A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease
NCT ID: NCT01001351
Last Updated: 2015-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
89 participants
INTERVENTIONAL
2009-09-30
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
Applied topically during surgery
PRT-201
PRT-201
Applied topically during surgery.
Interventions
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PRT-201
Applied topically during surgery.
Placebo
Applied topically during surgery
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Proteon Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Marco Wong, MD, PhD
Role: STUDY_DIRECTOR
Proteon Therapeutics, Inc
Locations
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Ladenheim Dialysis Access Center
Fresno, California, United States
California Institute of Renal Research
San Diego, California, United States
Washington Hospital/Medstar Research
Washington D.C., District of Columbia, United States
Indiana/Ohio Heart
Fort Wayne, Indiana, United States
Indiana University/Purdue University
Indianapolis, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Vascular Specialty Center
Baton Rouge, Louisiana, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts, United States
Weill Cornell Medical College
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Greenville Memorial Hospital
Greenville, South Carolina, United States
The Methodist Hospital
Houston, Texas, United States
Peripheral Vascular Associates
San Antonio, Texas, United States
Sentara Vascular Specialists
Norfolk, Virginia, United States
Countries
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References
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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.
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.
Other Identifiers
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PRT-201-102
Identifier Type: -
Identifier Source: org_study_id
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