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

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

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• 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.

Contacts and Locations

Locations

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Pervasis Therapeutics, Inc

More Information

• Responsible Party: Elizabeth Merica, Director,Clinical Affairs, Pervasis Therapeutics
• ClinicalTrials.gov Identifier: NCT00479180
• Other Study ID Numbers: PVS-06-003/06-004
• First Posted: May 28, 2007
• 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