Clinical Trial: A Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomised, Multicenter, Open-Label, Parallel Group Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Unfractionated Heparin as Anticoagulant Treatment in Patients Undergoing Haemodialy

Brief Summary: The study will look at the safety profile (unwanted effects) of the long-lasting anticoagulant PEG-hirudin (SPP200) and compare these unwanted effects to those of unfractionated heparin, commonly used in haemodialysis to avoid clotting of the graft and of the haemodialysis machine.

Detailed Summary:
Sponsor: Speedel Pharma Ltd.

Current Primary Outcome: To determine the safety and tolerability of SPP200 in patients undergoing chronic haemodialysis via an arteriovenous graft.

Original Primary Outcome: Same as current

Current Secondary Outcome: To determine the efficacy of PEG-hirudin compared to unfractionated heparin (UFH) on the frequency of vascular graft occlusions and on time to first graft occlusions.

Original Secondary Outcome: Same as current

Information By: Speedel Pharma Ltd.

Dates:
Date Received: December 17, 2003
Date Started: November 2003
Date Completion: January 2006
Last Updated: October 4, 2007
Last Verified: October 2007