Safety and efficacy of monthly administration of darbepoetin alfa compared to the methoxy polyethylene glycol-epoetin beta in the treatment of anemia associated with chronic kidney disease in non-dialysis patients

开始日期2018-09-03

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100 项与阿法达贝泊汀生物类似药(Mylan EPD LLC) 相关的专利（医药）

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项与阿法达贝泊汀生物类似药(Mylan EPD LLC) 相关的文献（医药）

2011-12-01·Clinical and Experimental Nephrology3区 · 医学

Darbepoetin alfa (KRN321) is safe and effective when administered subcutaneously once every 2 or 4 weeks to patients on peritoneal dialysis in Japan

3区 · 医学

Article

作者: Manabu Iwasaki ; Makoto Hiramatsu ; Minoru Kubota ; Satoshi Morita ; Tadao Akizawa ; Masato Yamakawa ; Shunichi Fukuhara

BACKGROUNDDarbepoetin 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.METHODSIn 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.RESULTSAfter 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.CONCLUSIONSThe 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.

2008-02-01·Therapeutic Apheresis and Dialysis4区 · 医学

Darbepoetin Alfa (KRN321) Administered Intravenously Once Monthly Maintains Hemoglobin Levels in Peritoneal Dialysis Patients

4区 · 医学

Article

作者: Shozo Koshikawa ; Manabu Iwasaki ; Makoto Hiramatsu ; Minoru Kubota ; Tadao Akizawa

Abstract: Darbepoetin alfa (KRN321) is a novel molecule 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. This multicenter, open‐label, single‐arm study of 72 patients with end stage renal failure on peritoneal dialysis (PD) evaluated the efficacy and safety of KRN321 administered intravenously with the dosing intervals extended to monthly. PD patients that were either rHuEPO‐naïve or rHuEPO‐receiving were enrolled. In rHuEPO‐naïve patients, the initial dose of KRN321 was 40 μg weekly by intravenous administration. For rHuEPO‐receiving patients, an initial regimen of fortnightly intravenous administration was given and the initial dose was based on the dose of rHuEPO used before switching to KRN321. After starting the study medication, the Hb concentration was maintained between 10.0 g/dL and 13.0 g/dL. In those patients whose Hb concentrations showed a stable time‐course, the dosing intervals of KRN321 were extended. The results suggest that it may be feasible to reduce the frequency of treatment to a monthly schedule, with an associated adjustment of dose, in most patients. Adverse events were observed in 67 of the 72 patients (93.1%, 267 events). Most of all the adverse events were reported in patients with chronic renal failure receiving conventional rHuEPO. No safety problems specific to KRN321 were noted. These results suggest that KRN321 could reduce of frequency of hospital visits for PD patients receiving erythropoietic therapy for renal anemia.

2007-06-01·Therapeutic Apheresis and Dialysis4区 · 医学

Darbepoetin Alfa Effectively Maintains Hemoglobin Concentrations at Extended Dose Intervals Relative to Intravenous rHuEPO in Japanese Dialysis Patients

4区 · 医学

Article

作者: Manabu Iwasaki ; Tadao Akizawa ; Shozo Koshikawa

Abstract: Darbepoetin alfa (KRN321) is a novel molecule that stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Due to its three‐fold 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. In this multicenter, open‐label study, 513 dialysis patients maintained on stable rHuEPO therapy were switched to KRN321 at extended dose intervals. Those receiving rHuEPO two (n = 144, 28.1%) or three times (n = 305, 59.5%) per week were switched to KRN321 once per week, and those receiving rHuEPO once per week (n = 64, 12.5%) were switched to KRN321 once every two weeks. The doses of KRN321 (10–120 μg) were titrated to maintain Hb concentrations at 10–13 g/dL and, if possible, within 11–12 g/dL for up to 52 weeks. If the Hb concentration remained between 10.5 and 12 g/dL, conversion of the dosing frequency from once per week to once every two weeks was allowed. Hemoglobin concentrations were maintained regardless of the dosing interval. The percentage of patients with Hb values within 11–12 g/dL was 23.6% at week 0, 41.3% at week 7, 46.1%−51.9% between weeks 11 and 22 and 45.6% at week 52. KRN321 was well tolerated and the safety profile was consistent with previous trials conducted for KRN321. KRN321, when administered at extended dose intervals, is well tolerated and effective Hb concentrations are attained in Japanese hemodialysis patients.

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