| Trial ID: | L0080 |
| Source ID: | NCT00307814
|
| Associated Drug: |
Epoetin Alfa
|
| Title: |
A Study to Evaluate PROCRIT (Epoetin Alfa) for Maintenance Phase Treatment of Patients With Anemia Due to Chronic Kidney Disease (PROMPT)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Anemia|Chronic Renal Insufficiency
|
| Interventions: |
DRUG: Epoetin Alfa
|
| Outcome Measures: |
Primary: The primary efficacy variable is hemoglobin maintenance. Also, patients will be assessed for incidence and severity of adverse events and vital signs (blood pressure) during the 16 week study period. | Secondary: The secondary variable is Quality of Life and Hemoglobin Change over Time
|
| Sponsor/Collaborators: |
Sponsor: Ortho Biotech Products, L.P.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
519
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2002-01
|
| Completion Date: |
2004-01
|
| Results First Posted: |
|
| Last Update Posted: |
2011-05-19
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00307814
|
