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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Hemodialysis Access

In brief

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.

Key facts

Study ID

NCT00479180

Run by

Pervasis Therapeutics, Inc

People needed

65

Starts

2006-07-01

Expected to finish

2010-06-01

Last updated by the study team

2011-10-27

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult male or female patients (ages of 18 to 89, inclusive) who are undergoing placement of an AV graft or fistula for hemodialysis access

You may not qualify if…

• 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.

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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