Clinical trial NCT02414841: A Study of Vonapanitase (PRT-201) Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-2)
Official title: Multicenter, Double Blind, Placebo Controlled Study of Vonapanitase (PRT- 201) Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Keywords: radiocephalic
arteriovenous fistula
AVF
hemodialysis
PRT-201
vonapanitase
vascular access
kidney
renal
PATENCY-2
secondary patency
fistula abandonment
use for hemodialysis
Lead sponsor: Proteon Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-04-13
Enrollment: 696
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age of at least 18 years.
2. Life expectancy of at least 6 months.
3. Diagnosis of CKD.
4. Planned creation of a new radiocephalic AVF (revision of an existing AVF is not eligible).
5. Ability to understand and comply with the requirements of the entire study and to communicate with the study team.
6. Written informed consent using a document that has been approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
7. 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.

Exclusion Criteria:

1. 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.
2. Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study.
3. Previous treatment with vonapanitase (PRT-201).
4. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within the previous 90 days prior to signing informed consent.

Primary outcomes:
measure: Kaplan-Meier Estimate of Secondary AVF Patency
timeFrame: Median time from AVF creation to AVF abandonment (secondary patency), assessed up to 1 year.
measure: Number of Participants With AVF Use for Hemodialysis
timeFrame: Assessed at up to 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: AKDHC Medical Research Services, LLC
state: Arizona
city: Tucson
country: United States
facility: Banner University Medical Center Tucson
state: Arizona
city: Tucson
country: United States
facility: AKDHC Medical Research Services, LLc
state: Arizona
city: Loma Linda
country: United States
facility: VA Loma Linda Healthcare System
state: California
city: Long Beach
country: United States
facility: VA Medical Center Long Beach
state: California
city: Los Angeles
country: United States
facility: Keck University Hospital at USC
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: San Diego
country: United States
facility: California Institute of Renal Research
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Peoria
country: United States
facility: RenalCare Associates, S.C.
state: Illinois
city: Fort Wayne
country: United States
facility: Lutheran Hospital Network of Indiana
state: Indiana
city: Iowa City
country: United States
facility: The University of Iowa Hospitals and Clinics
state: Iowa
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Greenwood
country: United States
facility: Greenwood Leflore Hospital
state: Mississippi
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
city: New York
country: United States
facility: New York Presbyterian Hospital-Weill Cornell Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburg Healthcare System
state: Pennsylvania
city: Orangeburg
country: United States
facility: SC Nephrology and Hypertension Center, Inc.
state: South Carolina
city: Knoxville
country: United States
facility: Knoxville Kidney Center
state: Tennessee
city: Austin
country: United States
facility: Cardiothoracis and Vascular Surgeons
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Bellevue
country: United States
facility: Lake Washington Vascular Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and PH
state: Wisconsin
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: London
country: Canada
facility: London Health Science Center
state: Ontario
city: Toronto
country: Canada
facility: University Health Network Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre- Royal Victoria Hospital
state: Quebec
Study officials:
References:
citation: Peden 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.