A Comparison Study of the Experimental Human Acellular Vessel For Dialysis in End-Stage Renal Disease

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Stem cell
Type: Biological study, Phase 3
Target:
10 Participants
Investigator:
Description
This research study is for patients with kidney failure, undergoing hemodialysis with a dialysis catheter. For long term hemodialysis, it's best to create a more permanent and safe route to connect your blood stream to the dialysis machine.

There are many ways to do this including surgically implanting a graft (a short piece of tubing). Another option is to surgically connect your artery and vein. This connection is called an autologous arteriovenous fistula or AVF.

This study will compare a new investigational graft developed by Humacyte (the Human Acellular Vessel or HAV) with an AVF.

This study will compare the ability of the HAV to function as an alternative to AVF for vascular access during hemodialysis.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  1. Subjects with end-stage renal disease (ESRD), receiving HD via DC and are suitable for the creation of an AVF or implantation of AVG for HD access.
  2. Subjects who plan to undergo HD at a dialysis unit of a participating dialysis provider for at least the first 6 months after SA creation.
  3. Subjects aged at least 18 years at Screening.
  4. Suitable anatomy for creation of a forearm or upper arm AVF and for implantation of straight or looped HAV in either the forearm or upper arm.
  5. Hemoglobin ≥8 g/dL and platelet count ≥100,000 /mm3.
  6. International Normalized Ratio (INR) ≤ 1.5.
  7. Female subjects must be either:
  8. 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).
  9. Or, of childbearing potential, in which case: i. Must have a negative urine or serum pregnancy test at Screening, and ii. Must agree to use at least one form of the following birth control methods for the duration of the study:
  10. Established use of oral, injectable or implanted hormonal methods of contraception.
  11. Placement of an intrauterine device or intrauterine system.
  12. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository.
  13. 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.
  14. Life expectancy of at least 2 years.

Exclusion criteria:

  1. Subjects who are optimal candidates for radiocephalic AVF as indicated by meeting ALL of the following criteria:
  2. No previous failed AVF.
  3. Cephalic vein diameter on ultrasound of more than 3.5mm.
  4. Radial artery diameter on ultrasound of more than 3mm.
  5. Vein depth of less than 0.5cm from the skin.
  6. Normal Allen's test indicating that ulnar artery flow to the hand is sufficient.
  7. No calcification in the wall of the distal radial artery.
  8. Sufficient length of the proposed fistula outflow vein to provide an adequate (at least 6 cm) cannulation segment.
  9. No evidence of iatrogenic injury to target artery or vein.
  10. Uncontrolled diabetes; a. HbA1c >10% (at Screening).
  11. History or evidence of severe peripheral arterial disease in the extremity selected for implant.
  12. Known or suspected central vein stenosis or obstruction on the side of planned SA creation, unless corrected prior to randomization.
  13. Planned AVF creation that requires more than one stage to complete. (e.g. basilic vein transposition AVF performed in 2 stages).
  14. Planned AVF creation by means other than suture or vascular anastomotic clips (e.g. endovascular surgery or other anastomotic creation devices).
  15. 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.
  16. Cancer that is actively being treated with a cytotoxic agent.
  17. Documented hyper-coagulable state.
  18. Bleeding diathesis.
  19. Active clinically significant immune-mediated disease, not controlled by maintenance immunosuppression.
  20. Low dose glucocorticoid therapy (e.g. 5-10mg prednisone [Deltason]) is acceptable.
  21. High dose glucocorticoid therapy for treatment of autoimmune flare, or other inflammatory diseases is excluded.
  22. Patients using glucocorticoids for immunosuppression post-transplant to prevent against transplanted allograft rejection in the period post allograft failure are excluded.
  23. The following examples of immunosuppressive agents (or the like) are exclusionary for enrollment in this clinical trial:
  24. tacrolimus or FK506 [Prograf]
  25. mycophenolate mofetil [Cellcept],
  26. cyclosporine [Sandimmune or Gengraf]
  27. sirolimus [Rapamune] (this only includes systemically administered, drug eluting stents are acceptable)
  28. Anticipated renal transplant within 6 months.
  29. History of heparin-induced thrombocytopenia.
  30. Venous outflow from SA cannot be located more centrally than the venous outflow of any previous failed access in that extremity.
  31. 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 SA creation.
  32. Known serious allergy or intolerance to aspirin and alternative antiplatelet therapy.
  33. Pregnant women, or women intending to become pregnant during the course of the trial.
  34. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SA.
  35. Previous enrollment in this study or any other study with HAV.
  36. Employees of Humacyte and employees or relatives of an investigator.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you $750 for your time and effort. This amount will be split into payments of $50, one for each visit completed (15 visits total).
Resources
Schedule
Study duration and period
We expect that you will be in this research study for up to 60 months depending on certain outcomes.
Recruitment period
From July 5, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
William Gruenloh
Research Topic
Conditions:
  • Renal Failure
  • End Stage Renal Disease
  • Hemodialysis
  • Vascular Access
  • Stem Cell