OBJECTIVES: To evaluate the efficacy of once-monthly darbepoetin alfa in maintaining hemoglobin (Hb) levels between 10 and 12 g/dL in older subjects receiving darbepoetin alfa every 2 weeks. DESIGN: A secondary analysis of a 29-week multicenter, open-label, single-arm study with an initial 2-week screening/baseline period, followed by a 20-week once-monthly darbepoetin alfa dose titration period and an 8-week evaluation period. SETTING: Twenty treatment centers in the United States. PARTICIPANTS: Subjects with CKD who were not receiving dialysis and whose hemoglobin levels were > or =10 g/dL with darbepoetin alfa every 2 weeks. INTERVENTION: Darbepoetin alfa administered once monthly and titrated to maintain Hb level between 10 and 12 g/dL, inclusive. MEASUREMENTS: The proportion of subjects maintaining a mean Hb concentration of 10 to 12 g/dL, inclusive, while receiving once-monthly darbepoetin alfa during the evaluation period (weeks 21 to 29); the mean change in Hb levels and darbepoetin alfa doses between baseline and the evaluation period; and the treatment relationship, frequency, severity, and outcomes of all adverse events. Analyses were stratified by age (<65, > or =65, and > or =75 years). RESULTS: Seventy-nine percent of subjects aged > or =65 years and 80% of subjects aged > or =75 years maintained their Hb levels within the specified target range, compared with 80% of subjects aged <65 years who maintained their Hb levels within the specified target range. Hemoglobin levels and darbepoetin alfa doses did not change significantly from baseline to the evaluation period. Darbepoetin alfa administered once monthly was well tolerated in all age groups. CONCLUSION: Darbepoetin alfa administered once monthly effectively maintained target Hb levels in older subjects with CKD (not receiving dialysis) who were maintained previously with an every 2 weeks darbepoetin alfa regimen.
OBJECTIVES: To evaluate the efficacy of once-monthly darbepoetin alfa in maintaining hemoglobin (Hb) levels between 10 and 12 g/dL in older subjects receiving darbepoetin alfa every 2 weeks. DESIGN: A secondary analysis of a 29-week multicenter, open-label, single-arm study with an initial 2-week screening/baseline period, followed by a 20-week once-monthly darbepoetin alfa dose titration period and an 8-week evaluation period. SETTING: Twenty treatment centers in the United States. PARTICIPANTS: Subjects with CKD who were not receiving dialysis and whose hemoglobin levels were > or =10 g/dL with darbepoetin alfa every 2 weeks. INTERVENTION: Darbepoetin alfa administered once monthly and titrated to maintain Hb level between 10 and 12 g/dL, inclusive. MEASUREMENTS: The proportion of subjects maintaining a mean Hb concentration of 10 to 12 g/dL, inclusive, while receiving once-monthly darbepoetin alfa during the evaluation period (weeks 21 to 29); the mean change in Hb levels and darbepoetin alfa doses between baseline and the evaluation period; and the treatment relationship, frequency, severity, and outcomes of all adverse events. Analyses were stratified by age (<65, > or =65, and > or =75 years). RESULTS: Seventy-nine percent of subjects aged > or =65 years and 80% of subjects aged > or =75 years maintained their Hb levels within the specified target range, compared with 80% of subjects aged <65 years who maintained their Hb levels within the specified target range. Hemoglobin levels and darbepoetin alfa doses did not change significantly from baseline to the evaluation period. Darbepoetin alfa administered once monthly was well tolerated in all age groups. CONCLUSION: Darbepoetin alfa administered once monthly effectively maintained target Hb levels in older subjects with CKD (not receiving dialysis) who were maintained previously with an every 2 weeks darbepoetin alfa regimen.