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

Chronic Kidney Failure Clinical Trial

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 Haemodialysis Via an Arteriovenous Graft

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00074620
• Other study ID #: SPP200CRD01
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2003
• Last updated: October 4, 2007
• Start date: November 2003
• Est. completion date: January 2006

Study information

• Verified date: October 2007
• Source: Speedel Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

• Patients undergoing chronic haemodialysis via an arteriovenous graft

• Arteriovenous graft in place for at least 3 months

• Duration of haemodialysis of at least 3 months, with 3 full dialysis sessions per week with a duration between 2 and 5 hours per session

• Women patients must be either postmenopausal for more than 1 year or, if of childbearing age, must use adequate contraception

• Women patients must have a negative serum pregnancy test within one week of randomisation

• Able to provide written informed consent prior to study participation

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Kidney Failure
• Graft Occlusion, Vascular
• Kidney Failure, Chronic
• Renal Insufficiency
• Vascular Graft Occlusion

Intervention

Drug:
• PEG-hirudin

Locations

Country	Name	City	State
United States	Pennsylvania Hospital - Franklin Dialysis Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Speedel Pharma Ltd.	Quintiles, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety and tolerability of SPP200 in patients undergoing chronic haemodialysis via an arteriovenous graft.
Secondary	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.

External Links

•   The American Association of Kidney Patients helps kidney patients and their families deal with the physical, emotional and social impact of kidney diseases
•   The National Kidney Foundation is a voluntary organisation which seeks to prevent kidney diseases, improve the health of patients and increase the availability of organs for transplantation