PRT-201 is a recombinant human type-I pancreatic elastase intended for local, long-lasting dilation of the AVG venous anastomosis and outflow vein. The goal of the treatment is to improve primary patency and long-term survival of AVGs and thereby provide patients with chronic kidney disease (CKD) a reliable and durable vascular access site for hemodialysis. Recent data indicate that up to three quarters of patients have loss of graft patency at one year, indicating a substantial need for new therapies. This clinical trial will explore the safety and dilatory effect of topically administered PRT-201 on the outflow vein of a newly placed upper extremity AVG.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
89
Applied topically during surgery.
Applied topically during surgery
Ladenheim Dialysis Access Center
Fresno, California, United States
California Institute of Renal Research
San Diego, California, United States
Washington Hospital/Medstar Research
Washington D.C., District of Columbia, United States
Indiana/Ohio Heart
Fort Wayne, Indiana, United States
Indiana University/Purdue University
Indianapolis, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Vascular Specialty Center
Baton Rouge, Louisiana, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts, United States
Weill Cornell Medical College
New York, New York, United States
...and 6 more locations
To assess the safety of a single topical dose of PRT-201.
Time frame: Day of AVG creation and 4 weeks After surgery.
Primary graft patency
Time frame: 3, 6, 9 and 12 months after AVG creation.
Secondary graft patency.
Time frame: 3, 6, 9 and 12 months after AVG creation.
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