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NCT00074620 Clinical Trial

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
Secondary ID
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
Est. primary completion date
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

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.
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