PATENCY-2 phase III trial of vonapanitase fails to meet primary endpoint in chronic kidney disease

Proteon Therapeutics announced results from PATENCY-2, its Phase III clinical trial of investigational vonapanitase in patients with chronic kidney disease (CKD) undergoing creation of a radiocephalic fistula for hemodialysis. This study did not meet its co-primary endpoints of fistula use for hemodialysis (p=0.328) and secondary patency (p=0.932). The adverse events with vonapanitase were similar to placebo and consistent with previous clinical trials. PATENCY-2 evaluated the safety and efficacy of a single dose of investigational vonapanitase in patients with CKD undergoing creation of a radiocephalic arteriovenous fistula for hemodialysis. The multicenter, randomized, double-blind, placebo-controlled PATENCY-2 trial treated 603 patients at 39 medical centers in the United States and Canada. Patients were followed for up to one year.

Top-line results also included data relating to primary unassisted patency, one of PATENCY-2’s other efficacy endpoints. Primary unassisted patency is the length of time from fistula surgical creation to the first occurrence of a fistula thrombosis or corrective procedure to restore or maintain patency (blood flow). Vonapanitase-treated patients had a 15% reduction in the risk of primary unassisted patency loss over one year, compared to placebo (p=0.178), a result that is not statistically significant. At the end of one year, 50% of patients who received vonapanitase retained primary unassisted patency, compared to 43% of placebo-treated patients.