A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease
PRT-201-102
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
1 other identifier
interventional
89
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2009
Typical duration for phase_1
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 22, 2009
CompletedFirst Posted
Study publicly available on registry
October 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedApril 30, 2015
April 1, 2015
3.2 years
October 22, 2009
April 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety of a single topical dose of PRT-201.
Day of AVG creation and 4 weeks After surgery.
Secondary Outcomes (2)
Primary graft patency
3, 6, 9 and 12 months after AVG creation.
Secondary graft patency.
3, 6, 9 and 12 months after AVG creation.
Study Arms (2)
Placebo
PLACEBO COMPARATORPRT-201
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Age of at least 18 years.
- Chronic kidney disease with anticipated start of hemodialysis within 3 months or current hemodialysis dependence.
- Planned creation of a new upper extremity AVG or "jump" graft
You may not qualify if:
- Patients for whom this is the only potential site for an upper extremity vascular access.
- 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.
- 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.
- History or presence of an arterial aneurysm.
- Previous treatment with PRT-201.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Ladenheim Dialysis Access Center
Fresno, California, 93710, United States
California Institute of Renal Research
San Diego, California, 92123, United States
Washington Hospital/Medstar Research
Washington D.C., District of Columbia, 20010, United States
Indiana/Ohio Heart
Fort Wayne, Indiana, 46804, United States
Indiana University/Purdue University
Indianapolis, Indiana, 46202, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Vascular Specialty Center
Baton Rouge, Louisiana, 70809, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
University of Massachusetts
Worcester, Massachusetts, 01655, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Greenville Memorial Hospital
Greenville, South Carolina, 29615, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Peripheral Vascular Associates
San Antonio, Texas, 78205, United States
Sentara Vascular Specialists
Norfolk, Virginia, 23507, United States
Related Publications (2)
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.
PMID: 24811601RESULTMohamed 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.
PMID: 34298589DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marco Wong, MD, PhD
Proteon Therapeutics, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2009
First Posted
October 26, 2009
Study Start
September 1, 2009
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
April 30, 2015
Record last verified: 2015-04