Back to resultsA Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis
Primary Purpose
Chronic Kidney Failure, Vascular Graft Occlusion
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PEG-hirudin
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Failure focused on measuring Haemodialysis, PEG-Hirudin, Vascular graft occlusion, Renal replacement therapy, Hemodialysis
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
Sites / Locations
- Pennsylvania Hospital - Franklin Dialysis Center
Outcomes
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.
Full Information
NCT ID
NCT00074620
First Posted
December 17, 2003
Last Updated
October 4, 2007
Sponsor
Speedel Pharma Ltd.
Collaborators
Quintiles, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00074620
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Speedel Pharma Ltd.
Collaborators
Quintiles, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Failure, Vascular Graft Occlusion
Keywords
Haemodialysis, PEG-Hirudin, Vascular graft occlusion, Renal replacement therapy, Hemodialysis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
PEG-hirudin
Primary Outcome Measure Information:
Title
To determine the safety and tolerability of SPP200 in patients undergoing chronic haemodialysis via an arteriovenous graft.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica M Mann, MD, PhD
Organizational Affiliation
Speedel Bio Ltd
Official's Role
Study Chair
Facility Information:
Facility Name
Pennsylvania Hospital - Franklin Dialysis Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.kidney.org/
Description
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
URL
http://www.aakp.org/
Description
The American Association of Kidney Patients helps kidney patients and their families deal with the physical, emotional and social impact of kidney diseases
Learn more about this trial
A Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis
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