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A Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PRT-201
Placebo
PRT-201
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 arteriovenous fistula, AVF, hemodialysis, vascular access, dialysis, fistula, PRT-201, vonapanitase, kidney, renal

Eligibility Criteria

18 Years - undefined (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. Chronic kidney disease on hemodialysis, or with anticipated start of hemodialysis within 6 months.
  4. Planned creation of a new radiocephalic or brachiocephalic AVF. Revisions of an existing AVF and transposed AVF are not acceptable.

Exclusion Criteria:

  1. History or presence of an arterial aneurysm.
  2. 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 cancer, squamous cell skin cancer, or any cancer in situ.
  3. Hepatic dysfunction defined as bilirubin, ALT [SGPT] or AST [SGOT] >2.5 times the upper limit of normal, decompensated cirrhosis, ascites, or known esophageal or gastric varices.
  4. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.

Sites / Locations

  • California Institute of Renal Research
  • Kaiser Permanente
  • UCSF
  • Rush Medical Center
  • Renal Care Associates
  • Indiana Ohio Heart
  • Indiana University
  • University of Iowa
  • University of Louisville
  • Vascular Specialty Center
  • Beth Israel Deconness Hospital
  • Brigham and Women's Hospital
  • UMASS Medical Center
  • St Clair Specialty Physicians
  • Thoracic & Cardiovascular Healthcare Foundation
  • Montefiore Medical Center
  • Weill Cornell Medical College
  • Duke University Medical Center
  • Legacy Oregon Surgical
  • Lehigh Valley Hospital
  • Vanderbilt University Medical Center
  • The Methodist Hospital
  • Sentara Medical Group

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

PRT 201 (10 micrograms)

Placebo

PRT-201 (30 micrograms)

Arm Description

Outcomes

Primary Outcome Measures

Primary AVF patency.
Number of participants with adverse events as a measure of safety and tolerability of PRT-201.

Secondary Outcome Measures

Secondary Fistula Patency

Full Information

First Posted
February 16, 2011
Last Updated
April 8, 2015
Sponsor
Proteon Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01305824
Brief Title
A Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Official Title
Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (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
The purpose of this study is to determine if PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous fistula is safe and improves the patency of your fistula. PRT-201 is a protein that has been shown to help keep vessels open ("patent") when applied to the outside surface of the blood vessels (arteries and veins) in AVF patients in a previous study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
arteriovenous fistula, AVF, hemodialysis, vascular access, dialysis, fistula, PRT-201, vonapanitase, kidney, renal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRT 201 (10 micrograms)
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
PRT-201 (30 micrograms)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
PRT-201
Intervention Description
PRT-201 10 micrograms administered at the time of AVF creation.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered at the time of AVF creation.
Intervention Type
Drug
Intervention Name(s)
PRT-201
Intervention Description
PRT-201 30 micrograms administered at the time of AVF creation.
Primary Outcome Measure Information:
Title
Primary AVF patency.
Time Frame
12 months after AVF creation
Title
Number of participants with adverse events as a measure of safety and tolerability of PRT-201.
Time Frame
12 months after AVF creation.
Secondary Outcome Measure Information:
Title
Secondary Fistula Patency
Time Frame
12 months after AVF creation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of at least 18 years. Life expectancy of at least 6 months. Chronic kidney disease on hemodialysis, or with anticipated start of hemodialysis within 6 months. Planned creation of a new radiocephalic or brachiocephalic AVF. Revisions of an existing AVF and transposed AVF are not acceptable. Exclusion Criteria: History or presence of an arterial aneurysm. 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 cancer, squamous cell skin cancer, or any cancer in situ. Hepatic dysfunction defined as bilirubin, ALT [SGPT] or AST [SGOT] >2.5 times the upper limit of normal, decompensated cirrhosis, ascites, or known esophageal or gastric varices. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.
Facility Information:
Facility Name
California Institute of Renal Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Kaiser Permanente
City
San Diego
State/Province
California
Country
United States
Facility Name
UCSF
City
San Francisco
State/Province
California
Country
United States
Facility Name
Rush Medical Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Renal Care Associates
City
Peoria
State/Province
Illinois
Country
United States
Facility Name
Indiana Ohio Heart
City
Fort Wayne
State/Province
Indiana
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Vascular Specialty Center
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Beth Israel Deconness Hospital
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
UMASS Medical Center
City
Worcester
State/Province
Massachusetts
Country
United States
Facility Name
St Clair Specialty Physicians
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Thoracic & Cardiovascular Healthcare Foundation
City
Lansing
State/Province
Michigan
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Legacy Oregon Surgical
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sentara Medical Group
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24684771
Citation
Hye RJ, Peden EK, O'Connor TP, Browne BJ, Dixon BS, Schanzer AS, Jensik SC, Dember LM, Jaff MR, Burke SK. Human type I pancreatic elastase treatment of arteriovenous fistulas in patients with chronic kidney disease. J Vasc Surg. 2014 Aug;60(2):454-461.e1. doi: 10.1016/j.jvs.2014.02.037. Epub 2014 Mar 27.
Results Reference
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A Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

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