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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01806584
Other study ID # AVG01-SRM003
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date March 28, 2013
Est. completion date October 23, 2014

Study information

Verified date May 2021
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 32
Est. completion date October 23, 2014
Est. primary completion date October 23, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
SRM003
One time implant (3 SRM003 pieces) on surgery day.
Other:
Participating Site's standard practice
Subjects will receive sites' standard practice treatment during the surgical procedure

Locations

Country Name City State
United States Georgia Regents University Augusta Georgia
United States University of Colorado Denver Aurora Colorado
United States Montefiore Medical Center Bronx New York
United States Fletcher Allen Health Care Renal Service Burlington Vermont
United States Metrolina Nephrology Associates, PA Charlotte North Carolina
United States Erlanger Hospital Pharmacy Chattanooga Tennessee
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 Henry Ford Hospital Detroit Michigan
United States Renaissance Renal Research Institute, LLC Detroit Michigan
United States Sanford Research/USD-Fargo Fargo North Dakota
United States Ladenheim Dialysis Access Center Fresno California
United States ECU Department of Nephrology and Hypertension Greenville North Carolina
United States Baylor College of Medicine ICTR Houston Texas
United States United Health Services Johnson City New York
United States Clinical Research Consultants, LLC Kansas City Missouri
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 University of Louisville Louisville Kentucky
United States University of Wisconsin Madison Wisconsin
United States Kaiser Permanente Northwest Milwaukie Oregon
United States Nephrology Associates, P.C. Nashville Tennessee
United States Yale University School of Medicine New Haven Connecticut
United States Ochsner Baptist Medical Center, Clinical Trials Unit New Orleans Louisiana
United States Mount Sinai School of Medicine Lab New York New York
United States Sentara Vascular Specialists Norfolk Virginia
United States SC Nephrology & Hypertension Center, Inc. Orangeburg South Carolina
United States Illinois Kidney Disease & Hypertension Center Peoria Illinois
United States McLaren Northern Michigan Hospital-NISUS Research Petoskey Michigan
United States Delaware Valley Nephrology and Hypertension Associates, PC Philadelphia Pennsylvania
United States Penn Medicine, Perelman Center for Advanced Medicine Philadelphia Pennsylvania
United States Temple University School of Medicine Philadelphia Pennsylvania
United States Akdhc Medical Research Services Phoenix Arizona
United States Northwest Renal Clinic, Inc. Portland Oregon
United States Sierra Nevada Nephrology Consultants Reno Nevada
United States Washington University School of Medicine Saint Louis Missouri
United States California Institute of Renal Research San Diego California
United States University of California, San Francisco San Francisco California
United States Louisiana State University Health Science Center Shreveport Shreveport Louisiana
United States Providence Hospital, Research Dept. Southfield Michigan
United States Baystate Medical Center Pharmacy Springfield Massachusetts
United States Tampa General Hospital Tampa Florida
United States Toledo Hospital Toledo Ohio
United States Tucson Vascular Consultants Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Loss of Unassisted Primary Patency 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. Up to 78 weeks after surgery
Secondary Percentage of Participants With Loss of Assisted Primary Patency 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. Up to 78 weeks after surgery
Secondary Percentage of Participants With Loss of Secondary Patency 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. Up to 78 weeks after surgery
Secondary Number of Interventions to Establish, Maintain, or Restore Patency The total numbers of interventions to establish, maintain, or restore patency was assessed at the Week 26 visit. 26 weeks after surgery
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