drugset / Trial / NCT01305824

A Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

NCT01305824 ↗

Phase 2 Completed 151 enrolled Proteon Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine if PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous fistula is safe and improves the patency of your fistula. PRT-201 is a protein that has been shown to help keep vessels open ("patent") when applied to the outside surface of the blood vessels (arteries and veins) in AVF patients in a previous study.

Timeline

Start
2011-03
Primary completion
2012-11
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator vonapanitase Protein / enzyme biologic 10 ug Topical
Comparator vonapanitase Protein / enzyme biologic 30 ug Topical