Abstract
Background: New erythropoiesis-stimulating agents (ESAs) with a longer half-life have been developed for the treatment of anemia as a complication of patients with end-stage renal disease. Objectives: The objective of the present study was to assess the hemoglobin (Hb) stability of a Japanese cohort of hemodialysis (HD) patients who were simultaneously switched from darbepoetin alfa (DA) to epoetin beta pegol (CERA). Methods: This was an observational, prospective study of HD patients 20 years of age or more who were switched from intravenous (IV) DA to IV CERA and continued on HD for at least 3 months. The dose was adjusted to maintain the Hb level to within 1.0 g/dl of the baseline value. Results: A total of 68 HD patients (75.0% male, median age 63.0 years) were enrolled. The patients’ mean Hb levels were 10.8 ± (0.6) g/dl at Month 0, 10.9 ± 0.7 at Month 1, 10.8 ± 0.7 at Month 2, and 10.9 ± 0.8 at Month 3, and the differences from the level at Month 0 were not significant. After the switch, the ESA dose decreased significantly (P P < 0.0001). Conclusion: Switching from DA to CERA was associated with approximate 89% reduction of the required dose in Japanese HD patients being treated with an ESA and showed a favorable impact on the treatment of renal anemia, including the need for less frequent injections and a reduction of the ESA dose.
Highlights
Since renal anemia is a complication of advanced chronic kidney disease (CKD), administration of erythropoiesis-stimulating agents (ESAs) has led to a great improvement in clinical management [1], because ESA treatment significantly reduces the need for transfusions, hospital admissions, and overall mortality [2]-[4]
There were no significant changes in serum ferritin levels during the follow-up period (Figure 4(a)), but temporal changes in transferrin saturation (TSAT) (Figure 4(b)) were observed during the follow-up period, suggesting that there was no change in iron metabolism after switching from darbepoetin alfa (DA) to Continuous erythropoietin receptor activator (CERA)
The CERA dose gradually decreased from 549.0 ± 246.6 IU/kg/month at the baseline to 491.0.0 ± 291.7 IU/kg/month (89%) during the follow-up period. This finding is evidence that CERA should be started at approximately 80% - 90% of the DA dose to maintain equivalent Hb levels when the switching ESA from DA to CERA, suggesting that the CERA dose is reducible during the maintenance phase of the CERA therapy [17]
Summary
Since renal anemia is a complication of advanced chronic kidney disease (CKD), administration of erythropoiesis-stimulating agents (ESAs) has led to a great improvement in clinical management [1], because ESA treatment significantly reduces the need for transfusions, hospital admissions, and overall mortality [2]-[4]. The first ESA available for clinical use namely epoetin alfa and beta, had a short half-life and needed to be administered twice or thrice a week [5]. ESAs are basically administered thrice a week to hemodialysis (HD) patients, anemia is the complication that has the greatest impact on perceived quality of life in HD patients. CERA has a longer half-life, approximately 134 hours, when administered intravenously to HD patients [10]. It is uncertain if switching HD patients from DA to CERA stabilizes their target Hb level. The aim of the present study was to assess the effects of switching from DA to CERA on the Hb level of a cohort of Japanese HD patients with renal anemia
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