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:
Speedel Pharma Ltd.
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 16, 2013