The proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients not on dialysis. Anemic patients who are not currently receiving ESA therapy will be dosed with darbepoetin alfa Q2W for 18 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Administration Q2W for 18 weeks. starting dose is 0.75 mcg/kg rounded to the nearest dose: 20, 30, 40, 50, 60, 80, 100, 150, 200 0r 300 mcg. Titrate to maintain Hb within 11.0 - 13.0 g/dL
The proportion of subjects achieving a Hb ≥ 11.0 g/dL
Time frame: Entire Study
Hb values over the duration of the study
Time frame: Entire Study
Darbepoetin alfa doses over the duration of the study
Time frame: Entire Study
Frequency, severity, and relationship to treatment for adverse events and changes in laboratory parameters and blood pressure
Time frame: Entire Study
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