Arteriovenous GraftPhase 2NCT01806584
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 study testing SRM003 and Participating Site's standard practice in people with Arteriovenous Graft, run by Shire at 46 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Graft
- What is being tested?
- SRM003 and Participating Site's standard practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 46 sitesUnited States
- Study dates
- 28 Mar 2013to 23 Oct 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
Georgia Regents University
Augusta, Georgia, 30912
University of Colorado Denver
Aurora, Colorado, 80045
Fletcher Allen Health Care Renal Service
Burlington, Vermont, 05401
Metrolina Nephrology Associates, PA
Charlotte, North Carolina, 28204
Erlanger Hospital Pharmacy
Chattanooga, Tennessee, 37403
University of Cincinnati Physicians Company
Cincinnati, Ohio, 45267
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43210
Henry Ford Hospital
Detroit, Michigan, 48202
Renaissance Renal Research Institute, LLC
Detroit, Michigan, 48236
Sanford Research/USD-Fargo
Fargo, North Dakota, 58122
Ladenheim Dialysis Access Center
Fresno, California, 93710
ECU Department of Nephrology and Hypertension
Greenville, North Carolina, 27834
Baylor College of Medicine ICTR
Houston, Texas, 77030
United Health Services
Johnson City, New York, 13790
Clinical Research Consultants, LLC
Kansas City, Missouri, 64111
California Institute of Renal Research
La Mesa, California, 91942
VA Long Beach Health Care System Pharmacy
Long Beach, California, 90822
The Regents University of California Los Angeles
Los Angeles, California, 90025
University of Louisville
Louisville, Kentucky, 40202
University of Wisconsin
Madison, Wisconsin, 53792
Kaiser Permanente Northwest
Milwaukie, Oregon, 97267
Nephrology Associates, P.C.
Nashville, Tennessee, 37205
Yale University School of Medicine
New Haven, Connecticut, 06520-8042
Ochsner Baptist Medical Center, Clinical Trials Unit
New Orleans, Louisiana, 70115
Mount Sinai School of Medicine Lab
New York, New York, 10029
Sentara Vascular Specialists
Norfolk, Virginia, 23507
SC Nephrology & Hypertension Center, Inc.
Orangeburg, South Carolina, 29118
Illinois Kidney Disease & Hypertension Center
Peoria, Illinois, 61603
McLaren Northern Michigan Hospital-NISUS Research
Petoskey, Michigan, 49770
Penn Medicine, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Delaware Valley Nephrology and Hypertension Associates, PC
Philadelphia, Pennsylvania, 19118
Temple University School of Medicine
Philadelphia, Pennsylvania, 19140
Akdhc Medical Research Services
Phoenix, Arizona, 85012
Northwest Renal Clinic, Inc.
Portland, Oregon, 97210
Sierra Nevada Nephrology Consultants
Reno, Nevada, 89511
California Institute of Renal Research
San Diego, California, 92123
University of California, San Francisco
San Francisco, California, 94143
Louisiana State University Health Science Center Shreveport
Shreveport, Louisiana, 71130
Providence Hospital, Research Dept.
Southfield, Michigan, 48075
Baystate Medical Center Pharmacy
Springfield, Massachusetts, 01199
Washington University School of Medicine
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
Toledo Hospital
Toledo, Ohio, 43560
Tucson Vascular Consultants
Tucson, Arizona, 85745
About this 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
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.
- Conditions
- Arteriovenous Graft
- Being tested
- SRM003, Participating Site's standard practice
- Keywords
- Vascular Injury, Arteriovenous Graft Surgery, Hemodialysis Access
- Medical subject headings
- Vascular System Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRM003Biological
Also called Allogeneic human aortic endothelial cells cultured in a gelatin matrix (Gelfoam®).
One time implant (3 SRM003 pieces) on surgery day.
Participating Site's standard practiceOther
Subjects will receive sites' standard practice treatment during the surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| SRM003 | Active comparator | Not described Receives: Biological: SRM003 |
| Participating Site's standard practice | Other | Not described Receives: Other: Participating Site's standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 78 weeks after surgery
Secondary outcomes (3)
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.
Measured: Up to 78 weeks after surgery
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.
Measured: Up to 78 weeks after surgery
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.
Measured: 26 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study start28 Mar 2013
- Primary completion23 Oct 2014
- Study completion23 Oct 2014
Why it stopped: Development of SRM003 was discontinued based on portfolio prioritization.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arteriovenous GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806584
- Sponsor's protocol ID
- AVG01-SRM003
- Status last verified
- May 2021
- First submitted
- 5 Mar 2013
- Last updated
- 8 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01806584
- Acronym / sponsor ID
- AVG01-SRM003
- Conditions
- Arteriovenous Graft
- Keywords
- Vascular Injury, Arteriovenous Graft Surgery, Hemodialysis Access
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Development of SRM003 was discontinued based on portfolio prioritization.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2013 (actual)
- Primary completion
- 23 Oct 2014 (actual)
- Study completion
- 23 Oct 2014 (actual)
- First posted
- 7 Mar 2013 (estimated)
- Results
- Posted 31 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SRM003 | Active comparator | Biological: SRM003 |
| Participating Site's standard practice | Other | Other: Participating Site's standard practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRM003Also: Allogeneic human aortic endothelial cells cultured in a gelatin matrix (Gelfoam®).One time implant (3 SRM003 pieces) on surgery day. | Biological | SRM003 |
| Participating Site's standard practiceSubjects will receive sites' standard practice treatment during the surgical procedure | Other | Participating Site's standard practice |
Primary outcome
Percentage of Participants With Loss of Unassisted Primary Patency
Time frame: 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.
3 secondary outcomes
Percentage of Participants With Loss of Assisted Primary Patency
Time frame: Up to 78 weeks after surgery
Percentage of Participants With Loss of Secondary Patency
Time frame: Up to 78 weeks after surgery
Number of Interventions to Establish, Maintain, or Restore Patency
Time frame: 26 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SRM003 and Participating Site's standard practice in people with Arteriovenous Graft, run by Shire at 46 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Loss of Unassisted Primary Patency (time frame: Up to 78 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.