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Completed Phase 2 Interventional

A Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

ClinicalTrials.gov ID: NCT01305824

Public ClinicalTrials.gov record NCT01305824. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 11:44 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to determine if PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous fistula is safe and improves the patency of your fistula. PRT-201 is a protein that has been shown to help keep vessels open ("patent") when applied to the outside surface of the blood vessels (arteries and veins) in AVF patients in a previous study.

Study identification

NCT ID
NCT01305824
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Proteon Therapeutics
Industry
Enrollment
151 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2011 (Type not available)
Primary completion
Nov 2012 (Actual)
Completion
Nov 2012 (Actual)
Last update posted
Apr 30, 2015

2011 – 2012

United States locations

U.S. sites
23
U.S. states
15
U.S. cities
21
Facility City State ZIP Site status
California Institute of Renal Research San Diego California 92123 —
Kaiser Permanente San Diego California — —
UCSF San Francisco California — —
Rush Medical Center Chicago Illinois — —
Renal Care Associates Peoria Illinois — —
Indiana Ohio Heart Fort Wayne Indiana — —
Indiana University Indianapolis Indiana 46202 —
University of Iowa Iowa City Iowa 52242 —
University of Louisville Louisville Kentucky — —
Vascular Specialty Center Baton Rouge Louisiana — —
Beth Israel Deconness Hospital Boston Massachusetts — —
Brigham and Women's Hospital Boston Massachusetts — —
UMASS Medical Center Worcester Massachusetts — —
St Clair Specialty Physicians Detroit Michigan — —
Thoracic & Cardiovascular Healthcare Foundation Lansing Michigan — —
Weill Cornell Medical College New York New York 10065 —
Montefiore Medical Center The Bronx New York — —
Duke University Medical Center Durham North Carolina 27710 —
Legacy Oregon Surgical Portland Oregon — —
Lehigh Valley Hospital Allentown Pennsylvania — —
Vanderbilt University Medical Center Nashville Tennessee 37232 —
The Methodist Hospital Houston Texas 77030 —
Sentara Medical Group Norfolk Virginia 23507 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01305824, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 30, 2015 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01305824 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →