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

Pervasis Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hemodialysis Access

Treatments: Biological: Vascugel; Biological: Placebo Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00479180

PVS-06-003/06-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 4 patient groups, including a placebo group

AVG1

Experimental group

Description:

Vascugel

Treatment:

Biological: Vascugel

AVG2

Placebo Comparator group

Description:

Gelfoam

Treatment:

Biological: Placebo Comparator

AVF3

Experimental group

Description:

Vascugel

Treatment:

Biological: Vascugel

AVF4

Placebo Comparator group

Description:

Gelfoam

Treatment:

Biological: Placebo Comparator