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An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia

2017年6月13日更新者：Hoffmann-La Roche

Efficacy of C.E.R.A. for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients on Dialysis , Treated According to Routine Clinical Practice

This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.

研究概览

地位

完全的

条件

贫血

研究类型

观察性的

注册 (实际的)

127

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

印度
- - Ahmedabad、印度、380005
    - Ahmedabad Dialysis Centre
  - Guwahati、印度、781007
    - Excel Center
  - Kolkata、印度、600054
    - ESIS Hospital; Department of Nephrology
  - Mumbai、印度、400083
    - Vertex Hospital
  - New Delhi、印度、110076
    - Apollo Indraprastha Hospitals; Nephrology
  - Pune、印度、411033
    - Aditya Birla Memorial Hospital
- Delhi
  - New Delhi、Delhi、印度、110060
    - Sir Gangaram Hospital

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年至 65年 (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

概率样本

研究人群

Patients with chronic kidney disease on dialysis receiving treatment with Mircera for chronic renal anemia

描述

Inclusion Criteria:

Adult patients, 18 to 65 years of age, inclusive
Patients with chronic kidney disease on dialysis
ESA naïve with Hb < 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
Adequate irons status as judged by the treating physician

Exclusion Criteria:

Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
Clinically significant concomitant disease or disorder as defined by protocol
Clinical suspicion of pure red cell aplasia (PRCA)
Planned elective surgery during the study period , except for cataract surgery or vascular access surgery
Transfusion of red blood cells in the previous 2 months
Pregnant women
Contraindications for Mircera according to local prescribing information or as judged by the investigator

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
队列

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
Mean Age of Participants Treated With C.E.R.A 大体时间：Baseline (Week 0)	Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25	Baseline (Week 0)
Mean Weight of Participants Treated With C.E.R.A 大体时间：Baseline (Week 0)	Weight of the participants was measured at the Baseline and summarized with descriptive statistics.	Baseline (Week 0)
Number of Participants With Co-morbidity Treated With C.E.R.A 大体时间：Up to Week 24	Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.	Up to Week 24
Mean Time Required to Achieve Target Hemoglobin Range 大体时间：Up to Week 24	The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1	Up to Week 24
Percentage of Participants Achieved Target Range of Hemoglobin 大体时间：Up to Week 24	The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1. The percentage of participants with Hb < 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.	Up to Week 24
Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants. 大体时间：Up to Week 24	Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.	Up to Week 24

次要结果测量

结果测量	措施说明	大体时间
Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study 大体时间：Up to Week 24	For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.	Up to Week 24
Mean Time Spent by Participants in the Hb Target Range 大体时间：Up to Week 24	Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range. The target Hb range in the study was 10-12 g/dL.	Up to Week 24
Evaluation of Route of Administration for C.E.R.A 大体时间：Up to Week 24	C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration. The frequency (number of injections) for both of these routes of administration used in the study was reported.	Up to Week 24
Evaluation of Dose Per Injection of C.E.R.A 大体时间：Up to Week 24	The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information. Mean dose per injection of C.E.R.A received by participants was reported.	Up to Week 24
Number of Participants Received Concomitant Medications 大体时间：Up to Week 24	Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications. The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine. Participants treated with the each of these concomitant medications were reported.	Up to Week 24

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

Hoffmann-La Roche

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 (实际的)

2011年4月30日

初级完成 (实际的)

2013年9月30日

研究完成 (实际的)

2013年9月30日

研究注册日期

首次提交

2012年8月30日

首先提交符合 QC 标准的