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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 is a Phase 3 study that has completed, run by Proteon Therapeutics. The registered enrollment target is 349 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG PRT-201

Trial Details

FieldValue
Enrollment Target 349 participants
Start Date 2014-07
Est. Completion 2018-12
Phase Phase 3

Sponsor

Proteon Therapeutics

7 total trials

What the Registry Record Tells You About NCT02110901

The ClinicalTrials.gov registry entry for NCT02110901 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 349 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Proteon Therapeutics, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02110901 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.