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

April 8, 2015 updated by: Proteon Therapeutics

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age of at least 18 years.
  2. Life expectancy of at least 6 months.
  3. Chronic kidney disease on hemodialysis, or with anticipated start of hemodialysis within 6 months.
  4. Planned creation of a new radiocephalic or brachiocephalic AVF. Revisions of an existing AVF and transposed AVF are not acceptable.

Exclusion Criteria:

  1. History or presence of an arterial aneurysm.
  2. Malignancy or treatment for malignancy within the previous 12 months with the exception of the following cancers if they have been resected: localized basal cell cancer, squamous cell skin cancer, or any cancer in situ.
  3. Hepatic dysfunction defined as bilirubin, ALT [SGPT] or AST [SGOT] >2.5 times the upper limit of normal, decompensated cirrhosis, ascites, or known esophageal or gastric varices.
  4. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo administered at the time of AVF creation.
Active Comparator: PRT 201 (10 micrograms)
Drug: PRT-201
PRT-201 10 micrograms administered at the time of AVF creation.
Drug: PRT-201
PRT-201 30 micrograms administered at the time of AVF creation.
Active Comparator: PRT-201 (30 micrograms)
Drug: PRT-201
PRT-201 10 micrograms administered at the time of AVF creation.
Drug: PRT-201
PRT-201 30 micrograms administered at the time of AVF creation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary AVF patency.
Time Frame: 12 months after AVF creation
12 months after AVF creation
Number of participants with adverse events as a measure of safety and tolerability of PRT-201.
Time Frame: 12 months after AVF creation.
12 months after AVF creation.

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary Fistula Patency
Time Frame: 12 months after AVF creation
12 months after AVF creation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Proteon Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

February 25, 2011

First Posted (Estimate)

March 1, 2011

Study Record Updates

Last Update Posted (Estimate)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRT-201-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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