Study Stopped
Development of SRM003 was discontinued based on portfolio prioritization.
An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Placement of an Arteriovenous Graft to Facilitate Hemodialysis Access
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
1 other identifier
interventional
32
1 country
46
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2013
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2013
CompletedFirst Posted
Study publicly available on registry
March 7, 2013
CompletedStudy Start
First participant enrolled
March 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2014
CompletedResults Posted
Study results publicly available
December 31, 2015
CompletedJune 8, 2021
May 1, 2021
1.6 years
March 5, 2013
October 16, 2015
May 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Percentage of Participants With Loss of Assisted Primary Patency
Up to 78 weeks after surgery
Percentage of Participants With Loss of Secondary Patency
Up to 78 weeks after surgery
Number of Interventions to Establish, Maintain, or Restore Patency
26 weeks after surgery
Study Arms (2)
SRM003
ACTIVE COMPARATORParticipating Site's standard practice
OTHERInterventions
One time implant (3 SRM003 pieces) on surgery day.
Subjects will receive sites' standard practice treatment during the surgical procedure
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (46)
Akdhc Medical Research Services
Phoenix, Arizona, 85012, United States
Tucson Vascular Consultants
Tucson, Arizona, 85745, United States
Ladenheim Dialysis Access Center
Fresno, California, 93710, United States
California Institute of Renal Research
La Mesa, California, 91942, United States
VA Long Beach Health Care System Pharmacy
Long Beach, California, 90822, United States
The Regents University of California Los Angeles
Los Angeles, California, 90025, United States
California Institute of Renal Research
San Diego, California, 92123, United States
University of California, San Francisco
San Francisco, California, 94143, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
Yale University School of Medicine
New Haven, Connecticut, 06520-8042, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Georgia Regents University
Augusta, Georgia, 30912, United States
Illinois Kidney Disease & Hypertension Center
Peoria, Illinois, 61603, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Ochsner Baptist Medical Center, Clinical Trials Unit
New Orleans, Louisiana, 70115, United States
Louisiana State University Health Science Center Shreveport
Shreveport, Louisiana, 71130, United States
Baystate Medical Center Pharmacy
Springfield, Massachusetts, 01199, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Renaissance Renal Research Institute, LLC
Detroit, Michigan, 48236, United States
McLaren Northern Michigan Hospital-NISUS Research
Petoskey, Michigan, 49770, United States
Providence Hospital, Research Dept.
Southfield, Michigan, 48075, United States
Clinical Research Consultants, LLC
Kansas City, Missouri, 64111, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Sierra Nevada Nephrology Consultants
Reno, Nevada, 89511, United States
United Health Services
Johnson City, New York, 13790, United States
Mount Sinai School of Medicine Lab
New York, New York, 10029, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, 28204, United States
ECU Department of Nephrology and Hypertension
Greenville, North Carolina, 27834, United States
Sanford Research/USD-Fargo
Fargo, North Dakota, 58122, United States
University of Cincinnati Physicians Company
Cincinnati, Ohio, 45267, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Toledo Hospital
Toledo, Ohio, 43560, United States
Kaiser Permanente Northwest
Milwaukie, Oregon, 97267, United States
Northwest Renal Clinic, Inc.
Portland, Oregon, 97210, United States
Penn Medicine, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
Delaware Valley Nephrology and Hypertension Associates, PC
Philadelphia, Pennsylvania, 19118, United States
Temple University School of Medicine
Philadelphia, Pennsylvania, 19140, United States
SC Nephrology & Hypertension Center, Inc.
Orangeburg, South Carolina, 29118, United States
Erlanger Hospital Pharmacy
Chattanooga, Tennessee, 37403, United States
Nephrology Associates, P.C.
Nashville, Tennessee, 37205, United States
Baylor College of Medicine ICTR
Houston, Texas, 77030, United States
Fletcher Allen Health Care Renal Service
Burlington, Vermont, 05401, United States
Sentara Vascular Specialists
Norfolk, Virginia, 23507, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study was discontinued early due to Sponsor decision.
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2013
First Posted
March 7, 2013
Study Start
March 28, 2013
Primary Completion
October 23, 2014
Study Completion
October 23, 2014
Last Updated
June 8, 2021
Results First Posted
December 31, 2015
Record last verified: 2021-05