ]
  • Histopathological remodeling of any study conduit [ Time Frame: Up to 60 months post-implantation ]
    Microscopic examination of explanted conduit for cellular infiltration and extracellular remodeling processes, including neo-synthesis and reorganization of ECM components (descriptive summaries only)
  • The efficiency of dialysis as assessed by spKt/Vurea (subset of subjects) [ Time Frame: 12, 18 & 24 months post-implantation ]
  • Frequency and severity of AEs [ Time Frame: 12, 18, & 24 months post-implantation ]
  • True aneurysm formation (conduit lumen diameter >9mm) [ Time Frame: 12, 18, 24, & 60 months post-implantation ]
    Assessed by ultrasound
  • Pseudoaneurysm formation [ Time Frame: 12, 18, 24, & 60 months post-implantation ]
    Assessed by ultrasound
  • Study conduit rupture [ Time Frame: 12, 18, 24, & 60 months post-implantation ]
    Assessed by ultrasound
  • Anastomotic bleeding or rupture [ Time Frame: 12, 18, 24, & 60 months post-implantation ]
    Assessed by ultrasound
Original Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2015)
  • Time to loss of Secondary Patency from implantation [ Time Frame: 24 & 60 months post-implantation ]
  • Time to loss of Primary Patency from implantation [ Time Frame: 12, 24, & 60 months post-implantation ]
  • Access-related infections [ Time Frame: 12, 24, & 60 months post-implantation ]
    Using Dialysis Event Surveillance Manual: CDC; 2013.
  • Rate of interventions required to achieve/maintain Secondary Patency [ Time Frame: 12, 24, & 60 months post-implantation ]
  • Time to loss of Primary Assisted Patency from implantation [ Time Frame: 12, 24, & 60 months post-implantation ]
  • Histopathological remodeling of any study conduit [ Time Frame: 12, 24, & 60 months post-implantation ]
    Microscopic examination of explanted conduit for cellular infiltration and extracellular remodeling processes, including neo-synthesis and reorganization of ECM components (descriptive summaries only)
  • The efficiency of dialysis as assessed by spKt/Vurea (subset of subjects) [ Time Frame: 12 & 24 months post-implantation ]
  • Frequency and severity of AEs [ Time Frame: 12 & 24 months post-implantation ]
  • True aneurysm formation (conduit lumen diameter >9mm) [ Time Frame: 12, 24, & 60 months post-implantation ]
    Assessed by ultrasound
  • Pseudoaneurysm formation [ Time Frame: 12, 24, & 60 months post-implantation ]
    Assessed by ultrasound
  • Study conduit rupture [ Time Frame: 12, 24, & 60 months post-implantation ]
    Assessed by ultrasound
  • Anastomotic bleeding or rupture [ Time Frame: 12, 24, & 60 months post-implantation ]
    Assessed by ultrasound
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis
Official Title  ICMJE An Assessment of Humacyte's Human Acellular Vessel in Patients Needing Renal Replacement Therapy: A Comparison With ePTFE Grafts as Conduits for Hemodialysis (HUMANITY)
Brief Summary The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.
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.

On the day of surgery (Day 0), subjects could still be undergoing screening assessments, such as confirmation of inclusion/exclusion criteria, to determine their eligibility before they are randomized in the study. Eligible study subjects will be randomized to receive either a HAV or one of two commercially available ePTFE grafts and followed to 24 months post-implantation at routine study visits regardless of patency status. After 24 months, subjects with a patent study conduit will be followed (while the study conduit remains patent) for up to 5 years (60 months) post implantation at routine study visits.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Renal Failure
  • End Stage Renal Disease
  • Hemodialysis
  • Vascular Access
Intervention  ICMJE
  • Biological: Human Acellular Vessel (HAV)
    Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
    Other Name: (regulated as a biological product)
  • Device: ePTFE graft
    Surgical implantation of a commercially available ePTFE graft and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
Study Arms  ICMJE
  • Experimental: Human Acellular Vessel (HAV)
    The HAV is a tissue-engineered vascular conduit (6mm diameter) for hemodialysis access in patients with end-stage renal disease. It will be surgically implanted in the forearm or upper arm on Study Day 0.
    Intervention: Biological: Human Acellular Vessel (HAV)
  • Active Comparator: ePTFE
    The comparator (one of two commercially available 6mm ePTFE grafts) will be surgically implanted in the forearm or upper arm on Study Day 0.
    Intervention: Device: ePTFE graft
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 8, 2018)
355
Original Estimated Enrollment  ICMJE
 (submitted: December 30, 2015)
350
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with ESRD who are not, or who are no longer, candidates for creation of an autologous AV fistula and therefore need placement of an AV graft in the arm (upper- or forearm) to start or maintain hemodialysis therapy.
  • Either on hemodialysis or expected to start hemodialysis within 12 weeks of study conduit implantation.
  • At least 18 years of age at Screening.
  • 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), defined as:

    • ≤2x upper limit of normal (ULN) for serum bilirubin, aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase
    • ≤1.5 for International Normalized Ratio (INR) or prothrombin time (PT) ≤ 18 seconds unless the subject is taking an anticoagulant at the time
  • Female subjects must be either:

    • Of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile or post hysterectomy (at least 1 month prior to Screening)
    • Or, of childbearing potential, in which case:

      • Must have a negative urine pregnancy test at Screening, and
      • Must agree to use at least one form of the following birth control methods for the duration of the study:

        • Established use of oral, injectable or implanted hormonal methods of contraception
        • Placement of an intrauterine device or intrauterine system
        • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository
  • 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 obstruction on the side of planned implantation, unless corrected before study conduit implantation.
  • Treatment with any investigational drug or device within 60 days prior to study entry (Day 0) or ongoing participation in a clinical trial of an investigational product.
  • Cancer that is actively being treated with a cytotoxic agent.
  • Documented hyper-coagulable state.
  • Bleeding diathesis.
  • Active clinically significant autoimmune disease.
  • Anticipated renal transplant within 6 months.
  • Venous outflow from study conduit cannot be placed more centrally than any previous failed access.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Israel,   Poland,   Portugal,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02644941
Other Study ID Numbers  ICMJE CLN-PRO-V006
2015-003261-28 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Humacyte, Inc.
Study Sponsor  ICMJE Humacyte, Inc.
Collaborators  ICMJE
  • CTI Clinical Trial and Consulting Services
  • California Institute for Regenerative Medicine (CIRM)
Investigators  ICMJE
Study Director: Kiernan DeAngelis, MD Humacyte, Inc.
PRS Account Humacyte, Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP