A Study of Vonapanitase (PRT-201) Administered Immediately After Radiocephalic Arteriovenous Fistula(AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-2)



Status:Active, not recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Hospital
Therapuetic Areas:Nephrology / Urology, Other
Healthy:No
Age Range:18 - 100
Updated:3/27/2019
Start Date:August 2015

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Multicenter, Double Blind, Placebo Controlled Study of Vonapanitase (PRT- 201) Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

This research study is designed to assess the safety and effectiveness of an experimental
drug called vonapanitase (PRT-201) in patients both receiving or expecting to receive
hemodialysis who have chronic kidney disease and who are undergoing surgery to create a new
access point to their bloodstream for hemodialysis. Vonapanitase is a protein that has been
shown in previous research studies to help keep vessels patent when applied to the outside
surface of the blood vessels (arteries and veins) in patients who undergo surgery to create
an arteriovenous fistula (AVF). The purpose of this study is to determine whether
vonapanitase when applied to a limited segment of your blood vessel (about 2 inches)
immediately after surgery is safe and improves the patency of your AVF.


Inclusion Criteria:

1. Age of at least 18 years.

2. Life expectancy of at least 6 months.

3. Diagnosis of CKD.

4. Planned creation of a new radiocephalic AVF (revision of an existing AVF is not
eligible).

5. Ability to understand and comply with the requirements of the entire study and to
communicate with the study team.

6. Written informed consent using a document that has been approved by the Institutional
Review Board (IRB) or Independent Ethics Committee (IEC).

7. If female and of childbearing potential (premenopausal and not surgically sterile)
must have a negative serum pregnancy test at the screening visit and be willing to use
contraception from the time of the screening visit to 2 weeks following study drug
administration. Acceptable methods of birth control include abstinence, barrier
methods, hormones, or intra-uterine device.

Exclusion Criteria:

1. 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 or
squamous cell skin cancer, or any cancer in situ.

2. Presence of any significant medical condition that might significantly confound the
collection of safety and efficacy data in this study.

3. Previous treatment with vonapanitase (PRT-201).

4. Treatment with any investigational drug within the previous 30 days or investigational
antibody therapy within the previous 90 days prior to signing informed consent.
We found this trial at
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San Francisco, California 94115
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
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Allentown, Pennsylvania 18105
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Ann Arbor, Michigan 48113
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Bellevue, Washington 98004
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
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Edmonton, Alberta T6G 2J2
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Fort Wayne, Indiana 46804
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Greenwood, Mississippi 38930
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Houston, Texas 77030
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
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Kansas City, Missouri 64111
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Knoxville, Tennessee 37923
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Loma Linda, California 92357
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Long Beach, California 90822
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Los Angeles, California 90033
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
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New Orleans, Louisiana 70112
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Orangeburg, South Carolina
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Peoria, Illinois 61603
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Phoenix, Arizona 85012
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Pittsburgh, Pennsylvania 15240
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San Diego, California 92120
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San Diego, California 92123
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Tucson, Arizona 85719
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Winston-Salem, North Carolina 27157
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Worcester, Massachusetts 01655
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