This research study is designed to assess the safety and effectiveness of an experimental drug called vonapanitase (PRT-201) in patients both receiving or expecting to receive hemodialysis 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
696
University of Alabama at Birmingham
Birmingham, Alabama, United States
AKDHC Medical Research Services, LLC
Phoenix, Arizona, United States
Banner University Medical Center Tucson
Tucson, Arizona, United States
AKDHC Medical Research Services, LLc
Tucson, Arizona, United States
VA Loma Linda Healthcare System
Loma Linda, California, United States
Kaplan-Meier Estimate of Secondary AVF Patency
Kaplan-Meier estimate of median time from AVF creation until AVF abandonment (secondary patency)
Time frame: Median time from AVF creation to AVF abandonment (secondary patency), assessed up to 1 year.
Number of Participants With AVF Use for Hemodialysis
AVF use for hemodialysis is defined as the ability of the study AVF to be successfully cannulated and used for hemodialysis for a minimum of 90 days or at least 30 days prior to a patient's last visit, if hemodialysis has not been initiated at least 90 days prior to the patient's last visit. If AVF use is not defined as above, non-use of the AVF for hemodialysis is defined as an abandoned fistula prior to use; or if hemodialysis is recorded on 2 consecutive visits and there is no cannulation date or duration of use is less than 90 days. The patients who are not categorized as having use or non-use of the AVF have insufficient data to determine AVF use for hemodialysis and will be categorized as having indeterminate use.
Time frame: Assessed at up to 12 Months
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VA Medical Center Long Beach
Long Beach, California, United States
Keck University Hospital at USC
Los Angeles, California, United States
Kaiser Permanente
San Diego, California, United States
California Institute of Renal Research
San Diego, California, United States
Kaiser Permanente Northern California
San Francisco, California, United States
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