Clinical trial NCT00679991: A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients
Official title: A Phase 1-2, Multi-Center, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Kidney Disease
Keywords: arteriovenous fistula
AVF
hemodialysis
vascular access
PRT 201
dose escalation
dialysis
fistula
access
vonapanitase
kidney
renal
Lead sponsor: Proteon Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-05-19
Enrollment: 66
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: PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel. The purpose of this study is to determine if PRT-201, when applied to a limited segment of blood vessel immediately after surgery to create an arteriovenous fistula (AVF), is safe, dilates the blood vessel, and increases blood flow through the AVF.


Eligibility criteria: Inclusion Criteria:

* Age of at least 18 years.
* Chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence.
* Planned creation of a new AVF.

Exclusion Criteria:

* Patients for whom this is the only potential site for an AVF.
* By physical examination, absence of radial or ulnar artery flow or non-patent palmer arch.
* Treatment with any investigational agent within the previous 30 days or investigational antibody therapy within 90 days of signing informed consent.
* Pregnancy, lactation or plans to become pregnant during the course of the study.

Primary outcomes:
measure: To assess the safety of a single topical dose of PRT-201. To assess the effect on the diameter of and blood flow through the AVF outflow vein.
timeFrame: 2 & 6 weeks after AVF creation
Secondary outcomes:
measure: The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis.
timeFrame: 3, 6, 9, and 12 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Clarian Health Partners/Indiana University/Purdue University
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
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: Springfield
country: United States
facility: Western New England Renal & Transplant Associates
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
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: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
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: Peden EK, Leeser DB, Dixon BS, El-Khatib MT, Roy-Chaudhury P, Lawson JH, Menard MT, Dember LM, Glickman MH, Gustafson PN, Blair AT, Magill M, Franano FN, Burke SK. A multi-center, dose-escalation study of human type I pancreatic elastase (PRT-201) administered after arteriovenous fistula creation. J Vasc Access. 2013 Apr-Jun;14(2):143-51. doi: 10.5301/jva.5000125. Epub 2012 Nov 20.