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

This study is currently recruiting participants.
Verified October 2017 by Proteon Therapeutics
Sponsor:
ClinicalTrials.gov Identifier:
NCT02414841
First Posted: April 13, 2015
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Proteon Therapeutics
  Purpose
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.

Condition Intervention Phase
Chronic Kidney Disease Drug: vonapanitase Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Double Blind, Placebo Controlled Study of Vonapanitase (PRT- 201) Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Proteon Therapeutics:

Primary Outcome Measures:
  • Co-primary endpoints of secondary patency and AVF use for hemodialysis [ Time Frame: 12 months ]
    Secondary patency is defined as the time from AVF creation until AVF abandonment. 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.


Other Outcome Measures:
  • Unassisted AVF use for hemodialysis [ Time Frame: 12 months ]
    Unassisted AVF use for hemodialysis is defined as AVF use without prior procedures to restore or maintain patency.

  • Primary unassisted patency [ Time Frame: 12 months ]
    Primary unassisted patency is defined as the time from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain AVF patency.

  • Maturation [ Time Frame: 3 months ]

    Maturation by ultrasound criteria is defined by two definitions:

    1. As average cephalic vein luminal diameter ≥ 6 mm and outflow vein volume blood flow ≥ 600 mL/min by ultrasound.
    2. As average cephalic vein luminal diameter ≥ 4 mm and outflow vein volume blood flow ≥ 500 mL/min by ultrasound.

  • Procedure rate [ Time Frame: 12 months ]
    The procedure rate is defined as the total number of procedure days divided by time on study per person year of follow up.


Estimated Enrollment: 600
Actual Study Start Date: August 2015
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vonapanitase
Vonapanitase administered at the time of radiocephalic fistula creation
Drug: vonapanitase
Other Name: PRT-201
Placebo Comparator: Placebo
Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition of vonapanitase but lacks the active ingredient.
Drug: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414841


Contacts
Contact: Francesca Lindow 781-890-0102 ext 1028 FMLindow@proteontherapeutics.com

  Show 41 Study Locations
Sponsors and Collaborators
Proteon Therapeutics
  More Information

Responsible Party: Proteon Therapeutics
ClinicalTrials.gov Identifier: NCT02414841     History of Changes
Other Study ID Numbers: PRT-201-320
First Submitted: April 8, 2015
First Posted: April 13, 2015
Last Update Posted: October 23, 2017
Last Verified: October 2017

Keywords provided by Proteon Therapeutics:
radiocephalic
arteriovenous fistula
AVF
hemodialysis
PRT-201
vonapanitase
vascular access
kidney
renal
PATENCY-2
secondary patency
fistula abandonment
use for hemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Fistula
Arteriovenous Fistula
Urologic Diseases
Renal Insufficiency
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities