| Trial ID: | L1458 |
| Source ID: | NCT00074620
|
| Associated Drug: |
Peg-Hirudin
|
| Title: |
A Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Failure|Vascular Graft Occlusion
|
| Interventions: |
DRUG: PEG-hirudin
|
| Outcome Measures: |
Primary: To determine the safety and tolerability of SPP200 in patients undergoing chronic haemodialysis via an arteriovenous graft. | Secondary: 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.
|
| Sponsor/Collaborators: |
Sponsor: Speedel Pharma Ltd. | Collaborators: Quintiles, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
260
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2003-11
|
| Completion Date: |
2006-01
|
| Results First Posted: |
|
| Last Update Posted: |
2007-10-05
|
| Locations: |
Pennsylvania Hospital - Franklin Dialysis Center, Philadelphia, Pennsylvania, 19106, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00074620
|
