Multicenter, Double Blind, Placebo Controlled Study of Vonapanitase (PRT- 201) Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Phase of Trial: Phase III
Latest Information Update: 02 May 2017
At a glance
- Drugs Vonapanitase (Primary)
- Indications Thrombosis; Vascular disorders
- Focus Registrational; Therapeutic Use
- Acronyms PATENCY-2
- Sponsors Proteon Therapeutics
- 02 May 2017 Proteon has received written confirmation from the FDA that, if the PATENCY-2 trial is successful in showing statistical significance (p=0.05) on each of the co-primary endpoints, the PATENCY-2 trial together with data from previously completed studies would provide the basis for a BLA submission as a single pivotal study, according to a company media release.
- 02 May 2017 According to a company media release, Proteon Therapeutics has announced that it will increase the planned enrollment of this trial to 600 patients. The increased sample size follows a review of the statistical plan, which revealed a calculation error that overstated the trial's power for secondary patency, one of the co-primary endpoints. With this change in sample size, Proteon expects to complete enrollment in the first quarter of 2018 and to report top-line data in the first quarter of 2019.
- 02 May 2017 Planned number of patients changed from 500 to 600, according to a Proteon Therapeutics media release.