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Title: Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients with Chronic Kidney Disease (PRT-201-201)
BIDMC Principal Investigator - Transplant / Dialysis Access Surgeon, Scott Johnson, MD
Type of Study - Interventional Phase II Drug Trial
Trial Status - Active, closed to enrollment.
Sponsor - Proteon Therapeutics
BIDMC Contact Person: Susan McDermott, RN, MPH: 617.632.9841 or firstname.lastname@example.org
Why Is This Study Being Done? - People with kidney failure often receive treatment called hemodialysis to remove the fluid and waste products from their body because the failed kidneys are no longer working. In order to perform hemodialysis a vascular access site (a site to connect dialysis tubing to blood vessels for the dialysis treatment) has to be created. An arterio venous fistula (AVF) is one type of vascular access for dialysis. It is created by connecting one of the patient's arteries to one of their veins. Sometimes AVFs do not work after they are created, some fail because the vein does not dilate (get larger) enough to be suitable for hemodialysis, sometimes the AVF becomes obstructed. This new drug, PRT-201, is being developed as a treatment to keep the blood vessels used for hemodialysis open ("patent").
The purpose of this study is to determine if PRT-201 is safe and improves the patency of arteriovenous fistulas in patients with chronic kidney disease preparing for hemodialysis treatments.
What's Involved? - Patients with chronic kidney disease who are scheduled for surgery for AVF creation may be eligible to participate in this study. Study staff complete screening procedures including examinations and blood and urine test prior to surgery. Participants are randomized to receive PRT201 or placebo (inactive drug). The study drug is applied to the site of the newly created AVF prior to the end of the surgical procedure. Six (6) study follow up visits will be completed over a one year period following the surgery.
Find out More on the National Clinical Trials Registry: This study and other clinical trials are included in the National Clinical Trials Registry, which summarizes information about a clinical trial's purpose, who may participate, trial site locations, and contact phone numbers. Related research publications and study results are also posted to the Registry site as they become available.