An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Placement of an Arteriovenous Graft to Facilitate Hemodialysis Access
This trial is active, not recruiting.
|Treatments||srm003, participating site's standard practice|
|Start date||March 2013|
|End date||October 2014|
|Trial size||200 participants|
|Trial identifier||NCT01806584, AVG01-SRM003|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Phoenix, AZ||Akdhc Medical Research Services||no longer recruiting|
|Tucson, AZ||Tucson Vascular Consultants||no longer recruiting|
|Fresno, CA||Ladenheim Dialysis Access Center||no longer recruiting|
|La Mesa, CA||California Institute of Renal Research||no longer recruiting|
|Long Beach, CA||VA Long Beach Health Care System Pharmacy||no longer recruiting|
|Los Angeles, CA||The Regents University of California Los Angeles||no longer recruiting|
|San Diego, CA||California Institute of Renal Research||no longer recruiting|
|San Francisco, CA||University of California, San Francisco||no longer recruiting|
|Aurora, CO||University of Colorado Denver||no longer recruiting|
|New Haven, CT||Yale University School of Medicine||no longer recruiting|
|Tampa, FL||Tampa General Hospital||no longer recruiting|
|Augusta, GA||Georgia Regents University||no longer recruiting|
|Peoria, IL||Illinois Kidney Disease & Hypertension Center||no longer recruiting|
|Louisville, KY||University of Louisville||no longer recruiting|
|New Orleans, LA||Ochsner Baptist Medical Center, Clinical Trials Unit||no longer recruiting|
|Shreveport, LA||Louisiana State University Health Science Center Shreveport||no longer recruiting|
|Springfield, MA||Baystate Medical Center Pharmacy||no longer recruiting|
|Detroit, MI||Renaissance Renal Research Institute, LLC||no longer recruiting|
|Detroit, MI||Henry Ford Hospital||no longer recruiting|
|Petoskey, MI||McLaren Northern Michigan Hospital-NISUS Research||no longer recruiting|
|Southfield, MI||Providence Hospital, Research Dept.||no longer recruiting|
|Kansas City, MO||Clinical Research Consultants, LLC||no longer recruiting|
|St. Louis, MO||Washington University School of Medicine||no longer recruiting|
|Reno, NV||Sierra Nevada Nephrology Consultants||no longer recruiting|
|Bronx, NY||Montefiore Medical Center||no longer recruiting|
|Johnson City, NY||United Health Services||no longer recruiting|
|New York, NY||Mount Sinai School of Medicine Lab||no longer recruiting|
|Charlotte, NC||Metrolina Nephrology Associates, PA||no longer recruiting|
|Greenville, NC||ECU Department of Nephrology and Hypertension||no longer recruiting|
|Fargo, NC||Sanford Research/USD-Fargo||no longer recruiting|
|Cincinnati, OH||University of Cincinnati Physicians Company||no longer recruiting|
|Cleveland, OH||The Cleveland Clinic Foundation||no longer recruiting|
|Columbus, OH||The Ohio State University||no longer recruiting|
|Toledo, OH||Toledo Hospital||no longer recruiting|
|Milwaukie, OR||Kaiser Permanente Northwest||no longer recruiting|
|Portland, OR||Northwest Renal Clinic, Inc.||no longer recruiting|
|Philadelphia, PA||Temple University School of Medicine||no longer recruiting|
|Philadelphia, PA||Delaware Valley Nephrology and Hypertension Associates, PC||no longer recruiting|
|Philadelphia, PA||Penn Medicine, Perelman Center for Advanced Medicine||no longer recruiting|
|Orangeburg, SC||SC Nephrology & Hypertension Center, Inc.||no longer recruiting|
|Chattanooga, TN||Erlanger Hospital Pharmacy||no longer recruiting|
|Nashville, TN||Nephrology Associates, P.C.||no longer recruiting|
|Houston, TX||Baylor College of Medicine ICTR||no longer recruiting|
|Burlington, VT||Fletcher Allen Health Care Renal Service||no longer recruiting|
|Norfolk, VA||Sentara Vascular Specialists||no longer recruiting|
|Madison, WI||University of Wisconsin||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Compare the duration of assisted primary and secondary patency for arteriovenous grafts treated with SRM003 with those treated with participating sites' standard practice.
time frame: Up to 78 weeks
Compare the incidence of AVG-related thrombosis and/or access site infection within the first 6 weeks after surgery for AVGs treated with SRM003 with that for AVGs randomized to participating sites' standard practice.
time frame: Up to 78 weeks
Male or female participants at least 18 years old.
- 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.
- Subject who is of child bearing potential must agree to use adequate contraception for 6 months after randomization.
- 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.
- Subject must have a life expectancy of at least 78 weeks after randomization.
- Subject must be able to understand and be willing to complete all study requirements.
- 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.
- Subject has had more than 3 access placement surgeries (defined as a new access, not a revision) in the target limb.
- Subject has medical conditions and diseases that may cause non-compliance with the protocol
- Subject has a known allergy to bovine/porcine products or collagen/gelatin products.
- Subject has a history of intravenous drug use within 6 months prior to screening
- Subject is morbidly obese, defined as having a body mass index >40.
- Pregnant or nursing woman, or plans to become pregnant during the study.
|Official title||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|
|Principal investigator||Steven Steinberg|
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