| Trial ID: | L0325 |
| Source ID: | NCT00116701
|
| Associated Drug: |
Aranesp®
|
| Title: |
Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Disease
|
| Interventions: |
DRUG: Aranesp®
|
| Outcome Measures: |
Primary: Treatment period 1: Mean haemoglobin during the evaluation period (weeks 21-24)|Treatment period 2: Mean haemoglobin during evaluation period 2 (weeks 45-48) | Secondary: Treatment period 2: Change in Hb between Evaluation Period 1 and Evaluation Period 2|Treatment period 2: The proportion of subjects with a change in Hb between Evaluation Period 1 and Evaluation Period 2 within the inclusive range -1.0 to +1.5 g/dL|Treatment period 2: The proportion of subjects with a mean Hb > 11.0 g/dL during Evaluation Period 2|Treatment period 2: Dose and frequency of darbepoetin alfa administration over the treatment period|Treatment period 1:The proportion of subjects with a mean Hb > 11.0 g/dL during the evaluation period|Treatment period 1: Change in Hb between screening/baseline and the evaluation period|Treatment period 1: Dose and frequency of darbepoetin alfa administration over the treatment period
|
| Sponsor/Collaborators: |
Sponsor: Amgen
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
200
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2005-05
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2008-05-05
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00116701
|
