drugset / Trial / NCT00116701

Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis

NCT00116701

Phase 3 Completed 200 enrolled Amgen
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

EvaluationDrugModalityDoseRoute
Subject Darbepoetin alfa Protein / enzyme biologic Intravenous