Department of Renal Diseases, Division of Internal Medicine, Oji Hospital, 2-14-13 Oji, Kita-ku, Tokyo 114-0002, Japan.
Clin Exp Nephrol. 2011 Dec;15(6):884-92. doi: 10.1007/s10157-011-0527-9. Epub 2011 Sep 7.
Darbepoetin alfa (KRN321) is a recombinant protein that stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Due to its longer half-life and greater biological activity than recombinant human erythropoietin (rHuEPO), KRN321 maintains an effective hemoglobin (Hb) level at extended dose intervals compared with rHuEPO. The efficacy and safety of KRN321 administered subcutaneously to patients on peritoneal dialysis (PD) were tested.
In a multicenter, open-label, single-arm study, KRN321 was administered subcutaneously to patients on PD for 26-28 weeks. Ninety-six patients initially were given a 60 μg subcutaneous dose once every 2 weeks until a target of Hb (11.0-13.0 g/dL) was achieved. Thereafter, their dose was every 2 or 4 weeks.
After the target of Hb was reached in most subjects (96.9%), it was maintained with KRN321 administered every 2 or 4 weeks. On completion of (or withdrawal from) study, 65 subjects (67.7%) maintained the target Hb. Although a number of adverse event related to hypertension occurred, their incidence did not appear to be related to Hb or its rate of increase. These events could be controlled adequately by interrupting or reducing the dose, and/or treatment with antihypertensives.
The efficacy and safety of KRN321 when administered subcutaneously for 28 weeks to PD patients were confirmed. It was suggested that the quality of life of patients can be improved by treatment with KRN321 due to the reduced frequency of administration.
达贝泊汀α（KRN321）是一种重组蛋白，通过与内源性促红细胞生成素相同的机制刺激红细胞生成。由于其半衰期长于重组人促红细胞生成素（rHuEPO），并且生物活性更强，与 rHuEPO 相比，KRN321 可在延长的给药间隔内维持有效的血红蛋白（Hb）水平。本研究旨在检验 KRN321 皮下给药治疗腹膜透析（PD）患者的疗效和安全性。
在一项多中心、开放标签、单臂研究中，96 例 PD 患者接受 KRN321 皮下治疗，疗程 26-28 周。最初，所有患者均接受 60 μg 皮下剂量，每 2 周给药 1 次，直至达到 Hb（11.0-13.0 g/dL）目标值。此后，其剂量可每 2 或 4 周给药 1 次。
大多数患者（96.9%）达到 Hb 目标值后，用 KRN321 维持治疗，每 2 或 4 周给药 1 次。完成（或退出）研究时，65 例（67.7%）患者维持了目标 Hb 值。尽管有一些与高血压相关的不良事件发生，但它们的发生率似乎与 Hb 或 Hb 增加速度无关。这些事件可通过中断或减少剂量，以及/或使用抗高血压药物来充分控制。
KRN321 皮下治疗 28 周对 PD 患者的疗效和安全性得到了证实。由于给药频率降低，用 KRN321 治疗可改善患者的生活质量。
