| Trial ID: | L0420 |
| Source ID: | NCT00641589
|
| Associated Drug: |
Epoetin Alfa
|
| Title: |
A Study to Determine the Pharmacokinetic and Pharmacodynamic Profiles of PROCRIT (Epoetin Alfa) in Anemic Patients With Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease|Anemia
|
| Interventions: |
DRUG: epoetin alfa
|
| Outcome Measures: |
Primary: The primary objective of the study is to describe the pharmacokinetic (PK) profiles of 4 different dosing regimens of PROCRIT in patients with anemia secondary to chronic kidney disease (CKD) not on dialysis. | Secondary: The secondary objective is to describe the pharmacodynamic (PD) response to the four PROCRIT study dosing regimens using the following outcomes: absolute and % reticulocyte count, hemoglobin (Hb), hematocrit (Hct), and red blood cell (RBC) count.
|
| 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: |
PHASE1
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-01
|
| Completion Date: |
2006-11
|
| Results First Posted: |
|
| Last Update Posted: |
2011-05-18
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00641589
|
