| Trial ID: | L1221 |
| Source ID: | NCT00527137
|
| Associated Drug: |
Darbepoetin Alfa
|
| Title: |
NESP Pediatric Study
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Pre-dialysis|End Stage Renal Disease
|
| Interventions: |
DRUG: darbepoetin alfa|DRUG: rHuEPO
|
| Outcome Measures: |
Primary: To demonstrate that NESP is comparable (not inferior) to rHuEPO for the treatment of anemia in pediatric subjects with CRI or ESRD receiving dialysis, Entire Study | Secondary: To determine the safety and tolerability of NESP in the treatment of anemia in the pediatric population with CRI or ESRD, Entire Study
|
| Sponsor/Collaborators: |
Sponsor: Amgen
|
| Gender: |
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
120
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2000-08
|
| Completion Date: |
2004-11
|
| Results First Posted: |
|
| Last Update Posted: |
2013-05-08
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00527137
|
