This research study is designed to assess the safety and effectiveness of an experimental drug called PRT-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. PRT-201 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 PRT-201 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
349
University of Alabama at Birmingham
Birmingham, Alabama, United States
AKDHC Medical Research Services , LLC
Phoenix, Arizona, United States
AKDHC Medical Research Services, LLc
Tucson, Arizona, United States
Alliance Research Center
Laguna Hills, California, United States
VA Medical Center Long Beach
Long Beach, California, United States
Time to AVF Primary Unassisted Patency
Primary unassisted patency defined as the time from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency.
Time frame: Days from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency, assessed up to 1 year
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 until AVF abandonment (secondary patency), assessed up to 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Keck University Hospital at USC
Los Angeles, California, United States
Kaiser Permanente Medical Center
San Diego, California, United States
California Institute of Renal Research
San Diego, California, United States
UCSF Division of Vascular & Endovascular Surgery
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Rush Medical Center
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