A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)
Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
1 other identifier
interventional
349
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2014
Typical duration for phase_3
35 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
April 2, 2014
CompletedFirst Posted
Study publicly available on registry
April 10, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedResults Posted
Study results publicly available
July 9, 2019
CompletedJuly 9, 2019
June 1, 2019
2.4 years
April 2, 2014
May 24, 2019
June 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Days from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency, assessed up to 1 year
Kaplan-Meier Estimate of Secondary AVF Patency
Kaplan-Meier Estimate of median time from AVF creation until AVF abandonment (secondary patency)
Median time from AVF creation until AVF abandonment (secondary patency), assessed up to 1 year
Other Outcomes (2)
Number of Participants With Unassisted AVF Maturation by Ultrasound
Assessed 3 months after AVF creation
Number of Participants With Unassisted AVF Use for Hemodialysis
Assessed at 12 months
Study Arms (2)
PRT-201
ACTIVE COMPARATORPRT-201 administered at the time of radiocephalic fistula creation
Placebo
PLACEBO COMPARATORPlacebo administered at the time of radiocephalic fistula creation. The placebo is identical in appearance and composition to PRT-201 but lacks the active ingredient.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
AKDHC Medical Research Services , LLC
Phoenix, Arizona, 85012, United States
AKDHC Medical Research Services, LLc
Tucson, Arizona, 85719, United States
Alliance Research Center
Laguna Hills, California, 92653, United States
VA Medical Center Long Beach
Long Beach, California, 90822, United States
Keck University Hospital at USC
Los Angeles, California, 90033, United States
Kaiser Permanente Medical Center
San Diego, California, 92120, United States
California Institute of Renal Research
San Diego, California, 92123, United States
UCSF Division of Vascular & Endovascular Surgery
San Francisco, California, 94143, United States
Rush Medical Center
Chicago, Illinois, 60612, United States
Renal Care Associates
Peoria, Illinois, 61603, United States
Lutheran Hospital Network of Indiana
Fort Wayne, Indiana, 46804, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Tulane University
New Orleans, Louisiana, 70112, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71130, United States
Maine Medical Center
Portland, Maine, 04102, United States
University of Maryland
Baltimore, Maryland, 21201, United States
University of Maryland Shore Medical Center at Easton
Easton, Maryland, 21601, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02482, United States
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University
Durham, North Carolina, 27710, United States
W.G. Hefner VA Medical Center
Salisbury, North Carolina, 28144, United States
Wake Forest
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Ohio State University
Columbus, Ohio, 43210, United States
The University of Oklahoma College of Medicine
Tulsa, Oklahoma, 74104, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
VA Pittsburg Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Lake Washington Vascular Center
Bellevue, Washington, 98004, United States
Related Publications (3)
Heindel P, Fitzgibbon JJ, Secemsky EA, Belkin M, Ozaki CK, Hussain MA. Evaluating the effectiveness of systemic heparin during arteriovenous fistula creation by emulating a target trial. Am J Epidemiol. 2025 Mar 4;194(3):651-658. doi: 10.1093/aje/kwae098.
PMID: 38825327DERIVEDHeindel P, Fitzgibbon JJ, Feliz JD, Hentschel DM, Burke SK, Al-Omran M, Bhatt DL, Belkin M, Ozaki CK, Hussain MA. Evaluating national guideline concordance of recurrent interventions after radiocephalic arteriovenous fistula creation. J Vasc Surg. 2023 Apr;77(4):1206-1215.e2. doi: 10.1016/j.jvs.2022.12.017. Epub 2022 Dec 22.
PMID: 36567000DERIVEDBleyer 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.
PMID: 30683197DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Steven Burke, MD
- Organization
- Proteon Therapeutics, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- 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
April 2, 2014
First Posted
April 10, 2014
Study Start
July 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2018
Last Updated
July 9, 2019
Results First Posted
July 9, 2019
Record last verified: 2019-06