An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2013
End Date:October 2014

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A Phase 2, Single-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy and Safety of SRM003 (Vascugel®) in Improving the Rate of Arteriovenous Fistula Maturation and Use in Subjects Undergoing Surgery for Creation of an Arteriovenous Fistula for Hemodialysis Access

A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard
practice treatment in improving the rate of AVF maturation and use in subjects with
end-stage renal disease undergoing surgery for creation of an AVF to facilitate hemodialysis
access.

It is hypothesized that when placed outside the blood vessel, the seeded SRM003 gelatin
matrix containing endothelial cells can provide a continuous supply of multiple growth
regulatory compounds to the underlying cells within the blood vessel, while being protected
from the effects of blood flow in the vessel(s) or complications resulting from being in
direct contact with the point of injury.


Inclusion Criteria:

1. Subject must be 18 years of age or older at the time of signing and dating informed
consent (no upper age limit), can be male or female.

2. Subject who is of child bearing potential must agree to use adequate contraception
for 6 months after randomization.

3. Subject must be currently undergoing hemodialysis or anticipating the start of
hemodialysis and must require a new permanent, suitable access for the AVF creation
in the upper extremity.

4. Subject must have a life expectancy of at least 26 weeks after randomization.

5. Subject must be able to understand and be willing to complete all study requirements.

Exclusion Criteria:

1. Subject is currently on an active organ transplant list from a deceased donor or is
undergoing assessment and expects to be placed on the active organ or bone marrow
transplant list within the next 26 weeks from surgery, or expects to receive a living
donor organ or bone marrow within the next 26 weeks and is unwilling to change
transplant list status to "hold" for 3 months after randomization.

2. Subject has had more than 1 access placement surgery (defined as a new access, not a
revision) in the target limb.

3. Subject has medical conditions and diseases that may cause non-compliance with the
protocol

4. Subject has a known allergy to bovine/porcine products or collagen/gelatin products.

5. Subject has a history of intravenous drug use within 6 months prior to screening

6. Subject is morbidly obese, defined as having a body mass index >40.

7. Pregnant or nursing woman, or plans to become pregnant during the study.
We found this trial at
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Long Beach, California 90822
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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1 Tampa General Cir
Tampa, Florida 33606
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Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Tampa, FL
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820 North Chelan Avenue
Wenatchee, Washington 98801
509) 663-8711
Wenatchee Valley Medical Center Established on July 21, 2013, Confluence Health is an affiliation between...
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1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Burlington, Vermont 05401
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Charlotte, North Carolina 28204
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Chattanooga, Tennessee 37403
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Cincinnati, OH
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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281 W. Lane Ave
Columbus, Ohio 43210
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Detroit, MI
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Fargo, North Dakota 58122
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Fresno, California 93710
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Greenville, North Carolina 27834
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Houston, Texas 77030
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Johnson City, New York 13790
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Kansas City, Missouri 64111
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La Mesa, California 91942
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Los Angeles, California 90025
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
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Madison, Wisconsin 53792
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Milwaukie, Oregon 97267
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Nashville, Tennessee 37205
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333 Cedar St
New Haven, Connecticut 06504
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New York, New York 10029
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Norfolk, Virginia 23507
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Orangeberg, South Carolina 29118
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Philadelphia, Pennsylvania 19140
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Southfield, Michigan 48075
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Springfield, Massachusetts 01199
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St. Louis, Missouri 63108
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2142 N Cove Blvd
Toledo, Ohio 43606
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Tucson, Arizona 85745
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