Clinical trial NCT02110901: A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1)
Official title: Multicenter, Double-Blind, Placebo-Controlled Study of 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
vascular access
kidney
renal
vonapanitase
PATENCY-1
Lead sponsor: Proteon Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-04-10
Enrollment: 349
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 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.


Eligibility criteria: Inclusion Criteria:

1. Age of at least 18 years.
2. Life expectancy of at least 6 months.
3. Diagnosis of Chronic Kidney Disease (CKD).
4. Planned creation of a new radiocephalic arteriovenous fistula (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).
7. 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.

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 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: Time to AVF Primary Unassisted Patency
timeFrame: Days from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency, assessed up to 1 year
measure: Kaplan-Meier Estimate of Secondary AVF Patency
timeFrame: Median time from AVF creation until AVF abandonment (secondary patency), assessed up to 1 year
Secondary outcomes:
Other outcomes:
measure: Number of Participants With Unassisted AVF Maturation by Ultrasound
timeFrame: Assessed 3 months after AVF creation
measure: Number of Participants With Unassisted AVF Use for Hemodialysis
timeFrame: Assessed at 12 months
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: AKDHC Medical Research Services, LLc
state: Arizona
city: Laguna Hills
country: United States
facility: Alliance Research Center
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 Medical Center
state: California
city: San Diego
country: United States
facility: California Institute of Renal Research
state: California
city: San Francisco
country: United States
facility: UCSF Division of Vascular & Endovascular Surgery
state: California
city: Chicago
country: United States
facility: Rush Medical Center
state: Illinois
city: Peoria
country: United States
facility: Renal Care Associates
state: Illinois
city: Fort Wayne
country: United States
facility: Lutheran Hospital Network of Indiana
state: Indiana
city: Iowa City
country: United States
facility: 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: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Easton
country: United States
facility: University of Maryland Shore Medical Center at Easton
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
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: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Salisbury
country: United States
facility: W.G. Hefner VA Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Tulsa
country: United States
facility: The University of Oklahoma College of Medicine
state: Oklahoma
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: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Bellevue
country: United States
facility: Lake Washington Vascular Center
state: Washington
Study officials:
References:
citation: Bleyer 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.