drugset / Trial / NCT00116701
Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2005-05
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darbepoetin alfa | Protein / enzyme biologic | — | Intravenous |