Conditions: Chronic Kidney Disease
Keywords: radiocephalic arteriovenous fistula AVF hemodialysis PRT-201 vascular access kidney renal vonapanitase PATENCY-1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 349
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: PRT-201 administered at the time of radiocephalic fistula creation arm 2: Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition to PRT-201 but lacks the active ingredient.

Interventions: intervention 1: PRT-201 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: