Abstract:
BACKGROUND:Darbepoetin alfa (DA) is an attractive alternative to recombinant human erythropoietin (rHuEPO) in managing renal anemia. Since DA has not been approved by the appropriate Japanese drug regulatory agencies for the indication of renal anemia in children in Japan, we have conducted a multicenter prospective study to determine the efficacy and safety of DA in Japanese children undergoing peritoneal dialysis (PD). METHODS:Pediatric patients subcutaneously receiving rHuEPO were switched to DA treatment for a period of 28 weeks. The conversion to the initial dose of DA was calculated as 1 μg DA for 200 IU rHuEPO, and DA was administered intravenously once every 2 weeks. The target hemoglobin (Hb) concentration was defined as 11.0 to ≤13.0 g/dL. In some patients, the dose of DA was adjusted appropriately to achieve this target level, and/or the dosing frequency changed to once every 4 weeks. RESULTS:In the 25 patients switched from rHuEPO to DA the mean Hb concentration increased from 9.9 ± 1.0 to 11.1 ± 1.0 g/dL at 8 weeks following commencement of the DA treatment. The target Hb concentration was achieved in 88 % of these patients, and 60 % maintained this target value on completion of the study. The dosing frequency was extended to once every 4 weeks in 60 % of patients. Twenty-four adverse events were noted in 11 of 25 patients (44 %); however, there was no causality between DA and adverse events. CONCLUSIONS:The results of this study suggest that intravenous administration of DA once every 2 or 4 weeks is an effective and safe treatment for renal anemia in Japanese children undergoing PD.
journal_name
Clin Exp Nephroljournal_title
Clinical and experimental nephrologyauthors
Hattori M,Matsunaga A,Akioka Y,Fujinaga S,Nagai T,Uemura O,Nakakura H,Ashida A,Kamei K,Ito S,Yamada T,Goto Y,Ohta T,Hisano M,Komatsu Y,Itami Ndoi
10.1007/s10157-012-0714-3subject
Has Abstractpub_date
2013-08-01 00:00:00pages
582-8issue
4eissn
1342-1751issn
1437-7799journal_volume
17pub_type
临床试验,杂志文章,多中心研究abstract::Heavy chain deposition disease (HCDD) is one of three entities of monoclonal immunoglobulin deposition disease, characterized histopathologically by the presence of nodular glomerulosclerosis and glomerular and tubular deposition of monoclonal heavy chains without associated light chains. Although HCDD is an extremely...
journal_title:Clinical and experimental nephrology
pub_type: 杂志文章,评审
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pub_type: 临床试验,杂志文章,多中心研究
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