| Trial ID: | L0615 |
| Source ID: | NCT00210743
|
| Associated Drug: |
Epoetin Alfa
|
| Title: |
Alternate Dosing - Initiation of Every 2 Week Epoetin Alfa (PROCRIT) in the Treatment of Anemia.
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Anemia|Kidney Diseases
|
| Interventions: |
DRUG: epoetin alfa
|
| Outcome Measures: |
Primary: The primary endpoint is the number of subjects who achieve a hemoglobin response after receiving PROCRIT every 2 weeks. Hemoglobin response is defined as achieving a target hemoglobin range of 11-12 g/dL for at least 2 consecutive weeks by Week 28. | Secondary: The secondary endpoints include: the time to a hemoglobin response, the number of subjects achieving a 1 g/dL rise in hemoglobin, change in quality of life measurements, and the total study drug dose up to the time of response.
|
| Sponsor/Collaborators: |
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Collaborators: Ortho Biotech Products, L.P.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
67
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2004-05
|
| Completion Date: |
2005-10
|
| Results First Posted: |
|
| Last Update Posted: |
2011-05-23
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00210743
|
