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

Hemodialysis Access Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00479180
• Other study ID #: PVS-06-003/06-004
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 24, 2007
• Last updated: October 25, 2011
• Start date: July 2006
• Est. completion date: June 2010

Study information

• Verified date: October 2011
• Source: Pervasis Therapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis Access

Intervention

Biological:
• Vascugel
One time implant on the day of surgery
• Placebo Comparator
One time implant on the day of surgery

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Pervasis Therapeutics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of vascugel		6 months followed by 2.5 year extension	Yes