Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use - Full Text View

Sponsored by:	Pervasis Therapeutics, Inc
Information provided by:	Pervasis Therapeutics, Inc
ClinicalTrials.gov Identifier:	NCT00479180

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 I Phase II

MedlinePlus related topics: Dialysis Fistulas Kidney Failure Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Official Title:	Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use

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 ]

Estimated Enrollment:	64
Study Start Date:	July 2006
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
AVG1: Experimental Vascugel	Biological: Vascugel One time implant on the day of surgery
AVG2: Placebo Comparator Gelfoam	Biological: Placebo Comparator One time implant on the day of surgery
AVF3: Experimental Vascugel	Biological: Vascugel One time implant on the day of surgery
AVF4: Placebo Comparator 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

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:	Pervasis Therapeutics ( Molly Rosano Director,Clinical Affairs )
Study ID Numbers:	PVS-06-003/06-004
Study First Received:	May 24, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00479180 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pervasis Therapeutics, Inc:

Hemodialysis access
Arteriovenous graft
Arteriovenous fistula
End stage renal disease

Study placed in the following topic categories:

Arteriovenous Fistula
Kidney Failure, Chronic
Kidney Diseases
Fistula

ClinicalTrials.gov processed this record on May 07, 2009