drugset / Trial / NCT00093977
Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine whether darbepoetin alfa manufactured by the current "roller bottle" technology and darbepoetin alfa manufactured by a serum free process have a comparable safety profile.
Timeline
- Start
- 2004-10
- Primary completion
- 2007-01
- Completion
- 2007-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 10 ug | — |
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 15 ug | — |
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 20 ug | — |
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 30 ug | — |
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 40 ug | — |
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 50 ug | — |
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 60 ug | — |
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 80 ug | — |
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 100 ug | — |
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 150 ug | — |
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 200 ug | — |
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 300 ug | — |