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

This study has been completed.
Sponsor:
Information provided by:
Pervasis Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00479180
First received: May 24, 2007
Last updated: October 25, 2011
Last verified: October 2011
  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

Resource links provided by NLM:


Further study details as provided by Pervasis Therapeutics, Inc:

Primary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479180

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Pervasis Therapeutics, Inc
  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 July 28, 2014