NCT01806584

An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Placement of an Arteriovenous Graft to Facilitate Hemodialysis Access

A Phase 2, Single-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy and Safety of SRM003 (Vascugel®) in the Treatment of Subjects With Vascular Injury Resulting From Arteriovenous Graft Surgery for Hemodialysis Access

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in extending the duration of primary patency after arteriovenous graft surgery in subjects with end-stage renal disease. It is hypothesized that when placed outside the blood vessel, the seeded SRM003 gelatin matrix containing endothelial cells can provide a continuous supply of multiple growth regulatory compounds to the underlying cells within the blood vessel, while being protected from the effects of blood flow in the vessel(s) or complications resulting from being in direct contact with the point of injury.

Conditions

• Arteriovenous Graft

Interventions

Type	Name	Description
BIOLOGICAL	SRM003	One time implant (3 SRM003 pieces) on surgery day.
OTHER	Participating Site's standard practice	Subjects will receive sites' standard practice treatment during the surgical procedure

Timeline

• Start date: 2013-03-28
• Primary completion: 2014-10-23
• Completion: 2014-10-23
• First posted: 2013-03-07
• Last updated: 2021-06-08
• Results posted: 2015-12-31

Locations

46 sites across 1 country: United States