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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)

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vonapanitase
Placebo
Sponsored by
Proteon Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring radiocephalic, arteriovenous fistula, AVF, hemodialysis, PRT-201, vonapanitase, vascular access, kidney, renal, PATENCY-2, secondary patency, fistula abandonment, use for hemodialysis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • AKDHC Medical Research Services, LLC
  • Banner University Medical Center Tucson
  • AKDHC Medical Research Services, LLc
  • VA Loma Linda Healthcare System
  • VA Medical Center Long Beach
  • Keck University Hospital at USC
  • Kaiser Permanente
  • California Institute of Renal Research
  • Kaiser Permanente Northern California
  • University of Chicago
  • RenalCare Associates, S.C.
  • Lutheran Hospital Network of Indiana
  • The University of Iowa Hospitals and Clinics
  • University of Louisville
  • Tulane University
  • Maine Medical Center
  • Brigham and Women's Hospital
  • University of Massachusetts Medical Center
  • VA Ann Arbor Healthcare System
  • Henry Ford Hospital
  • Greenwood Leflore Hospital
  • Saint Luke's Hospital
  • New York Presbyterian Hospital-Weill Cornell Medical Center
  • University of North Carolina at Chapel Hill
  • Wake Forest
  • Cleveland Clinic
  • Lehigh Valley Health Network
  • VA Pittsburg Healthcare System
  • SC Nephrology and Hypertension Center, Inc.
  • Knoxville Kidney Center
  • Cardiothoracis and Vascular Surgeons
  • Baylor College of Medicine
  • The Methodist Hospital
  • Lake Washington Vascular Center
  • University of Wisconsin School of Medicine and PH
  • University of Alberta
  • Vancouver General Hospital
  • London Health Science Center
  • University Health Network Toronto General Hospital
  • McGill University Health Centre- Royal Victoria Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vonapanitase

Placebo

Arm Description

Vonapanitase administered at the time of radiocephalic fistula creation

Placebo administered at the time of radiocephalic fistula creation

Outcomes

Primary Outcome Measures

Kaplan-Meier Estimate of Secondary AVF Patency
Kaplan-Meier estimate of median time from AVF creation until AVF abandonment (secondary patency)
Number of Participants With AVF Use for Hemodialysis
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.

Secondary Outcome Measures

Full Information

First Posted
April 8, 2015
Last Updated
July 20, 2019
Sponsor
Proteon Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02414841
Brief Title
A Study of Vonapanitase (PRT-201) Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-2)
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Proteon Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
radiocephalic, arteriovenous fistula, AVF, hemodialysis, PRT-201, vonapanitase, vascular access, kidney, renal, PATENCY-2, secondary patency, fistula abandonment, use for hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
696 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vonapanitase
Arm Type
Active Comparator
Arm Description
Vonapanitase administered at the time of radiocephalic fistula creation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered at the time of radiocephalic fistula creation
Intervention Type
Drug
Intervention Name(s)
Vonapanitase
Other Intervention Name(s)
PRT-201
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Kaplan-Meier Estimate of Secondary AVF Patency
Description
Kaplan-Meier estimate of median time from AVF creation until AVF abandonment (secondary patency)
Time Frame
Median time from AVF creation to AVF abandonment (secondary patency), assessed up to 1 year.
Title
Number of Participants With AVF Use for Hemodialysis
Description
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.
Time Frame
Assessed at up to 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of at least 18 years. Life expectancy of at least 6 months. Diagnosis of CKD. Planned creation of a new radiocephalic AVF (revision of an existing AVF is not eligible). Ability to understand and comply with the requirements of the entire study and to communicate with the study team. Written informed consent using a document that has been approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC). 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: 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. Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study. Previous treatment with vonapanitase (PRT-201). Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within the previous 90 days prior to signing informed consent.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
AKDHC Medical Research Services, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Banner University Medical Center Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
AKDHC Medical Research Services, LLc
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
VA Loma Linda Healthcare System
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Facility Name
VA Medical Center Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Keck University Hospital at USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Kaiser Permanente
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
California Institute of Renal Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Kaiser Permanente Northern California
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
RenalCare Associates, S.C.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Lutheran Hospital Network of Indiana
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
The University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Massachusetts Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
VA Ann Arbor Healthcare System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Greenwood Leflore Hospital
City
Greenwood
State/Province
Mississippi
ZIP/Postal Code
38930
Country
United States
Facility Name
Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
New York Presbyterian Hospital-Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Wake Forest
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
VA Pittsburg Healthcare System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
SC Nephrology and Hypertension Center, Inc.
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Knoxville Kidney Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Name
Cardiothoracis and Vascular Surgeons
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Lake Washington Vascular Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
University of Wisconsin School of Medicine and PH
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2B7
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
London Health Science Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
University Health Network Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
McGill University Health Centre- Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33482699
Citation
Peden EK, Lucas JF 3rd, Browne BJ, Settle SM, Scavo VA, Bleyer AJ, Ozaki CK, Teruya TH, Wilson SE, Mishler RE, Ferris BL, Hendon KS, Moist L, Dixon BS, Wong MD, Magill M, Lindow F, Gustafson P, Burke SK; PATENCY-2 Investigators. PATENCY-2 trial of vonapanitase to promote radiocephalic fistula use for hemodialysis and secondary patency. J Vasc Access. 2022 Mar;23(2):265-274. doi: 10.1177/1129729820985626. Epub 2021 Jan 22.
Results Reference
derived

Learn more about this trial

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

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