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A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PRT-201
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, PRT 201, dose escalation, dialysis, fistula, access, vonapanitase, kidney, renal

Eligibility Criteria

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

Inclusion Criteria:

  • Age of at least 18 years.
  • Chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence.
  • Planned creation of a new AVF.

Exclusion Criteria:

  • Patients for whom this is the only potential site for an AVF.
  • By physical examination, absence of radial or ulnar artery flow or non-patent palmer arch.
  • Treatment with any investigational agent within the previous 30 days or investigational antibody therapy within 90 days of signing informed consent.
  • Pregnancy, lactation or plans to become pregnant during the course of the study.

Sites / Locations

  • Clarian Health Partners/Indiana University/Purdue University
  • University of Iowa Hospitals and Clinics
  • Maine Medical Center
  • Brigham and Women's Hospital
  • Western New England Renal & Transplant Associates
  • Washington University in St. Louis
  • Weill Cornell Medical College
  • Duke University Medical Center
  • University of Cincinnati Medical Center
  • The Methodist Hospital
  • Sentara Medical Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

PRT-201

2

Arm Description

Outcomes

Primary Outcome Measures

To assess the safety of a single topical dose of PRT-201. To assess the effect on the diameter of and blood flow through the AVF outflow vein.

Secondary Outcome Measures

The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis.

Full Information

First Posted
May 15, 2008
Last Updated
April 8, 2015
Sponsor
Proteon Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00679991
Brief Title
A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients
Official Title
A Phase 1-2, Multi-Center, Dose Escalation Study of a Single Dose 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
November 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (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 protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel. The purpose of this study is to determine if PRT-201, when applied to a limited segment of blood vessel immediately after surgery to create an arteriovenous fistula (AVF), is safe, dilates the blood vessel, and increases blood flow through the AVF.

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, PRT 201, dose escalation, dialysis, fistula, access, vonapanitase, kidney, renal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRT-201
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PRT-201
Intervention Description
Applied topically to AVF during surgery
Intervention Type
Drug
Intervention Name(s)
PRT-201
Intervention Description
Dose escalation study. Drug/placebo administered at the time of fistula creation
Primary Outcome Measure Information:
Title
To assess the safety of a single topical dose of PRT-201. To assess the effect on the diameter of and blood flow through the AVF outflow vein.
Time Frame
2 & 6 weeks after AVF creation
Secondary Outcome Measure Information:
Title
The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis.
Time Frame
3, 6, 9, and 12 months

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 six months or current hemodialysis dependence. Planned creation of a new AVF. Exclusion Criteria: Patients for whom this is the only potential site for an AVF. By physical examination, absence of radial or ulnar artery flow or non-patent palmer arch. Treatment with any investigational agent within the previous 30 days or investigational antibody therapy within 90 days of signing informed consent. Pregnancy, lactation or plans to become pregnant during the course of the study.
Facility Information:
Facility Name
Clarian Health Partners/Indiana University/Purdue University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
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
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
Western New England Renal & Transplant Associates
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Facility Name
Washington University in St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
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 Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
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
23172172
Citation
Peden EK, Leeser DB, Dixon BS, El-Khatib MT, Roy-Chaudhury P, Lawson JH, Menard MT, Dember LM, Glickman MH, Gustafson PN, Blair AT, Magill M, Franano FN, Burke SK. A multi-center, dose-escalation study of human type I pancreatic elastase (PRT-201) administered after arteriovenous fistula creation. J Vasc Access. 2013 Apr-Jun;14(2):143-51. doi: 10.5301/jva.5000125. Epub 2012 Nov 20.
Results Reference
result

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A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients

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