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:
Collaborator:
Quintiles
Information provided by:
Speedel Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT00074620
First received: December 17, 2003
Last updated: October 4, 2007
Last verified: October 2007
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074620

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00074620     History of Changes
Other Study ID Numbers: SPP200CRD01
Study First Received: December 17, 2003
Last Updated: October 4, 2007
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 14, 2014