Hemodialysis AccessPhase 1/2NCT00479180
Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use
A Phase 1/2 study testing Vascugel in people with Hemodialysis Access, run by Pervasis Therapeutics, Inc at 1 site in United States.
Trial summary
Vascugel™ is safe when placed at the anastomotic site at the time of surgery during creation of an AV graft or fistula for hemodialysis access. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hemodialysis Access
- What is being tested?
- Vascugel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jun 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female patients (ages of 18 to 89, inclusive) who are undergoing placement of an AV graft or fistula for hemodialysis access
Who cannot join
- Patient is currently on an active transplant list for a kidney from a deceased donor OR is undergoing assessment and expects to be placed on the active transplant list within the next twenty-four weeks OR expects to receive a living donor kidney within twenty-four weeks.
- Patient is expecting another solid organ transplant or a bone marrow transplant.
- Patient has had more than one access surgery (defined as a new access, not a revision) in the target limb.
- Patient is currently on chronic, systemic immunosuppressant medication other than locally or topically applied steroids.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Vascugel™ is safe when placed at the anastomotic site at the time of surgery during creation of an AV graft or fistula for hemodialysis access.
Read the detailed description
Randomized, double-blind, parallel group, Phase I/II clinical trial of Vascugel™ treatment vs. Gelfoam® in patients undergoing creation of an arteriovenous graft or fistula for hemodialysis access.
All patients will undergo preoperative duplex ultrasound imaging and/or angiography (whatever is the standard of care at the research site) of the vein and artery to evaluate the optimal site for vascular access placement in the upper extremity.
Patients will be examined with Doppler ultrasound or standard of care immediately after surgery to verify patency of the AV graft or fistula.
During the follow-up period, each patient will undergo a physical examination and imaging of the vascular access at specified intervals.
- Conditions
- Hemodialysis Access
- Being tested
- Vascugel, Placebo Comparator
- Keywords
- Hemodialysis access, Arteriovenous graft, Arteriovenous fistula, End stage renal disease
- Medical subject headings
- Arteriovenous Fistula, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VascugelBiological
One time implant on the day of surgery
Placebo ComparatorBiological
One time implant on the day of surgery
| Study group | Role | What they receive |
|---|---|---|
| AVG1 | Experimental | Vascugel Receives: Biological: Vascugel |
| AVG2 | Placebo comparator | Gelfoam Receives: Biological: Placebo Comparator |
| AVF3 | Experimental | Vascugel Receives: Biological: Vascugel |
| AVF4 | Placebo comparator | Gelfoam Receives: Biological: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of vascugel
Measured: 6 months followed by 2.5 year extension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2007 (estimated)
- Study startJul 2006
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis AccessStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pervasis Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00479180
- Sponsor's protocol ID
- PVS-06-003/06-004
- Status last verified
- Oct 2011
- First submitted
- 24 May 2007
- Last updated
- 27 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use
- ClinicalTrials.gov ID
- NCT00479180
- Acronym / sponsor ID
- PVS-06-003/06-004
- Conditions
- Hemodialysis Access
- Keywords
- Hemodialysis access, Arteriovenous graft, Arteriovenous fistula, End stage renal disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Pervasis Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 28 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vascugel™ is safe when placed at the anastomotic site at the time of surgery during creation of an AV graft or fistula for hemodialysis access.
Detailed description
Randomized, double-blind, parallel group, Phase I/II clinical trial of Vascugel™ treatment vs. Gelfoam® in patients undergoing creation of an arteriovenous graft or fistula for hemodialysis access.
All patients will undergo preoperative duplex ultrasound imaging and/or angiography (whatever is the standard of care at the research site) of the vein and artery to evaluate the optimal site for vascular access placement in the upper extremity.
Patients will be examined with Doppler ultrasound or standard of care immediately after surgery to verify patency of the AV graft or fistula.
During the follow-up period, each patient will undergo a physical examination and imaging of the vascular access at specified intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AVG1 | Experimental | Biological: VascugelVascugel |
| AVG2 | Placebo comparator | Biological: Placebo ComparatorGelfoam |
| AVF3 | Experimental | Biological: VascugelVascugel |
| AVF4 | Placebo comparator | Biological: Placebo ComparatorGelfoam |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult male or female patients (ages of 18 to 89, inclusive) who are undergoing placement of an AV graft or fistula for hemodialysis access
Key exclusion criteria (4 listed)
- Patient is currently on an active transplant list for a kidney from a deceased donor OR is undergoing assessment and expects to be placed on the active transplant list within the next twenty-four weeks OR expects to receive a living donor kidney within twenty-four weeks.
- Patient is expecting another solid organ transplant or a bone marrow transplant.
- Patient has had more than one access surgery (defined as a new access, not a revision) in the target limb.
- Patient is currently on chronic, systemic immunosuppressant medication other than locally or topically applied steroids.
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 |
|---|---|---|
| VascugelOne time implant on the day of surgery | Biological | AVF3, AVG1 |
| Placebo ComparatorOne time implant on the day of surgery | Biological | AVF4, AVG2 |
Primary outcome
Safety of vascugel
Time frame: 6 months followed by 2.5 year extension
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vascugel in people with Hemodialysis Access, run by Pervasis Therapeutics, Inc at 1 site 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 1 inclusion and 4 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 27 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety of vascugel (time frame: 6 months followed by 2.5 year extension). 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 27 Oct 2011.