Proteon Therapeutics, Inc. announced results from its Phase 2 clinical trial of PRT-201 in chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF) in preparation for hemodialysis. The Phase 2 results demonstrated that treatment with PRT-201 prolonged primary unassisted patency and improved the rate of AVF maturation. Additionally, PRT-201 was well tolerated at the doses tested.

The arteriovenous fistula is the optimal form of vascular access for hemodialysis patients because it is associated with reduced morbidity and lower costs. However, AVFs frequently suffer from neointimal hyperplasia and stenosis formation, resulting in maturation failure and loss of patency. The randomized, double-blind, placebo-controlled Phase 2 study evaluated the safety and efficacy of PRT-201 delivery immediately following surgical creation of an AVF.

A total of 151 patients were randomized to one of two doses of PRT-201, or placebo. The primary endpoint was the duration of unassisted primary patency, defined as the time from surgical creation of the AVF until thrombosis or the occurrence of a procedure to maintain or restore patency. AVF maturation was a secondary efficacy endpoint.