A Study of Vonapanitase (PRT-201) Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-2)

July 20, 2019 updated by: Proteon Therapeutics

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

This research study is designed to assess the safety and effectiveness of an experimental drug called vonapanitase (PRT-201) in patients both receiving or expecting to receive hemodialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. Vonapanitase 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 vonapanitase 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

696

Phase

  • Phase 3

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2B7
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Science Center
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network Toronto General Hospital
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre- Royal Victoria Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • AKDHC Medical Research Services, LLC
      • Tucson, Arizona, United States, 85724
        • Banner University Medical Center Tucson
      • Tucson, Arizona, United States, 85745
        • AKDHC Medical Research Services, LLC
    • California
      • Loma Linda, California, United States, 92357
        • VA Loma Linda Healthcare System
      • Long Beach, California, United States, 90822
        • VA Medical Center Long Beach
      • Los Angeles, California, United States, 90033
        • Keck University Hospital at USC
      • San Diego, California, United States, 92123
        • California Institute of Renal Research
      • San Diego, California, United States, 92120
        • Kaiser Permanente
      • San Francisco, California, United States, 94118
        • Kaiser Permanente Northern California
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Peoria, Illinois, United States, 61603
        • RenalCare Associates, S.C.
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Lutheran Hospital Network of Indiana
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • The University of Iowa Hospitals and Clinics
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • VA Ann Arbor Healthcare System
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Mississippi
      • Greenwood, Mississippi, United States, 38930
        • Greenwood Leflore Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital
    • New York
      • New York, New York, United States, 10065
        • New York Presbyterian Hospital-Weill Cornell Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Health Network
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburg Healthcare System
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • SC Nephrology and Hypertension Center, Inc.
    • Tennessee
      • Knoxville, Tennessee, United States, 37923
        • Knoxville Kidney Center
    • Texas
      • Austin, Texas, United States, 78756
        • Cardiothoracis and Vascular Surgeons
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Washington
      • Bellevue, Washington, United States, 98004
        • Lake Washington Vascular Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin School of Medicine and PH

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 to 100 years (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. Diagnosis of CKD.
  4. Planned creation of a new radiocephalic AVF (revision of an existing AVF is not eligible).
  5. Ability to understand and comply with the requirements of the entire study and to communicate with the study team.
  6. Written informed consent using a document that has been approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
  7. If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the screening visit and be willing to use contraception from the time of the screening visit to 2 weeks following study drug administration. Acceptable methods of birth control include abstinence, barrier methods, hormones, or intra-uterine device.

Exclusion Criteria:

  1. 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 or squamous cell skin cancer, or any cancer in situ.
  2. Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study.
  3. Previous treatment with vonapanitase (PRT-201).
  4. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within the previous 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
Active Comparator: Vonapanitase
Vonapanitase administered at the time of radiocephalic fistula creation
Drug: Vonapanitase
Other Names:
  • PRT-201
Placebo Comparator: Placebo
Placebo administered at the time of radiocephalic fistula creation
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kaplan-Meier Estimate of Secondary AVF Patency
Time Frame: Median time from AVF creation to AVF abandonment (secondary patency), assessed up to 1 year.
Kaplan-Meier estimate of median time from AVF creation until AVF abandonment (secondary patency)
Median time from AVF creation to AVF abandonment (secondary patency), assessed up to 1 year.
Number of Participants With AVF Use for Hemodialysis
Time Frame: Assessed at up to 12 Months
AVF use for hemodialysis is defined as the ability of the study AVF to be successfully cannulated and used for hemodialysis for a minimum of 90 days or at least 30 days prior to a patient's last visit, if hemodialysis has not been initiated at least 90 days prior to the patient's last visit. If AVF use is not defined as above, non-use of the AVF for hemodialysis is defined as an abandoned fistula prior to use; or if hemodialysis is recorded on 2 consecutive visits and there is no cannulation date or duration of use is less than 90 days. The patients who are not categorized as having use or non-use of the AVF have insufficient data to determine AVF use for hemodialysis and will be categorized as having indeterminate use.
Assessed at up to 12 Months

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 (Actual)

August 1, 2015

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

April 10, 2015

First Posted (Estimate)

April 13, 2015

Study Record Updates

Last Update Posted (Actual)

August 13, 2019

Last Update Submitted That Met QC Criteria

July 20, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRT-201-320

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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