drugset / Trial / NCT00527215
Phase 2 Study of Darbepoetin Alfa Extended Dosing
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Multicenter, open label single arm study in which 140 subjects with CRI who are currently receiving SC darbepoetin alfa once every other week will receive darbepoetin alfa once every 4 weeks for 24 weeks. Upon enrollment into this study, subjects will receive darbepoetin alfa once every 4 weeks for 24 weeks. The initial dose will be equivalent to the subject's total dose in the month preceding enrollment. Doses may be titrated to maintain the Hb concentration in the target range.
Timeline
- Start
- 2002-03
- Primary completion
- 2003-10
- Completion
- 2003-10
Publications
- Results Ling B, Walczyk M, Agarwal A, Carroll W, Liu W, Brenner R. Darbepoetin alfa administered once monthly maintains hemoglobin concentrations in patients with chronic kidney disease. Clin Nephrol. 2005 May;63(5):327-34. doi: 10.5414/cnp63327.
- Results Agarwal A, Silver MR, Walczyk M, Liu W, Audhya P. Once-monthly darbepoetin alfa for maintaining hemoglobin levels in older patients with chronic kidney disease. J Am Med Dir Assoc. 2007 Feb;8(2):83-90. doi: 10.1016/j.jamda.2006.07.007. Epub 2006 Sep 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darbepoetin alfa | Protein / enzyme biologic | — | Subcutaneous |
Indications
No indication recorded.