This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Humacyte, Inc.
Sponsor:
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
Humacyte, Inc.
ClinicalTrials.gov Identifier:
NCT02644941
First received: December 29, 2015
Last updated: May 23, 2017
Last verified: May 2017
  Purpose
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.

Condition Intervention Phase
Renal Failure End Stage Renal Disease Hemodialysis Vascular Access Biological: Human Acellular Vessel (HAV) Device: ePTFE graft Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Humacyte, Inc.:

Primary Outcome Measures:
  • Time to loss of Secondary Patency from implantation [ Time Frame: 12 months post-implantation ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 350
Actual Study Start Date: May 24, 2016
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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)
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.
Device: ePTFE graft
Surgical implantation of a commercially available ePTFE graft and subsequent use of the implanted vascular conduit for hemodialysis vascular 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02644941

Contacts
Contact: Angela Rose, MBA 919-313-9633 ext 185 rose@humacyte.com
Contact: Brant Hamle, PhD 919-313-9633 ext 245 hamel@humacyte.com

  Show 42 Study Locations
Sponsors and Collaborators
Humacyte, Inc.
CTI Clinical Trial and Consulting Services
Investigators
Study Director: Jeffrey H Lawson, MD, PhD Humacyte, Inc.
  More Information

Responsible Party: Humacyte, Inc.
ClinicalTrials.gov Identifier: NCT02644941     History of Changes
Other Study ID Numbers: CLN-PRO-V006
2015-003261-28 ( EudraCT Number )
Study First Received: December 29, 2015
Last Updated: May 23, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2017