An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Placement of an Arteriovenous Graft to Facilitate Hemodialysis Access
- Conditions
- Arteriovenous Graft
- Interventions
- Other: Participating Site's standard practiceBiological: SRM003
- Registration Number
- NCT01806584
- Lead Sponsor
- Shire
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 32
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Participating Site's standard practice Participating Site's standard practice - SRM003 SRM003 -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Loss of Unassisted Primary Patency Up to 78 weeks after surgery Unassisted primary patency (intervention--free access survival) was defined as the duration of time in days from the date of randomization (arteriovenous graft \[AVG\] placement) until the first date of (a) any intervention designed to establish, maintain, or restore patency, (b) occlusion (commonly due to thrombosis), or (c) access abandonment. Assessment of AVG patency was evaluated during physical examination of the subject's AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site's standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access.
- Secondary Outcome Measures
Name Time Method Number of Interventions to Establish, Maintain, or Restore Patency 26 weeks after surgery The total numbers of interventions to establish, maintain, or restore patency was assessed at the Week 26 visit.
Percentage of Participants With Loss of Secondary Patency Up to 78 weeks after surgery Secondary patency (access survival until abandonment) was defined as the duration of time in days from the date of randomization (AVG placement) until the date of access abandonment. Assessment of AVG patency was evaluated during physical examination of the subject's AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site's standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access.
Percentage of Participants With Loss of Assisted Primary Patency Up to 78 weeks after surgery Assisted primary patency (thrombosis--free access survival) was defined as the duration of time in days from the date of randomization (AVG placement) until the first date of (a) occlusion (commonly due to thrombosis) or (b) access abandonment. Assessment of AVG patency was evaluated during physical examination of the subject's AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site's standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access.
Trial Locations
- Locations (45)
Providence Hospital, Research Dept.
🇺🇸Southfield, Michigan, United States
Penn Medicine, Perelman Center for Advanced Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Delaware Valley Nephrology and Hypertension Associates, PC
🇺🇸Philadelphia, Pennsylvania, United States
Fletcher Allen Health Care Renal Service
🇺🇸Burlington, Vermont, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
The Regents University of California Los Angeles
🇺🇸Los Angeles, California, United States
Sierra Nevada Nephrology Consultants
🇺🇸Reno, Nevada, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Georgia Regents University
🇺🇸Augusta, Georgia, United States
Baystate Medical Center Pharmacy
🇺🇸Springfield, Massachusetts, United States
McLaren Northern Michigan Hospital-NISUS Research
🇺🇸Petoskey, Michigan, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
VA Long Beach Health Care System Pharmacy
🇺🇸Long Beach, California, United States
Louisiana State University Health Science Center Shreveport
🇺🇸Shreveport, Louisiana, United States
Ochsner Baptist Medical Center, Clinical Trials Unit
🇺🇸New Orleans, Louisiana, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
Sanford Research/USD-Fargo
🇺🇸Fargo, North Dakota, United States
Clinical Research Consultants, LLC
🇺🇸Kansas City, Missouri, United States
Sentara Vascular Specialists
🇺🇸Norfolk, Virginia, United States
Erlanger Hospital Pharmacy
🇺🇸Chattanooga, Tennessee, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Illinois Kidney Disease & Hypertension Center
🇺🇸Peoria, Illinois, United States
United Health Services
🇺🇸Johnson City, New York, United States
Baylor College of Medicine ICTR
🇺🇸Houston, Texas, United States
Tucson Vascular Consultants
🇺🇸Tucson, Arizona, United States
Ladenheim Dialysis Access Center
🇺🇸Fresno, California, United States
ECU Department of Nephrology and Hypertension
🇺🇸Greenville, North Carolina, United States
Mount Sinai School of Medicine Lab
🇺🇸New York, New York, United States
Metrolina Nephrology Associates, PA
🇺🇸Charlotte, North Carolina, United States
Northwest Renal Clinic, Inc.
🇺🇸Portland, Oregon, United States
Kaiser Permanente Northwest
🇺🇸Milwaukie, Oregon, United States
Temple University School of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
SC Nephrology & Hypertension Center, Inc.
🇺🇸Orangeburg, South Carolina, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Akdhc Medical Research Services
🇺🇸Phoenix, Arizona, United States
California Institute of Renal Research
🇺🇸San Diego, California, United States
Renaissance Renal Research Institute, LLC
🇺🇸Detroit, Michigan, United States
University of Cincinnati Physicians Company
🇺🇸Cincinnati, Ohio, United States
Nephrology Associates, P.C.
🇺🇸Nashville, Tennessee, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States