The proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients on dialysis. Anemic patients on hemo and peritoneal dialysis who have achieved and maintained target hemoglobin (Hb) on every other week (Q2W) dosing of darbepoetin alfa will have the dosing interval extended to once monthly (QM) dosing.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
QM administration for 32 weeks, allowable doses: 15, 20, 30, 40, 50, 60, 80, 100, 150, 200, 300, 400, 500, 600 and 800 mcg
The proportion of subjects on QM darbepoetin alfa dosing maintained with a mean Hb greater than or equal to 11.0 g/dL and less than or equal to 13.0 g/dL during the evaluation phase
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 and relationship to treatment for adverse events and changes in laboratory parameters and blood pressure
Time frame: entire study
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