Arteriovenous FistulaPhase 2NCT01806545
An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access
A Phase 2 study testing SRM003 and Participating Site's standard practice in people with Arteriovenous Fistula, run by Shire at 47 sites in United States.
Trial summary
A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in improving the rate of AVF maturation and use in subjects with end-stage renal disease undergoing surgery for creation of an AVF to facilitate hemodialysis access. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula
- 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
- 64 participants
- Where
- 47 sitesUnited States
- Study dates
- 26 Mar 2013to 27 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, suitable access for the AVF creation in the upper extremity.
- Subject must have a life expectancy of at least 26 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 26 weeks from surgery, or expects to receive a living donor organ or bone marrow within the next 26 weeks and is unwilling to change transplant list status to "hold" for 3 months after randomization.
- Subject has had more than 1 access placement surgery (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
47 sites in 1 country.
47 sites in 1 country
United States47 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
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801
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 Improving the Rate of Arteriovenous Fistula Maturation and Use in Subjects Undergoing Surgery for Creation of an Arteriovenous Fistula for Hemodialysis Access
A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in improving the rate of AVF maturation and use in subjects with end-stage renal disease undergoing surgery for creation of an AVF to facilitate hemodialysis access.
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 Fistula
- Being tested
- SRM003, Participating Site's standard practice
- Keywords
- Arteriovenous Fistula Surgery, Vascular Injury, Hemodialysis Access
- Medical subject headings
- Arteriovenous Fistula, 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 (2 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 | One time implant (2 SRM003 pieces) on surgery day. Post-surgery, up to 26 weeks follow-up for assessment of efficacy/safety. Receives: Biological: SRM003 |
| Participating Site's standard practice | Other | Subjects will receive sites' standard practice treatment during the surgical procedure. 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 Arteriovenous Fistula (AVF) Maturation by Week 12 Visit Based on Hemodialysis or Color-flow Doppler Ultrasound (CDUS) And Vascular Access Examination
Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 12 visit without assessment of maturity were considered treatment failures.
Measured: 12 weeks after surgery
Secondary outcomes (8)
Percentage of Participants With AVF Maturation by Week 26 Visit Based on Hemodialysis or CDUS And Vascular Access Examination
Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 26 visit without assessment of maturity were considered treatment failures.
Measured: 26 weeks after surgery
Time to AVF Maturation Based on Hemodialysis or CDUS and Vascular Access Examination
Time to AVF maturation was defined as the duration of time (in days) from the date of randomization (AVF creation) to the date of maturation, where the date of maturation corresponds to the earlier of either the date of the first use of the study AVF for hemodialysis as determined by the investigator following discussion with the participant, or the date the AVF meets all of the following 3 criteria as determined through CDUS and vascular access examination: presence of bruit throughout systole and diastole at least 8 centimeters proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Participants who died, underwent a kidney transplant, or were either lost to follow-up or did not mature during the study follow-up were censored at the time of death, time of transplant, or time of last visit, respectively.
Measured: Up to 26 weeks after surgery
Percentage of Participants With Loss of Unassisted Primary Patency
The time to loss of unassisted primary patency (intervention--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) 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.
Measured: Up to 26 weeks after surgery
Percentage of Participants With Loss of Assisted Primary Patency
The time to loss of assisted primary patency (thrombosis--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) occlusion (commonly due to thrombosis) or (b) access abandonment.
Measured: Up to 26 weeks after surgery
Percentage of Participants With Loss of Secondary Patency
The time to loss of secondary patency (access survival until abandonment) was defined as the duration of time in days from the date of randomization (AVF creation) until the date of access abandonment.
Measured: Up to 26 weeks after surgery
Change From Week 1 in Average Vascular Access Lumen Diameter Using CDUS
B-mode lumen diameter measurements were obtained in the outflow vein as 3 separate images for each location: at 1, 3, and 5 centimeter into the vein and from the toe of the venous anastomosis. The average of lumen diameter measurements obtained at 1, 3, and 5 cm from the anastomosis was used for this endpoint.
Measured: 1, 12, and 26 weeks after surgery
Percentage of Participants With Clinical Success Based on First Use of The Study AVF For Hemodialysis
Clinical success was defined as the ability to undergo hemodialysis using the AVF. The date of clinical success corresponded to the date of the first use of the study AVF for hemodialysis as determined by the investigator, following discussion with the subject. Clinical success was assessed in a continuous fashion and, once achieved, the AVF was considered a clinical success at that and all subsequent time points. The date of clinical success based on the first use of the AVF for hemodialysis was compared with the dates of each study visit (Week 12 and Week 26); for study visits occurring prior to the date of clinical success based on the first use of the AVF for hemodialysis, the subject was counted as a nonsuccess and for study visits occurring on or after the date of maturation based on the first use of the AVF for hemodialysis, the subject was counted as a success.
Measured: 12 and 26 weeks after surgery
Number of Interventions to Establish, Maintain, or Restore Patency
The total number of interventions to establish, maintain, or restore patency was recorded for each participant.
Measured: 12 and 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 start26 Mar 2013
- Primary completion27 Oct 2014
- Study completion27 Oct 2014
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 FistulaStudies 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
- 64 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
- NCT01806545
- Sponsor's protocol ID
- AVF01-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 Improving the Rate of Arteriovenous Fistula Maturation and Use in Subjects Undergoing Surgery for Creation of an Arteriovenous Fistula for Hemodialysis Access
- ClinicalTrials.gov ID
- NCT01806545
- Acronym / sponsor ID
- AVF01-SRM003
- Conditions
- Arteriovenous Fistula
- Keywords
- Arteriovenous Fistula Surgery, Vascular Injury, Hemodialysis Access
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2013 (actual)
- Primary completion
- 27 Oct 2014 (actual)
- Study completion
- 27 Oct 2014 (actual)
- First posted
- 7 Mar 2013 (estimated)
- Results
- Posted 24 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 improving the rate of AVF maturation and use in subjects with end-stage renal disease undergoing surgery for creation of an AVF to facilitate hemodialysis access.
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: SRM003One time implant (2 SRM003 pieces) on surgery day. Post-surgery, up to 26 weeks follow-up for assessment of efficacy/safety. |
| Participating Site's standard practice | Other | Other: Participating Site's standard practiceSubjects will receive sites' standard practice treatment during the surgical procedure. |
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, suitable access for the AVF creation in the upper extremity.
- Subject must have a life expectancy of at least 26 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 26 weeks from surgery, or expects to receive a living donor organ or bone marrow within the next 26 weeks and is unwilling to change transplant list status to "hold" for 3 months after randomization.
- Subject has had more than 1 access placement surgery (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 (2 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 Arteriovenous Fistula (AVF) Maturation by Week 12 Visit Based on Hemodialysis or Color-flow Doppler Ultrasound (CDUS) And Vascular Access Examination
Time frame: 12 weeks after surgery
Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 12 visit without assessment of maturity were considered treatment failures.
8 secondary outcomes
Percentage of Participants With AVF Maturation by Week 26 Visit Based on Hemodialysis or CDUS And Vascular Access Examination
Time frame: 26 weeks after surgery
Time to AVF Maturation Based on Hemodialysis or CDUS and Vascular Access Examination
Time frame: Up to 26 weeks after surgery
Percentage of Participants With Loss of Unassisted Primary Patency
Time frame: Up to 26 weeks after surgery
Percentage of Participants With Loss of Assisted Primary Patency
Time frame: Up to 26 weeks after surgery
Percentage of Participants With Loss of Secondary Patency
Time frame: Up to 26 weeks after surgery
Change From Week 1 in Average Vascular Access Lumen Diameter Using CDUS
Time frame: 1, 12, and 26 weeks after surgery
Percentage of Participants With Clinical Success Based on First Use of The Study AVF For Hemodialysis
Time frame: 12 and 26 weeks after surgery
Number of Interventions to Establish, Maintain, or Restore Patency
Time frame: 12 and 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
47 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 Fistula, run by Shire at 47 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: finished, 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 47 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 24 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 Arteriovenous Fistula (AVF) Maturation by Week 12 Visit Based on Hemodialysis or Color-flow Doppler Ultrasound (CDUS) And Vascular Access Examination (time frame: 12 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.