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

Arteriovenous Graft Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Arteriovenous Graft

Clinical Trial Details

NCT number	NCT01806584
Study type	Interventional
Source	Takeda
Contact
Status	Terminated
Phase	Phase 2
Start date	March 28, 2013
Completion date	October 23, 2014

View Details

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