| Trial ID: | L1023 |
| Source ID: | NCT00514813
|
| Associated Drug: |
Dynepo
|
| Title: |
Dynepo Long-Term Safety Study
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00514813/results
|
| Conditions: |
Anemia|Kidney Failure, Chronic
|
| Interventions: |
DRUG: Dynepo
|
| Outcome Measures: |
Primary: Rate of Emergence of Treatment Emergent Adverse Events (TEAEs), Over the course of 2 Years | Secondary: Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years, Baseline and 2 years|Change From Baseline in Hematocrits at 2 Years, Baseline and 2 years
|
| Sponsor/Collaborators: |
Sponsor: Shire
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
152
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
|
| Start Date: |
2007-06-06
|
| Completion Date: |
2008-07-31
|
| Results First Posted: |
2009-11-09
|
| Last Update Posted: |
2021-07-13
|
| Locations: |
Heilig Hartziekenhuis Department of Nephrology, Lier, Belgium
|
| URL: |
https://clinicaltrials.gov/show/NCT00514813
|
