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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PRT-201
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, vascular access, kidney, renal, vonapanitase, PATENCY-1

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 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.

Sites / Locations

  • University of Alabama at Birmingham
  • AKDHC Medical Research Services , LLC
  • AKDHC Medical Research Services, LLc
  • Alliance Research Center
  • VA Medical Center Long Beach
  • Keck University Hospital at USC
  • Kaiser Permanente Medical Center
  • California Institute of Renal Research
  • UCSF Division of Vascular & Endovascular Surgery
  • Rush Medical Center
  • Renal Care Associates
  • Lutheran Hospital Network of Indiana
  • University of Iowa Hospitals and Clinics
  • University of Louisville
  • Tulane University
  • Louisiana State University Health Sciences Center
  • Maine Medical Center
  • University of Maryland
  • University of Maryland Shore Medical Center at Easton
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • University of Massachusetts Medical Center
  • Mount Sinai Medical Center
  • University of North Carolina at Chapel Hill
  • Duke University
  • W.G. Hefner VA Medical Center
  • Wake Forest
  • University of Cincinnati Medical Center
  • University of Cincinnati
  • Ohio State University
  • The University of Oklahoma College of Medicine
  • Lehigh Valley Health Network
  • VA Pittsburg Healthcare System
  • The Methodist Hospital
  • Lake Washington Vascular Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

PRT-201

Placebo

Arm Description

PRT-201 administered at the time of radiocephalic fistula creation

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.

Outcomes

Primary Outcome Measures

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.
Kaplan-Meier Estimate of Secondary AVF Patency
Kaplan-Meier Estimate of median time from AVF creation until AVF abandonment (secondary patency)

Secondary Outcome Measures

Full Information

First Posted
April 2, 2014
Last Updated
June 17, 2019
Sponsor
Proteon Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02110901
Brief Title
A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)
Official Title
Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2018 (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 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.

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, vascular access, kidney, renal, vonapanitase, PATENCY-1

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
PRT-201
Arm Type
Active Comparator
Arm Description
PRT-201 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. The placebo is identical in appearance and composition to PRT-201 but lacks the active ingredient.
Intervention Type
Drug
Intervention Name(s)
PRT-201
Other Intervention Name(s)
vonapanitase
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Time to AVF Primary Unassisted Patency
Description
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.
Time Frame
Days from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency, assessed up to 1 year
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 until AVF abandonment (secondary patency), assessed up to 1 year
Other Pre-specified Outcome Measures:
Title
Number of Participants With Unassisted AVF Maturation by Ultrasound
Description
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.
Time Frame
Assessed 3 months after AVF creation
Title
Number of Participants With Unassisted AVF Use for Hemodialysis
Description
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.
Time Frame
Assessed at 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 Chronic Kidney Disease (CKD). Planned creation of a new radiocephalic arteriovenous fistula (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). 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: 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 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
AKDHC Medical Research Services, LLc
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Alliance Research Center
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
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 Medical Center
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
UCSF Division of Vascular & Endovascular Surgery
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Rush Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Renal Care Associates
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
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
Louisiana State University Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Maryland Shore Medical Center at Easton
City
Easton
State/Province
Maryland
ZIP/Postal Code
21601
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02482
Country
United States
Facility Name
University of Massachusetts Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
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
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
W.G. Hefner VA Medical Center
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Wake Forest
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The University of Oklahoma College of Medicine
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
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
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
30683197
Citation
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.
Results Reference
derived

Learn more about this trial

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

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