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A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease (PRT-201-102)

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 1
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 Chronic Kidney Disease, Arteriovenous Grafts (AVG), Hemodialysis, Vascular Access, Dialysis, Graft, Access, 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. Chronic kidney disease with anticipated start of hemodialysis within 3 months or current hemodialysis dependence.
  3. Planned creation of a new upper extremity AVG or "jump" graft

Exclusion Criteria:

  1. Patients for whom this is the only potential site for an upper extremity vascular access.
  2. Creation of a new AVG or "jump" graft in an upper extremity previously treated with an investigational gene or cell based therapy, or locally with an investigational pharmacological agent.
  3. On physical examination or by other means, suspected proximal vein stenosis, occlusion, lack of continuity with the subclavian vein, central venous stenosis or central venous occlusion.
  4. History or presence of an arterial aneurysm.
  5. Previous treatment with PRT-201.

Sites / Locations

  • Ladenheim Dialysis Access Center
  • California Institute of Renal Research
  • Washington Hospital/Medstar Research
  • Indiana/Ohio Heart
  • Indiana University/Purdue University
  • University of Louisville
  • Vascular Specialty Center
  • Brigham & Women's Hospital
  • University of Massachusetts
  • Weill Cornell Medical College
  • Duke University Medical Center
  • University of Cincinnati
  • Greenville Memorial Hospital
  • The Methodist Hospital
  • Peripheral Vascular Associates
  • Sentara Vascular Specialists

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

PRT-201

Arm Description

Outcomes

Primary Outcome Measures

To assess the safety of a single topical dose of PRT-201.

Secondary Outcome Measures

Primary graft patency
Secondary graft patency.

Full Information

First Posted
October 22, 2009
Last Updated
April 8, 2015
Sponsor
Proteon Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01001351
Brief Title
A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease
Acronym
PRT-201-102
Official Title
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Graft 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
September 2009 (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
PRT-201 is a recombinant human type-I pancreatic elastase intended for local, long-lasting dilation of the AVG venous anastomosis and outflow vein. The goal of the treatment is to improve primary patency and long-term survival of AVGs and thereby provide patients with chronic kidney disease (CKD) a reliable and durable vascular access site for hemodialysis. Recent data indicate that up to three quarters of patients have loss of graft patency at one year, indicating a substantial need for new therapies. This clinical trial will explore the safety and dilatory effect of topically administered PRT-201 on the outflow vein of a newly placed upper extremity AVG.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Chronic Kidney Disease, Arteriovenous Grafts (AVG), Hemodialysis, Vascular Access, Dialysis, Graft, Access, vonapanitase, kidney, renal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
PRT-201
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PRT-201
Intervention Description
Applied topically during surgery.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Applied topically during surgery
Primary Outcome Measure Information:
Title
To assess the safety of a single topical dose of PRT-201.
Time Frame
Day of AVG creation and 4 weeks After surgery.
Secondary Outcome Measure Information:
Title
Primary graft patency
Time Frame
3, 6, 9 and 12 months after AVG creation.
Title
Secondary graft patency.
Time Frame
3, 6, 9 and 12 months after AVG 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. Chronic kidney disease with anticipated start of hemodialysis within 3 months or current hemodialysis dependence. Planned creation of a new upper extremity AVG or "jump" graft Exclusion Criteria: Patients for whom this is the only potential site for an upper extremity vascular access. Creation of a new AVG or "jump" graft in an upper extremity previously treated with an investigational gene or cell based therapy, or locally with an investigational pharmacological agent. On physical examination or by other means, suspected proximal vein stenosis, occlusion, lack of continuity with the subclavian vein, central venous stenosis or central venous occlusion. History or presence of an arterial aneurysm. Previous treatment with PRT-201.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Wong, MD, PhD
Organizational Affiliation
Proteon Therapeutics, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Ladenheim Dialysis Access Center
City
Fresno
State/Province
California
ZIP/Postal Code
93710
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
Washington Hospital/Medstar Research
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Indiana/Ohio Heart
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Indiana University/Purdue University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Vascular Specialty Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
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
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Peripheral Vascular Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Sentara Vascular Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24811601
Citation
Dwivedi AJ, Roy-Chaudhury P, Peden EK, Browne BJ, Ladenheim ED, Scavo VA, Gustafson PN, Wong MD, Magill M, Lindow F, Blair AT, Jaff MR, Franano FN, Burke SK. Application of human type I pancreatic elastase (PRT-201) to the venous anastomosis of arteriovenous grafts in patients with chronic kidney disease. J Vasc Access. 2014 Sep-Oct;15(5):376-84. doi: 10.5301/jva.5000235. Epub 2014 May 3.
Results Reference
result
PubMed Identifier
34298589
Citation
Mohamed I, Kamarizan MFA, Da Silva A. Medical adjuvant treatment to increase patency of arteriovenous fistulae and grafts. Cochrane Database Syst Rev. 2021 Jul 23;7(7):CD002786. doi: 10.1002/14651858.CD002786.pub4.
Results Reference
derived

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A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease

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