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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00074620
First Posted: December 19, 2003
Last Update Posted: October 5, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Quintiles, Inc.
Information provided by:
Speedel Pharma Ltd.
  Purpose
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.

Condition Intervention Phase
Chronic Kidney Failure Vascular Graft Occlusion Drug: PEG-hirudin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Speedel Pharma Ltd.:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 260
Study Start Date: November 2003
Estimated Study Completion Date: January 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00074620


Locations
United States, Pennsylvania
Pennsylvania Hospital - Franklin Dialysis Center
Philadelphia, Pennsylvania, United States, 19106
Sponsors and Collaborators
Speedel Pharma Ltd.
Quintiles, Inc.
Investigators
Study Chair: Jessica M Mann, MD, PhD Speedel Bio Ltd
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00074620     History of Changes
Other Study ID Numbers: SPP200CRD01
First Submitted: December 17, 2003
First Posted: December 19, 2003
Last Update Posted: October 5, 2007
Last Verified: October 2007

Keywords provided by Speedel Pharma Ltd.:
Haemodialysis
PEG-Hirudin
Vascular graft occlusion
Renal replacement therapy
Hemodialysis

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Graft Occlusion, Vascular
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Postoperative Complications
Pathologic Processes
Heparin
Hirudins
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors