A Phase 3 interventional study of darbepoetin alfa SF in Kidney Disease and Chronic Kidney Disease, sponsored by Amgen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-24.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 1,100 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Amgen is the lead sponsor of 1,016 studies on the registry; 50 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Drug: darbepoetin alfa SF
Frequency of dosing depends on frequency at randomization: rHuEPO QW = darbepoetin alfa SF Q2W (dosing conversion table in protocol) rHuEPO biw or tiw = darbepoetin alfa SF QW (dosing conversion table in protocol) darbepoetin alfa RB = darbepoetin alfa SF at same dose and frequency PFS 10, 15, 20, 30, 40, 50, 60, 80, 100, 150, 200 or 300 mcg; Hb maintained between 11.0 - 13.0 g/dL
To determine whether darbepoetin alfa manufactured by a roler bottle technology (darbepoetin alfa RB) and darbepoetin alfa manufactured by a serum free process (darbepoetin alfa SF) have a comparable safety profile
Time frame: Entire Study
To characterize laboratory parameters in subjects with CKD
Time frame: Entire Study
No study locations are listed for this record.
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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Amgen