A Study of Vonapanitase Administered Immediately After Radiocephalic Arteriovenous Fistula (AVF) Creation in Patients With Chronic Kidney Disease (CKD)

What we are studying

This research study is designed to assess the safety and effectiveness of an experimental drug called vonapanitase (PRT-201) in patients who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. Vonapanitase is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether vonapanitase when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Life expectancy of at least 6 months
  • Diagnosis of chronic kidney disease
  • Planned creation of a new radiocephalic AVF (revision of an existing AVF is not eligible)
  • If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the Screening visit and be willing to use contraception from the time of the Screening visit to 2 weeks following study drug administration

What is involved

  • 8 study visits over 13 months
  • 1 surgery (already planned
  • Not covered by study) for radiocephalic AVF creation
  • 2 AVF ultrasounds
  • 7 AVF exams
  • 3 blood draws

Compensation

$50 Walmart giftcard/completed visit

Contact Information

Study Coordinator
Kendrah Kidd
Email
kkidd@wakehealth.edu
Phone
716-7162
Principal Investigator
Anthony J. Bleyer, MD, MS

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.