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HUMANITY Clinical Trial for AV Access

Humacyte HUMANITY™
Phase III Clinical Trial

STUDY POPULATION:
Patients with kidney failure who are not or are no longer candidates for fistula placement

STUDY:
Approximately 35 Sites in the US, Europe, and Israel; total of 355 patients

EXPECTED START DATE:
May 2016

FOLLOW UP PERIOD:
Up to 5 years

FOLLOW UP PERIOD:
Local research coordinator

Thank you for being a part of the HUMANITY™ AV access clinical trial. This Phase III study will compare hemodialysis access with the Human Acellular Vessel (HAV) to that with an expanded polytetrafluoroethylene (ePTFE) graft, the current standard of care for patients not suitable for fistulas. Thank you for your willingness to participate in important clinical research. Below you can learn more about the HUMANITY™ clinical trial, the Humacyte vessel and our technology.

Content approved by WIRB 28May2016

Clinical Trial Synopsis

An Assessment of Humacyte’s Human Acellular Vessel in Patients Needing Renal Replacement Therapy: A Comparison with ePTFE Grafts as Conduits for Hemodialysis (HUMANITY™).

Patients with end-stage renal disease (kidney failure) who require hemodialysis, but have unsuitable vessels for creation of a dialysis fistula for access will be chosen to participate in this prospective, multicenter, multinational, randomized, comparative study. Patients will be implanted in the forearm or upper arm with either a Humacyte Vessel (HAV) or a dialysis graft, the standard of care. The 1:1 randomization (a 50/50 chance of receiving the HAV or standard graft) will occur during surgery once your surgeon has determined where the study conduit should be placed. All patients will be required to take daily aspirin (75 to 325 mg) unless they are already taking another antiplatelet agent (e.g., Plavix).

Each patient will be followed by study specific visits through 2 years (24 months) of follow up after implantation (whether the vessel or graft is open and functioning or not). After 2 years, only subjects with an open and functioning access will be followed (while the access remains open) for up to 5 years (60 months) post-implantation at routine study visits.

SCHEDULE OF STUDY SPECIFIC VISITS

  • Screening Visit (up to 35 days
    prior to surgery date)
  • Day 0 (Surgery day)
  • Post op Day 7-15
  • 1 month
  • 2 months
  • 3 months
  • 6 months
  • 9 months
  • 1 year
  • 18 months
  • 2 years
  • Visits will continue every
    6 months from month 30 – 60
    as long as the access remains
    open and functional
All visits include:
  • A general physical exam
  • Evaluation of the study access
  • Documentation of:
    • Problems
    • Work done to the study access
    • Perm cath placement
    • Medications
Some visits will include:
  • Ultrasound imaging of the study
    access
  • Lab work

Humacyte Vessel

The HUMACYTE HAV is a tissue-engineered blood vessel that is being investigated as a surgical option for vascular access. The HAV is a sterile, vascular tube, composed of human connective tissue and proteins. This complex connective tissue has similarities to human vascular tissue but HAV is non-living.

To read more about the Humacyte HAV, click here.