Trials / Completed
CompletedNCT00116701
Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis
A Study to Evaluate the Efficacy of Converting From Intravenous or Subcutaneous rHuEPO to Intravenous Darbepoetin Alfa (Aranesp®) in Subjects With Chronic Kidney Disease Receiving Haemodialysis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (planned)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Treatment period 1:To demonstrate that switching HD subjects with a baseline haemoglobin (Hb) ≥ 10 g/dL and ≤ 13 g/dL from either subcutaneous (SC) or intravenous (IV) rHuEPO to IV darbepoetin alfa results in a mean Hb \> 11 g/dL. Treatment Period 2:To demonstrate that switching subjects with a Hb \> 11 g/dL and ≤ 13 g/dL from once weekly IV darbepoetin alfa to once every 2 weeks (Q2W) maintains the mean Hb at \> 11 g/dL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aranesp® |
Timeline
- Start date
- 2005-05-01
- First posted
- 2005-07-01
- Last updated
- 2008-05-05
Source: ClinicalTrials.gov record NCT00116701. Inclusion in this directory is not an endorsement.