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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
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
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