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NCT02414841 · ClinicalTrials.gov registry record · Phase 3
A Study of Vonapanitase (PRT-201) Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-2)
A Phase 3 study, sponsored by Proteon Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 696
- Enrollment target
NCT02414841: Completed Phase 3 study, sponsored by Proteon Therapeutics.
NCT02414841 is a Phase 3 study that has completed, run by Proteon Therapeutics. The registered enrollment target is 696 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02414841, a Phase 3 study, has completed, sponsored by Proteon Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 696 participants
- Enrollment target
Study Summary
This research study is designed to assess the safety and effectiveness of an experimental drug called vonapanitase (PRT-201) in patients both receiving or expecting to receive hemodialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. Vonapanitase 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 vonapanitase 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.
Primary Outcome
Kaplan-Meier estimate of median time from AVF creation until AVF abandonment (secondary patency)
Interventions
- DRUG Placebo
- DRUG Vonapanitase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 696 participants |
| Start Date | 2015-08 |
| Est. Completion | 2019-05-01 |
| Phase | Phase 3 |
What the finished NCT02414841 record still lists
NCT02414841 is an interventional study that assigns participants to a tested intervention. The registered 696 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02414841 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02414841 about?
NCT02414841 is a clinical study titled "A Study of Vonapanitase (PRT-201) Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-2)". This research study is designed to assess the safety and effectiveness of an experimental drug called vonapanitase (PRT-201) in patients both receiving or expecting to receive hemodialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstrea...
What is the current status of trial NCT02414841?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 696 participants. The study started on 2015-08. Estimated completion is 2019-05-01.
What interventions are being tested in trial NCT02414841?
The interventions under investigation include: Placebo (DRUG), Vonapanitase (DRUG).
Who is sponsoring clinical trial NCT02414841?
This trial is sponsored by Proteon Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02414841's enrollment target sits among peer trials
696 518th of 2000 higher than 1,483 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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