| Trial ID: | L0442 |
| Source ID: | NCT00212875
|
| Associated Drug: |
Epoetin Alfa
|
| Title: |
A Study of Four Dosing Regimens of PROCRIT (Epoetin Alfa) in Patients With Chronic Kidney Disease. Protocol Addendum: Extension Study of Maintenance Therapy of PROCRIT (Epoetin Alfa) in Patients With Chronic Kidney Disease.
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease|Anemia
|
| Interventions: |
DRUG: epoetin alfa
|
| Outcome Measures: |
Primary: Change in hemoglobin (Hb) from baseline to the end of the study; Primarily interested in the change in Hb between Q2W vs Q4W groups. Protocol Addendum: Hb change from baseline to end of open-label extension (no more than 36 weeks) | Secondary: Hb response (defined as achieving a Hb increase =>1g/dL from baseline any time during study); Change in Hb over time; Treatment failures; Blood transfused; Epoetin alfa dose when Hb is achieved and at study end.
|
| Sponsor/Collaborators: |
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Collaborators: Centocor Ortho Biotech Services, L.L.C.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
267
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2005-09
|
| Completion Date: |
2007-02
|
| Results First Posted: |
|
| Last Update Posted: |
2011-05-23
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00212875
|
