NCT01806545

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

A Phase 2, Single-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy and Safety of SRM003 (Vascugel®) in Improving the Rate of Arteriovenous Fistula Maturation and Use in Subjects Undergoing Surgery for Creation of an Arteriovenous Fistula for Hemodialysis Access

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (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 improving the rate of AVF maturation and use in subjects with end-stage renal disease undergoing surgery for creation of an AVF to facilitate hemodialysis access. 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 Fistula

Interventions

Type	Name	Description
BIOLOGICAL	SRM003	One time implant (2 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: 2013-03-26
• Primary completion: 2014-10-27
• Completion: 2014-10-27
• First posted: 2013-03-07
• Last updated: 2021-06-08
• Results posted: 2015-12-24

Locations

47 sites across 1 country: United States