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

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.

Sponsors and Collaborators:	Speedel Pharma Ltd. 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

MedlinePlus related topics:

Dialysis Kidney Failure

ChemIDplus related topics:

Heparin Hirudin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

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

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

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

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

Keywords provided by Speedel Pharma Ltd.:

Haemodialysis

PEG-Hirudin

Vascular graft occlusion

Renal replacement therapy

Hemodialysis

Study placed in the following topic categories:

Renal Insufficiency

Graft Occlusion, Vascular

Urologic Diseases

Postoperative Complications

Renal Insufficiency, Chronic

Heparin, Low-Molecular-Weight

Kidney Failure, Chronic

Kidney Diseases

Heparin

Hirudins

Calcium heparin

Kidney Failure

Additional relevant MeSH terms:

Fibrin Modulating Agents

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Hematologic Agents

Fibrinolytic Agents

Enzyme Inhibitors

Cardiovascular Agents

Pharmacologic Actions

Protease Inhibitors

ClinicalTrials.gov processed this record on October 10, 2008