Multicenter, Double Blind, Placebo Controlled Study of Vonapanitase (PRT- 201) Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

Trial Profile

Multicenter, Double Blind, Placebo Controlled Study of Vonapanitase (PRT- 201) Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

Recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Oct 2017

At a glance

  • Drugs Vonapanitase (Primary)
  • Indications Thrombosis; Vascular disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms PATENCY-2
  • Sponsors Proteon Therapeutics
  • Most Recent Events

    • 19 Oct 2017 Planned primary completion date changed from 1 Nov 2018 to 1 Feb 2019.
    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top