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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 17, 2003

Last Updated Date

October 4, 2007

Start Date ^†

November 2003

Current Primary Outcome Measures ^†

To determine the safety and tolerability of SPP200 in patients undergoing chronic haemodialysis via an arteriovenous graft.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00074620 on ClinicalTrials.gov Archive Site

Current 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.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Condition ^†

Chronic Kidney Failure
Vascular Graft Occlusion

Intervention ^†

Drug: PEG-hirudin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

260

Completion Date

January 2006

Primary Completion Date

Eligibility 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

Gender

Both

Ages

21 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00074620

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Speedel Pharma Ltd.

Collaborators ^††

Quintiles

Investigators ^†

Study Chair:

Jessica M Mann, MD, PhD

Speedel Bio Ltd

Information Provided By

Speedel Pharma Ltd.

Verification Date

October 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.