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首页> 外文期刊>Trials >Comparison of different dosing regimens (once weekly vs. twice weekly, and once weekly vs. once every two weeks) with epoetin delta in patients with chronic kidney disease: a randomized controlled trial
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Comparison of different dosing regimens (once weekly vs. twice weekly, and once weekly vs. once every two weeks) with epoetin delta in patients with chronic kidney disease: a randomized controlled trial

机译：慢性肾脏病患者不同剂量给药方案（每周一次，每周两次，每周两次，每两周一次）与依泊汀的比较：一项随机对照试验

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Background Anaemia is a common complication of chronic kidney disease and prevalence increases with declining renal function. Renal anaemia has significant implications for the well-being and quality of life of patients and impacts on morbidity and mortality. Anaemia can be well managed by therapy with erythropoiesis-stimulating agents (ESAs). Previous clinical trials have shown that the only human cell-line-derived ESA, epoetin delta, is well tolerated and effective in maintaining haemoglobin levels in anaemic patients with chronic kidney disease. The half-life of epoetin delta suggests that administration of this agent is feasible once weekly and once every two weeks. We report on the design and rationale of a trial to compare once weekly vs. twice weekly, and once weekly vs. once every two weeks dosing of epoetin delta. Design and methods This is a randomized, open-label, multicentre trial. Patients aged 18 years or above with chronic kidney disease (Stages 3–5) are eligible to enter this trial. Two groups of patients form the trial population, those na?ve to ESA therapy and those previously stable on ESA therapy. There are two primary objectives of this trial: 1) to demonstrate non-inferiority between twice weekly and once weekly dosing of epoetin delta in previously na?ve patients (assessed by haemoglobin at Week 24); 2) to demonstrate non-inferiority between once weekly and once every two weeks dosing in previously stable patients (assessed by average haemoglobin over Weeks 16–24). Among the secondary analyses will be assessments of haematocrit, number(%) of patients meeting predefined targets for haemoglobin and haematocrit levels, and comparisons of average dose. All patients will receive study medication for 24 weeks and dose will be adjusted according to a predefined algorithm to achieve and maintain haemoglobin ≥ 11 g/dL. All patients completing this trial are eligible to enter a 2-year follow-up study to enable monitoring of emergent adverse events, anti-erythropoietin antibody responses, maintenance of efficacy and changes in diabetic retinopathy status. Discussion To our knowledge, this trial is the first to randomize ESA-na?ve patients to different dosing regimens of the same ESA. Data generated will help in guiding the most appropriate dosing frequency for epoetin delta, particularly in those patients new to epoetin delta therapy. Trial registration ClinicalTrials.gov: NCT00450333
机译：背景贫血是慢性肾脏疾病的常见并发症，患病率随肾功能下降而增加。肾性贫血对患者的健康和生活质量有重大影响，并影响发病率和死亡率。贫血可以通过红细胞生成刺激剂（ESA）进行治疗。先前的临床试验表明，唯一的人类细胞源性ESA依泊汀（epoetin delta）具有良好的耐受性，并能有效维持慢性肾病贫血患者的血红蛋白水平。依泊汀δ的半衰期表明，每周一次和每两周一次给药是可行的。我们报告了一项试验的设计和基本原理，以比较每周一次与每周两次，每周一次与每两周一次一次的依泊汀δ剂量比较。设计和方法这是一项随机，开放标签的多中心试验。 18岁或以上患有慢性肾脏病（第3-5期）的患者有资格参加该试验。两组患者组成了试验人群，即初次接受ESA治疗的患者和以前接受ESA治疗的患者。该试验的两个主要目的是：1）证明既往天真的患者在每周两次和每周一次的依泊汀增量给药之间无劣势（在第24周时通过血红蛋白评估）; 2）证明以前稳定的患者在每周一次和每两周一次给药之间无劣势（通过第16-24周的平均血红蛋白评估）。次要分析包括评估血细胞比容，达到血红蛋白和血细胞比容水平预定目标的患者人数（％），以及平均剂量的比较。所有患者将接受为期24周的研究药物，并且将根据预定义的算法调整剂量，以达到并维持血红蛋白≥11 g / dL。所有完成该试验的患者都有资格进入为期2年的随访研究，以监测紧急不良事件，抗促红细胞生成素抗体反应，疗效维持和糖尿病性视网膜病变状态的改变。讨论据我们所知，该试验是第一个将未使用过ESA的患者随机分配到同一ESA的不同给药方案的试验。产生的数据将有助于指导最合适的依泊汀三角洲给药频率，特别是对于那些依泊汀三角洲治疗新手的患者。试用注册ClinicalTrials.gov：NCT00450333

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