Clinical trial NCT01001351: A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Graft Creation in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Arteriovenous Grafts (AVG)
Hemodialysis
Vascular Access
Dialysis
Graft
Access
vonapanitase
kidney
renal
Lead sponsor: Proteon Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-10-26
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: PRT-201 is a recombinant human type-I pancreatic elastase intended for local, long-lasting dilation of the AVG venous anastomosis and outflow vein. The goal of the treatment is to improve primary patency and long-term survival of AVGs and thereby provide patients with chronic kidney disease (CKD) a reliable and durable vascular access site for hemodialysis. Recent data indicate that up to three quarters of patients have loss of graft patency at one year, indicating a substantial need for new therapies. This clinical trial will explore the safety and dilatory effect of topically administered PRT-201 on the outflow vein of a newly placed upper extremity AVG.


Eligibility criteria: Inclusion Criteria:

1. Age of at least 18 years.
2. Chronic kidney disease with anticipated start of hemodialysis within 3 months or current hemodialysis dependence.
3. Planned creation of a new upper extremity AVG or "jump" graft

Exclusion Criteria:

1. Patients for whom this is the only potential site for an upper extremity vascular access.
2. Creation of a new AVG or "jump" graft in an upper extremity previously treated with an investigational gene or cell based therapy, or locally with an investigational pharmacological agent.
3. On physical examination or by other means, suspected proximal vein stenosis, occlusion, lack of continuity with the subclavian vein, central venous stenosis or central venous occlusion.
4. History or presence of an arterial aneurysm.
5. Previous treatment with PRT-201.

Primary outcomes:
measure: To assess the safety of a single topical dose of PRT-201.
timeFrame: Day of AVG creation and 4 weeks After surgery.
Secondary outcomes:
measure: Primary graft patency
timeFrame: 3, 6, 9 and 12 months after AVG creation.
measure: Secondary graft patency.
timeFrame: 3, 6, 9 and 12 months after AVG creation.
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Ladenheim Dialysis Access Center
state: California
city: San Diego
country: United States
facility: California Institute of Renal Research
state: California
city: Washington
country: United States
facility: Washington Hospital/Medstar Research
state: District of Columbia
city: Fort Wayne
country: United States
facility: Indiana/Ohio Heart
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University/Purdue University
state: Indiana
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: Brigham & Women's Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
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
state: Ohio
city: Greenville
country: United States
facility: Greenville Memorial Hospital
state: South Carolina
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: Peripheral Vascular Associates
state: Texas
city: Norfolk
country: United States
facility: Sentara Vascular Specialists
state: Virginia
Study officials:
affiliation: Proteon Therapeutics, Inc
name: Marco Wong, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Dwivedi AJ, Roy-Chaudhury P, Peden EK, Browne BJ, Ladenheim ED, Scavo VA, Gustafson PN, Wong MD, Magill M, Lindow F, Blair AT, Jaff MR, Franano FN, Burke SK. Application of human type I pancreatic elastase (PRT-201) to the venous anastomosis of arteriovenous grafts in patients with chronic kidney disease. J Vasc Access. 2014 Sep-Oct;15(5):376-84. doi: 10.5301/jva.5000235. Epub 2014 May 3.
citation: Mohamed I, Kamarizan MFA, Da Silva A. Medical adjuvant treatment to increase patency of arteriovenous fistulae and grafts. Cochrane Database Syst Rev. 2021 Jul 23;7(7):CD002786. doi: 10.1002/14651858.CD002786.pub4.