A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease
Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
Summary
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.