drugset / Trial / NCT00096915
Study Evaluating Darbepoetin Alfa in Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients on dialysis. Anemic patients on hemo and peritoneal dialysis who have achieved and maintained target hemoglobin (Hb) on every other week (Q2W) dosing of darbepoetin alfa will have the dosing interval extended to once monthly (QM) dosing.
Timeline
- Start
- 2004-10
- Primary completion
- 2005-11
- Completion
- 2005-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 400 ug | — |
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 500 ug | — |
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 600 ug | — |
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 800 ug | — |