Clinical trial NCT01305824: A Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Official title: Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Keywords: arteriovenous fistula
AVF
hemodialysis
vascular access
dialysis
fistula
PRT-201
vonapanitase
kidney
renal
Lead sponsor: Proteon Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-03-01
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age of at least 18 years.
2. Life expectancy of at least 6 months.
3. Chronic kidney disease on hemodialysis, or with anticipated start of hemodialysis within 6 months.
4. Planned creation of a new radiocephalic or brachiocephalic AVF. Revisions of an existing AVF and transposed AVF are not acceptable.

Exclusion Criteria:

1. History or presence of an arterial aneurysm.
2. 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.
3. 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.
4. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.

Primary outcomes:
measure: Primary AVF patency.
timeFrame: 12 months after AVF creation
measure: Number of participants with adverse events as a measure of safety and tolerability of PRT-201.
timeFrame: 12 months after AVF creation.
Secondary outcomes:
measure: Secondary Fistula Patency
timeFrame: 12 months after AVF creation
Other outcomes:
Locations:
city: San Diego
country: United States
facility: California Institute of Renal Research
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: San Francisco
country: United States
facility: UCSF
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: Indiana Ohio Heart
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baton Rouge
country: United States
facility: Vascular Specialty Center
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deconness Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Worcester
country: United States
facility: UMASS Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: St Clair Specialty Physicians
state: Michigan
city: Lansing
country: United States
facility: Thoracic & Cardiovascular Healthcare Foundation
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Legacy Oregon Surgical
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Norfolk
country: United States
facility: Sentara Medical Group
state: Virginia
Study officials:
References:
citation: 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.