A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)

Multicenter, Double-Blind, Placebo-Controlled Study of 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 PRT-201 in patients both receiving or expecting to receive dialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. PRT-201 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 PRT-201 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: Chronic Kidney Disease
• Intervention / Treatment: Drug: Placebo; Drug: PRT-201

• Study Type: Interventional
• Enrollment (Actual): 349
• Phase: Phase 3

Contacts and Locations

Study Locations

• 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, 85719
      • AKDHC Medical Research Services, LLC
  • California
    • Laguna Hills, California, United States, 92653
      • Alliance Research Center
    • 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 Medical Center
    • San Francisco, California, United States, 94143
      • UCSF Division of Vascular & Endovascular Surgery
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush Medical Center
    • Peoria, Illinois, United States, 61603
      • Renal Care Associates
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Lutheran Hospital Network of Indiana
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University
    • Shreveport, Louisiana, United States, 71130
      • Louisiana State University Health Sciences Center
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
    • Easton, Maryland, United States, 21601
      • University of Maryland Shore Medical Center at Easton
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02482
      • Brigham and Women's Hospital
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical Center
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina At Chapel Hill
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Salisbury, North Carolina, United States, 28144
      • W.G. Hefner VA Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati Medical Center
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • The University of Oklahoma College of Medicine
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health Network
    • Pittsburgh, Pennsylvania, United States, 15240
      • VA Pittsburg Healthcare System
  • Texas
    • Houston, Texas, United States, 77030
      • The Methodist Hospital
  • Washington
    • Bellevue, Washington, United States, 98004
      • Lake Washington Vascular Center

Participation Criteria

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 Chronic Kidney Disease (CKD).
4. Planned creation of a new radiocephalic arteriovenous fistula (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).
7. If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the screening visit (Visit 1) 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 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PRT-201; PRT-201 administered at the time of radiocephalic fistula creation	Drug: PRT-201; Other Names: vonapanitase
Placebo Comparator: Placebo; Placebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition to PRT-201 but lacks the active ingredient.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to AVF Primary Unassisted Patency	Primary unassisted patency defined as the time from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency.	Days from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency, assessed up to 1 year
Kaplan-Meier Estimate of Secondary AVF Patency	Kaplan-Meier Estimate of median time from AVF creation until AVF abandonment (secondary patency)	Median time from AVF creation until AVF abandonment (secondary patency), assessed up to 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Unassisted AVF Maturation by Ultrasound	AVF maturation is defined as average cephalic vein lumen diameter >= 4 mm and an outflow vein volume blood flow >= 500 mL/min by ultrasound without prior primary unassisted patency loss.	Assessed 3 months after AVF creation
Number of Participants With Unassisted AVF Use for Hemodialysis	Unassisted AVF use for hemodialysis is defined as continuous use of the AVF for hemodialysis without prior primary unassisted patency loss. Use of the AVF 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 was not initiated at least 90 days prior to the last visit. 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 by the rules described above have insufficient data to determine use for hemodialysis and will be categorized as having indeterminate use.	Assessed at 12 months

Collaborators and Investigators

• Sponsor: Proteon Therapeutics

Publications and helpful links

General Publications

• Bleyer AJ, Scavo VA, Wilson SE, Browne BJ, Ferris BL, Ozaki CK, Lee T, Peden EK, Dixon BS, Mishler R, O'Connor TP, Kidd K, Burke SK; PATENCY-1 Investigators. A randomized trial of vonapanitase (PATENCY-1) to promote radiocephalic fistula patency and use for hemodialysis. J Vasc Surg. 2019 Feb;69(2):507-515. doi: 10.1016/j.jvs.2018.04.068. Erratum In: J Vasc Surg. 2019 Apr;69(4):1329.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: April 2, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: renal; kidney; hemodialysis; arteriovenous fistula; AVF; vascular access; vonapanitase; PRT-201; radiocephalic; PATENCY-1
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Congenital Abnormalities; Renal Insufficiency; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Kidney Diseases; Renal Insufficiency, Chronic; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: PRT-201-310