An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Placement of an Arteriovenous Graft to Facilitate Hemodialysis Access
NCT ID: NCT01806584
Last Updated: 2021-06-08
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
32 participants
INTERVENTIONAL
2013-03-28
2014-10-23
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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SRM003
SRM003
One time implant (3 SRM003 pieces) on surgery day.
Participating Site's standard practice
Participating Site's standard practice
Subjects will receive sites' standard practice treatment during the surgical procedure
Interventions
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SRM003
One time implant (3 SRM003 pieces) on surgery day.
Participating Site's standard practice
Subjects will receive sites' standard practice treatment during the surgical procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Akdhc Medical Research Services
Phoenix, Arizona, United States
Tucson Vascular Consultants
Tucson, Arizona, United States
Ladenheim Dialysis Access Center
Fresno, California, United States
California Institute of Renal Research
La Mesa, California, United States
VA Long Beach Health Care System Pharmacy
Long Beach, California, United States
The Regents University of California Los Angeles
Los Angeles, California, United States
California Institute of Renal Research
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Tampa General Hospital
Tampa, Florida, United States
Georgia Regents University
Augusta, Georgia, United States
Illinois Kidney Disease & Hypertension Center
Peoria, Illinois, United States
University of Louisville
Louisville, Kentucky, United States
Ochsner Baptist Medical Center, Clinical Trials Unit
New Orleans, Louisiana, United States
Louisiana State University Health Science Center Shreveport
Shreveport, Louisiana, United States
Baystate Medical Center Pharmacy
Springfield, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Renaissance Renal Research Institute, LLC
Detroit, Michigan, United States
McLaren Northern Michigan Hospital-NISUS Research
Petoskey, Michigan, United States
Providence Hospital, Research Dept.
Southfield, Michigan, United States
Clinical Research Consultants, LLC
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Sierra Nevada Nephrology Consultants
Reno, Nevada, United States
United Health Services
Johnson City, New York, United States
Mount Sinai School of Medicine Lab
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, United States
ECU Department of Nephrology and Hypertension
Greenville, North Carolina, United States
Sanford Research/USD-Fargo
Fargo, North Dakota, United States
University of Cincinnati Physicians Company
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Toledo Hospital
Toledo, Ohio, United States
Kaiser Permanente Northwest
Milwaukie, Oregon, United States
Northwest Renal Clinic, Inc.
Portland, Oregon, United States
Penn Medicine, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Delaware Valley Nephrology and Hypertension Associates, PC
Philadelphia, Pennsylvania, United States
Temple University School of Medicine
Philadelphia, Pennsylvania, United States
SC Nephrology & Hypertension Center, Inc.
Orangeburg, South Carolina, United States
Erlanger Hospital Pharmacy
Chattanooga, Tennessee, United States
Nephrology Associates, P.C.
Nashville, Tennessee, United States
Baylor College of Medicine ICTR
Houston, Texas, United States
Fletcher Allen Health Care Renal Service
Burlington, Vermont, United States
Sentara Vascular Specialists
Norfolk, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Other Identifiers
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AVG01-SRM003
Identifier Type: -
Identifier Source: org_study_id
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