Trial | NCT00074620  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    260
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.
Study Started
Nov 30
2003
Study Completion
Jan 31
2006
Last Update
Oct 05
2007
Estimate

Drug PEG-hirudin

Criteria 

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
No Results Posted