A Study of Vonapanitase (PRT-201) Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-2)
Multicenter, Double Blind, Placebo Controlled Study of Vonapanitase (PRT- 201) Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
1 other identifier
interventional
696
2 countries
41
Brief Summary
This research study is designed to assess the safety and effectiveness of an experimental drug called vonapanitase (PRT-201) in patients both receiving or expecting to receive hemodialysis who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis. Vonapanitase 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 vonapanitase 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 P75+ for phase_3
Started Aug 2015
Typical duration for phase_3
41 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 8, 2015
CompletedFirst Posted
Study publicly available on registry
April 13, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedResults Posted
Study results publicly available
August 13, 2019
CompletedAugust 13, 2019
July 1, 2019
2.5 years
April 8, 2015
May 24, 2019
July 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 to AVF abandonment (secondary patency), assessed up to 1 year.
Number of Participants With AVF Use for Hemodialysis
AVF use for hemodialysis is defined as the ability of the study AVF to be successfully cannulated and used for hemodialysis for a minimum of 90 days or at least 30 days prior to a patient's last visit, if hemodialysis has not been initiated at least 90 days prior to the patient's last visit. If AVF use is not defined as above, non-use of the AVF for hemodialysis is defined as an abandoned fistula prior to use; or if hemodialysis is recorded on 2 consecutive visits and there is no cannulation date or duration of use is less than 90 days. The patients who are not categorized as having use or non-use of the AVF have insufficient data to determine AVF use for hemodialysis and will be categorized as having indeterminate use.
Assessed at up to 12 Months
Study Arms (2)
Vonapanitase
ACTIVE COMPARATORVonapanitase administered at the time of radiocephalic fistula creation
Placebo
PLACEBO COMPARATORPlacebo administered at the time of radiocephalic fistula creation
Interventions
Eligibility Criteria
You may qualify if:
- Age of at least 18 years.
- Life expectancy of at least 6 months.
- Diagnosis of CKD.
- Planned creation of a new radiocephalic 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) or Independent Ethics Committee (IEC).
- If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative serum pregnancy test at the screening visit 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 vonapanitase (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 (41)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
AKDHC Medical Research Services, LLC
Phoenix, Arizona, 85012, United States
Banner University Medical Center Tucson
Tucson, Arizona, 85724, United States
AKDHC Medical Research Services, LLc
Tucson, Arizona, 85745, United States
VA Loma Linda Healthcare System
Loma Linda, California, 92357, 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
San Diego, California, 92120, United States
California Institute of Renal Research
San Diego, California, 92123, United States
Kaiser Permanente Northern California
San Francisco, California, 94118, United States
University of Chicago
Chicago, Illinois, 60637, United States
RenalCare Associates, S.C.
Peoria, Illinois, 61603, United States
Lutheran Hospital Network of Indiana
Fort Wayne, Indiana, 46804, United States
The 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
Maine Medical Center
Portland, Maine, 04102, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655, United States
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Greenwood Leflore Hospital
Greenwood, Mississippi, 38930, United States
Saint Luke's Hospital
Kansas City, Missouri, 64111, United States
New York Presbyterian Hospital-Weill Cornell Medical Center
New York, New York, 10065, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Wake Forest
Winston-Salem, North Carolina, 27157, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
VA Pittsburg Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
SC Nephrology and Hypertension Center, Inc.
Orangeburg, South Carolina, 29118, United States
Knoxville Kidney Center
Knoxville, Tennessee, 37923, United States
Cardiothoracis and Vascular Surgeons
Austin, Texas, 78756, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Lake Washington Vascular Center
Bellevue, Washington, 98004, United States
University of Wisconsin School of Medicine and PH
Madison, Wisconsin, 53792, United States
University of Alberta
Edmonton, Alberta, T6G2B7, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
London Health Science Center
London, Ontario, N6A 5W9, Canada
University Health Network Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
McGill University Health Centre- Royal Victoria Hospital
Montreal, Quebec, H4A 3J1, Canada
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: 36567000DERIVEDPeden EK, Lucas JF 3rd, Browne BJ, Settle SM, Scavo VA, Bleyer AJ, Ozaki CK, Teruya TH, Wilson SE, Mishler RE, Ferris BL, Hendon KS, Moist L, Dixon BS, Wong MD, Magill M, Lindow F, Gustafson P, Burke SK; PATENCY-2 Investigators. PATENCY-2 trial of vonapanitase to promote radiocephalic fistula use for hemodialysis and secondary patency. J Vasc Access. 2022 Mar;23(2):265-274. doi: 10.1177/1129729820985626. Epub 2021 Jan 22.
PMID: 33482699DERIVED
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 8, 2015
First Posted
April 13, 2015
Study Start
August 1, 2015
Primary Completion
February 1, 2018
Study Completion
May 1, 2019
Last Updated
August 13, 2019
Results First Posted
August 13, 2019
Record last verified: 2019-07