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



Status:Terminated
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 the Treatment of Subjects With Vascular Injury Resulting From Arteriovenous Graft Surgery for Hemodialysis Access

A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard
practice treatment in extending the duration of primary patency after arteriovenous graft
surgery in subjects with end-stage renal disease.

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 prosthetic expanded
polytetrafluoroethylene AVG placed in the upper extremity.

4. Subject must have a life expectancy of at least 78 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 78 weeks from surgery, or expects to receive a living
donor organ or bone marrow within the next 78 weeks and is unwilling to change
transplant list status to "hold" for 3 months after randomization.

2. Subject has had more than 3 access placement surgeries (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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Charlotte, North Carolina 28204
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3550 Jerome Avenue
Bronx, New York 10467
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1 Tampa General Cir
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1120 15th Street
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13001 E. 17th Pl
Aurora, Colorado 80045
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Burlington, Vermont 05401
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Chattanooga, Tennessee 37403
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2049 E 100th St
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281 W. Lane Ave
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2799 W Grand Blvd
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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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La Mesa, California 91942
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Los Angeles, California 90025
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500 S Preston St
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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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2142 N Cove Blvd
Toledo, Ohio 43606
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Tucson, Arizona 85745
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