Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hemodialysis Access |
Biological: Vascugel Biological: Placebo Comparator |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use |
- Safety of vascugel [ Time Frame: 6 months followed by 2.5 year extension ] [ Designated as safety issue: Yes ]
| Enrollment: | 65 |
| Study Start Date: | July 2006 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AVG1
Vascugel
|
Biological: Vascugel
One time implant on the day of surgery
|
|
Placebo Comparator: AVG2
Gelfoam
|
Biological: Placebo Comparator
One time implant on the day of surgery
|
|
Experimental: AVF3
Vascugel
|
Biological: Vascugel
One time implant on the day of surgery
|
|
Placebo Comparator: AVF4
Gelfoam
|
Biological: Placebo Comparator
One time implant on the day of surgery
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult male or female patients (ages of 18 to 89, inclusive) who are undergoing placement of an AV graft or fistula for hemodialysis access
Exclusion Criteria:
- 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Elizabeth Merica, Director,Clinical Affairs, Pervasis Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00479180 History of Changes |
| Other Study ID Numbers: | PVS-06-003/06-004 |
| Study First Received: | May 24, 2007 |
| Last Updated: | October 25, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pervasis Therapeutics, Inc:
|
Hemodialysis access Arteriovenous graft Arteriovenous fistula End stage renal disease |
ClinicalTrials.gov processed this record on June 18, 2013