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Completed Phase 1Phase 2 Interventional

A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients

ClinicalTrials.gov ID: NCT00679991

Public ClinicalTrials.gov record NCT00679991. 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 Sep 1, 2026, 3:28 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

A Phase 1-2, Multi-Center, Dose Escalation Study of a Single Dose 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.

PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel. The purpose of this study is to determine if PRT-201, when applied to a limited segment of blood vessel immediately after surgery to create an arteriovenous fistula (AVF), is safe, dilates the blood vessel, and increases blood flow through the AVF.

Study identification

NCT ID
NCT00679991
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Proteon Therapeutics
Industry
Enrollment
66 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
Oct 31, 2008
Primary completion
Jun 30, 2011
Completion
Jun 30, 2011
Last update posted
Apr 29, 2015

2008 – 2011

United States locations

U.S. sites
11
U.S. states
10
U.S. cities
11
Facility City State ZIP Site status
Clarian Health Partners/Indiana University/Purdue University Indianapolis Indiana 46202
University of Iowa Hospitals and Clinics Iowa City Iowa 52242
Maine Medical Center Portland Maine 04102
Brigham and Women's Hospital Boston Massachusetts 02115
Western New England Renal & Transplant Associates Springfield Massachusetts 01104
Washington University in St. Louis St Louis Missouri 63110
Weill Cornell Medical College New York New York 10065
Duke University Medical Center Durham North Carolina 27710
University of Cincinnati Medical Center Cincinnati Ohio 45267
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 NCT00679991, 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 29, 2015 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00679991 live on ClinicalTrials.gov.

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