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NCT02110901 · ClinicalTrials.gov registry record · Phase 3
A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)
A Phase 3 study, sponsored by Proteon Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 349
- Enrollment target
NCT02110901: Completed Phase 3 study, sponsored by Proteon Therapeutics.
NCT02110901 is a Phase 3 study that has completed, run by Proteon Therapeutics. The registered enrollment target is 349 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02110901, a Phase 3 study, has completed, sponsored by Proteon Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 349 participants
- Enrollment target
Study 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.
Primary Outcome
Primary unassisted patency defined as the time from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency.
Interventions
- DRUG Placebo
- DRUG PRT-201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 349 participants |
| Start Date | 2014-07 |
| Est. Completion | 2018-12 |
| Phase | Phase 3 |
What the finished NCT02110901 record still lists
NCT02110901 is an interventional study that assigns participants to a tested intervention. The registered 349 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 (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02110901 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02110901 about?
NCT02110901 is a clinical study titled "A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)". 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....
What is the current status of trial NCT02110901?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 349 participants. The study started on 2014-07. Estimated completion is 2018-12.
What interventions are being tested in trial NCT02110901?
The interventions under investigation include: Placebo (DRUG), PRT-201 (DRUG).
Who is sponsoring clinical trial NCT02110901?
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 NCT02110901's enrollment target sits among peer trials
349 1045th of 2000 higher than 956 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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