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 have achieved and maintained target hemoglobin (Hb) on every 2 weeks (Q2W) dosing of darbepoetin alfa will have the dosing interval extended to once monthly (QM) dosing. Extending the dosing interval for darbepoetin alfa to QM represents a major potential benefit to both patients with CKD and their caregivers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
QM administration for 28 weeks, adjusted as necessary to maintain Hb between 11.0 - 13.0 g/dL PFS concentrations: 20, 30, 40, 50, 60, 80, 100, 150, 200 and 300 mcg.
The proportion of subjects on QM darbepoetin alfa dosing maintained with a mean Hb greater than or equal to 11.0 g/dL during the evaluation phase
Time frame: Entire Study
To determine Hb values over the duration of the study
Time frame: Entire Study
To determine darbepoetin alfa doses over the duration of the study
Time frame: Entire Study
To assess the safety of darbepoetin alfa
Time frame: Entire Study
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