A Phase 3 interventional study of Darbepoetin Alfa in Chronic Kidney Disease, sponsored by Amgen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-21.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the proportion of subjects sucessfully achieving a mean Hemoglobin greater than or equal to 11 g/dL during the evaluation period following extension from Weekly (QW) to Once Every Other Week (Q2W) Darbepoetin Alfa administraion.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 114 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 1,015 studies on the registry; 49 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.
Exclusion Criteria:
Drug: Darbepoetin Alfa
Administered IV or SC, Q2W at the following unit doses: 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200 or 300ug. Initial Q2W dose calculated from pre-enrollment QW doses. Doses titrated to achieve target Hb.
Haemoglobin values to be maintained at greater than 11.0 g/dL during the evaluation period.
Time frame: 33 weeks
Q2W doses over duration of study.
Time frame: 33 weeks
Hb values during the evaluation period.
Time frame: 33 weeks
adverse events during study
Time frame: 33 weeks
Hb Rate of Rise during study and excursions above 14g/dL
Time frame: 33 weeks
No study locations are listed for this record.
This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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Amgen