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Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use

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ClinicalTrials.gov Identifier: NCT00479180
Recruitment Status : Completed
First Posted : May 28, 2007
Last Update Posted : October 27, 2011
Sponsor:
Information provided by:
Pervasis Therapeutics, Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Hemodialysis Access Biological: Vascugel Biological: Placebo Comparator Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use
Study Start Date : July 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Safety of vascugel [ Time Frame: 6 months followed by 2.5 year extension ]


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479180


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Pervasis Therapeutics, Inc

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
First Posted: May 28, 2007    Key Record Dates
Last Update Posted: October 27, 2011
Last Verified: October 2011

Keywords provided by Pervasis Therapeutics, Inc:
Hemodialysis access
Arteriovenous graft
Arteriovenous fistula
End stage renal disease