此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

TRANSFORM - Observational Cohort Study of Darbepoetin Alfa Use in European Union (EU) Hemodialysis Patients Switched From PEG Epoetin Beta (TRANSFORM)

2014年6月3日更新者：Amgen

TRANSFORM - Observational Cohort Study of Aranesp Use in EU Haemodialysis Patients Switched From Mircera

To describe the time course of hemoglobin concentration in EU hemodialysis patients switched from methoxy polyethylene glycol-epoetin beta (PEG epoetin beta; Mircera) to darbepoetin alfa (Aranesp).

研究概览

地位

完全的

条件

贫血

详细说明

This is a multi-centre, observational cohort study of EU hemodialysis patients whose erythropoiesis stimulating agent (ESA) therapy has been switched from PEG epoetin beta to darbepoetin alfa. Data will be collected for the period spanning 14 weeks prior to switch through to 26 weeks post-switch.

研究类型

观察性的

注册 (实际的)

1027

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

希腊
- - Athens、希腊、11528
    - Research Site
  - Athens、希腊、15562
    - Research Site
德国
- - Kiel、德国、24106
    - Research Site
  - Nordhorn、德国、48527
    - Research Site
比利时
- - Edegem、比利时、2650
    - Research Site
法国
- - Antony、法国、92160
    - Research Site
  - Aurillac、法国、15000
    - Research Site
  - Blois、法国、41000
    - Research Site
  - Boulogne sur Mer、法国、62200
    - Research Site
  - Béziers、法国、34500
    - Research Site
  - Cahors、法国、46000
    - Research Site
  - Essey lès Nancy、法国、54270
    - Research Site
  - Grabels、法国、34790
    - Research Site
  - La Roche sur Yon Cedex 9、法国、85925
    - Research Site
  - La Réunion、法国、97420
    - Research Site
  - Libourne、法国、33505
    - Research Site
  - Lille Cedex、法国、59800
    - Research Site
  - Metz、法国、57000
    - Research Site
  - Paris、法国、75015
    - Research Site
  - Paris、法国、75016
    - Research Site
  - Poitiers、法国、86021
    - Research Site
  - Saint Nazaire、法国、44606
    - Research Site
  - Saint Pierre、法国、97410
    - Research Site
  - Saint Priest en Jarez、法国、42270
    - Research Site
  - Saint-Denis de la Réunion、法国、97400
    - Research Site
  - Strasbourg、法国、67000
    - Research Site
  - Vandoeuvre Les Nancy Cedex、法国、54504
    - Research Site
瑞士
- - Sion、瑞士、1950
    - Research Site
荷兰
- - Arnhem、荷兰、6815 AD
    - Research Site
西班牙
- Galicia
  - Ribeira、Galicia、西班牙、15993
    - Research Site
  - Santiago de Compostela、Galicia、西班牙、15706
    - Research Site
  - Santiago de Compostela、Galicia、西班牙、15701
    - Research Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

CKD dialysed patients from EU centers treated with PEG epoetin beta for a minimum of 14weeks prior to switching to darbepoetin alfa.

描述

Inclusion Criteria:

Patients >18 years of age. CKD diagnosis, receiving hemodialysis
Received PEG epoetin beta for 14weeks prior to switching to darbepoetin alfa and received at least one dose of darbepoetin alfa.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Chronic Kidney Disease (CKD) Participants with CKD on dialysis and treated with PEG epoetin beta for a minimum of 14 weeks immediately prior to being switched to darbepoetin alfa.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Hemoglobin Concentration at Monthly Intervals 大体时间：Month -3, -2, -1 (pre-switch), and Month 1, 2, 3, 4, 5 and 6 (post-switch)	Hemoglobin concentration from 3 months prior to switch to darbepoetin alfa until the end of the observation period.	Month -3, -2, -1 (pre-switch), and Month 1, 2, 3, 4, 5 and 6 (post-switch)

次要结果测量

结果测量	措施说明	大体时间
PEG Epoetin Beta Dose From the Start of the Observation Period Until the Switch 大体时间：Month -3, Month -2, Month -1	Mean weekly doses were calculated per participant by first calculating a mean daily dose for the interval (by dividing each dose evenly between the days bounded by its date of administration and the day before the next dose, then taking a mean of these partial doses for the days in the interval) and multiplying by 7 to convert to a weekly dose. Weekly doses >150 μg have been excluded as they were deemed infeasible values derived by the algorithm.	Month -3, Month -2, Month -1
Darbepoetin Alfa Dose From the Switch Date Until the End of the Observation Period 大体时间：Month 1, 2, 3, 4, 5 and 6	Mean weekly doses were calculated per participant by first calculating a mean daily dose for the interval (by dividing each dose evenly between the days bounded by its date of administration and the day before the next dose, then taking a mean of these partial doses for the days in the interval) and multiplying by 7 to convert to a weekly dose. Weekly doses >150 μg have been excluded as they were deemed infeasible values derived by the algorithm.	Month 1, 2, 3, 4, 5 and 6
Dose Ratio Measured at the Time of Switch From PEG Epoetin Beta to Darbepoetin Alfa 大体时间：Week -1 and Week 1	Dose ratio is the average weekly dose of the first darbepoetin alfa dose divided by the average weekly dose of peg-epoetin beta at switch (μg darbepoetin alfa per 1 μg pegylated-epoetin beta).	Week -1 and Week 1
Hemoglobin Concentration Rate of Change by Period 大体时间：Thre months prior to switch and 6 months after the switch	The hemoglobin rate of change is the maximum monthly increase and maximum monthly decrease for the pre- and post-switch periods. Within each period, the difference was calculated between each hemoglobin value and the most recent hemoglobin value taken at least 28 days previously. The rate of change was calculated by dividing this difference by the number of days in the interval and multiplying by 28. The maximum and minimum rate of change was then determined per participant.	Thre months prior to switch and 6 months after the switch
Percentage of Participants With Hemoglobin Excursions 大体时间：Month -3, -2, -1, 1, 2, 3, 4, 5 and 6	The percentage of participants with at least one hemoglobin excursion, defined as hemoglobin concentrations below 10.0 g/dL and above 12.0 g/dL during the pre- and post-switch periods.	Month -3, -2, -1, 1, 2, 3, 4, 5 and 6

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Amgen

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Preservation of anemia control and weekly ESA dosage after conversion from PEG-Epoetin beta to darbepoetin alfa in adult hemodialysis patients: the TRANSFORM study. Adv Ther. 2014 Nov;31(11):1155-68. doi: 10.1007/s12325-014-0161-5. Epub 2014 Nov 1.

有用的网址

AmgenTrials clinical trials website

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年8月1日

初级完成 (实际的)

2013年6月1日

研究完成 (实际的)

2013年7月1日

研究注册日期

首次提交

2012年12月18日

首先提交符合 QC 标准的

2013年11月25日

首次发布 (估计)

2013年11月28日

研究记录更新

最后更新发布 (估计)

2014年6月9日

上次提交的符合 QC 标准的更新

2014年6月3日

最后验证

2014年6月1日