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

Phase 2

Completed

• Conditions: Chronic Kidney Failure; Vascular Graft Occlusion

• Registration Number: NCT00074620
• Lead Sponsor: Speedel Pharma Ltd.

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 Description

Not available

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2003-12-17
• Study First Submitted QC: 2003-12-18
• Study First Posted: 2003-12-19
• Study Completion: 2006-01
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-04
• Last Update Posted: 2007-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To determine the safety and tolerability of SPP200 in patients undergoing chronic haemodialysis via an arteriovenous graft.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pennsylvania Hospital - Franklin Dialysis Center; 🇺🇸 Philadelphia, Pennsylvania, United States