A Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
1 other identifier
interventional
151
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2011
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2011
CompletedFirst Posted
Study publicly available on registry
March 1, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedApril 30, 2015
April 1, 2015
1.7 years
February 16, 2011
April 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary AVF patency.
12 months after AVF creation
Number of participants with adverse events as a measure of safety and tolerability of PRT-201.
12 months after AVF creation.
Secondary Outcomes (1)
Secondary Fistula Patency
12 months after AVF creation
Study Arms (3)
PRT 201 (10 micrograms)
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORPRT-201 (30 micrograms)
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
California Institute of Renal Research
San Diego, California, 92123, United States
Kaiser Permanente
San Diego, California, United States
UCSF
San Francisco, California, United States
Rush Medical Center
Chicago, Illinois, United States
Renal Care Associates
Peoria, Illinois, United States
Indiana Ohio Heart
Fort Wayne, Indiana, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Louisville
Louisville, Kentucky, United States
Vascular Specialty Center
Baton Rouge, Louisiana, United States
Beth Israel Deconness Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
UMASS Medical Center
Worcester, Massachusetts, United States
St Clair Specialty Physicians
Detroit, Michigan, United States
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Legacy Oregon Surgical
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Sentara Medical Group
Norfolk, Virginia, 23507, United States
Related Publications (1)
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.
PMID: 24684771RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2011
First Posted
March 1, 2011
Study Start
March 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
April 30, 2015
Record last verified: 2015-04