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.

First Received on December 17, 2003. Last Updated on October 4, 2007 History of Changes

Sponsor:	Speedel Pharma Ltd.
Collaborator:	Quintiles
Information provided by:	Speedel Pharma Ltd.
ClinicalTrials.gov Identifier:	NCT00074620

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 II

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:

MedlinePlus related topics: Blood Thinners Dialysis Kidney Failure

Drug Information available for: Hirudin Heparin

U.S. FDA Resources

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

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:

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 This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

The American Association of Kidney Patients helps kidney patients and their families deal with the physical, emotional and social impact of kidney diseases This link exits the ClinicalTrials.gov site

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 February 09, 2012