Trials / Completed
CompletedNCT02110901
A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)
Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 349 (actual)
- Sponsor
- Proteon Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
This research study is designed to assess the safety and effectiveness of an experimental drug called PRT-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. PRT-201 is a protein that has been shown in previous research studies to help keep vessels patent when applied to the outside surface of the blood vessels (arteries and veins) in patients who undergo surgery to create an arteriovenous fistula (AVF). The purpose of this study is to determine whether PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery is safe and improves the patency of your AVF.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PRT-201 | |
| DRUG | Placebo |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2016-12-01
- Completion
- 2018-12-01
- First posted
- 2014-04-10
- Last updated
- 2019-07-09
- Results posted
- 2019-07-09
Locations
35 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02110901. Inclusion in this directory is not an endorsement.