| Trial ID: | L0782 |
| Source ID: | NCT01739660
|
| Associated Drug: |
Pegloticase
|
| Title: |
Study to Assess Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease Stage 5
|
| Interventions: |
DRUG: Pegloticase
|
| Outcome Measures: |
Primary: • To evaluate the pharmacokinetics (PK) of pegloticase after a single-dose administration to hemodialysis patients when administered starting 3 hours before dialysis, 1 month | Secondary: • To evaluate the pharmacodynamics (PD) of pegloticase and SUA, before and after hemodialysis sessions, 1 month
|
| Sponsor/Collaborators: |
Sponsor: Savient Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
12
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose:
|
| Start Date: |
2012-12
|
| Completion Date: |
2013-04
|
| Results First Posted: |
|
| Last Update Posted: |
2013-10-25
|
| Locations: |
Davita Clinical Research, Minneapolis, Minnesota, 55404, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01739660
|
