A Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
NCT ID: NCT01305824
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
PHASE2
151 participants
INTERVENTIONAL
2011-03-31
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
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PRT 201 (10 micrograms)
PRT-201
PRT-201 10 micrograms administered at the time of AVF creation.
Placebo
Placebo
Placebo administered at the time of AVF creation.
PRT-201 (30 micrograms)
PRT-201
PRT-201 30 micrograms administered at the time of AVF creation.
Interventions
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PRT-201
PRT-201 10 micrograms administered at the time of AVF creation.
Placebo
Placebo administered at the time of AVF creation.
PRT-201
PRT-201 30 micrograms administered at the time of AVF creation.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Proteon Therapeutics
INDUSTRY
Responsible Party
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Locations
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California Institute of Renal Research
San Diego, California, United States
Kaiser Permanente
San Diego, California, United States
UCSF
San Francisco, California, United States
Rush Medical Center
Chicago, Illinois, United States
Renal Care Associates
Peoria, Illinois, United States
Indiana Ohio Heart
Fort Wayne, Indiana, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Louisville
Louisville, Kentucky, United States
Vascular Specialty Center
Baton Rouge, Louisiana, United States
Beth Israel Deconness Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
UMASS Medical Center
Worcester, Massachusetts, United States
St Clair Specialty Physicians
Detroit, Michigan, United States
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, United States
Weill Cornell Medical College
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Legacy Oregon Surgical
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The Methodist Hospital
Houston, Texas, United States
Sentara Medical Group
Norfolk, Virginia, United States
Countries
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References
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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.
Other Identifiers
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PRT-201-201
Identifier Type: -
Identifier Source: org_study_id
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