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Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism

2012年3月26日更新者：Abbott

A Two-year, Post-marketing Observational Study to Follow-up Patients With End Stage Renal Disease Undergoing Haemodialysis, Receiving Zemplar for Prevention and Treatment of Secondary Hyperparathyroidism

The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in Greece.

研究概览

地位

完全的

条件

详细说明

The primary objective of this study is to evaluate the safety of Zemplar® in the treatment of Secondary hyperparathyroidism (iParathormone>300 pg/mL) in subjects on hemodialysis treated in conditions of usual clinical care.

The primary safety endpoints of this study are to evaluate the safety of Zemplar by recording the number of hospitalizations and days hospitalized.

A secondary efficacy endpoint will be the proportion of subjects achieving therapeutic success. Therapeutic success with Zemplar® will be defined as:

40% reduction in the base iPTH level is achieved, and/or;
serum iParathormone level < 300 pg/mL.

Additional secondary endpoints are the incidence (proportion of patients) of clinically meaningful hypercalcemia (defined as corrected serum calcium (Ca) > 11.0 mg/dL taken at 2 consecutive measurements), hyperphosphatemia (defined as serum phosphorous (P)>6.5 mg/dL taken at 2 consecutive measurements), and elevated Ca x P product (defined as serum Ca x P>65 mg^2/dL^2 taken at 2 consecutive measurements). Safety also will be assessed through adverse event monitoring and evaluation of laboratory variables and vital signs.

研究类型

观察性的

注册 (实际的)

237

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、11526
    - Site Reference ID/Investigator# 32055
  - Athens、希腊、11528
    - Site Reference ID/Investigator# 32050
  - Athens、希腊、11528
    - Site Reference ID/Investigator# 32051
  - Athens、希腊、17237
    - Site Reference ID/Investigator# 32049
  - Athens、希腊
    - Site Reference ID/Investigator# 5283
  - Chalkida、希腊、34100
    - Site Reference ID/Investigator# 32056
  - Chania、希腊、73100
    - Site Reference ID/Investigator# 32057
  - Drama、希腊、66100
    - Site Reference ID/Investigator# 32058
  - Holargos、希腊、15562
    - Site Reference ID/Investigator# 32077
  - Katerini、希腊、60100
    - Site Reference ID/Investigator# 32076
  - Kavala、希腊、65201
    - Site Reference ID/Investigator# 32059
  - Komotini、希腊、69100
    - Site Reference ID/Investigator# 32053
  - Lamia、希腊、35100
    - Site Reference ID/Investigator# 32060
  - Lefkada、希腊、31100
    - Site Reference ID/Investigator# 32061
  - Livadia、希腊、32100
    - Site Reference ID/Investigator# 32062
  - Pireus、希腊
    - Site Reference ID/Investigator# 32048
  - Preveza、希腊、48100
    - Site Reference ID/Investigator# 32054
  - Ptolemaida、希腊、50200
    - Site Reference ID/Investigator# 32063
  - Volos、希腊、38222
    - Site Reference ID/Investigator# 32075

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

Hemodialysis patients with secondary hyperparathyoidism treated with IV Paricalcitol according to the approved Summary of Product Characteristics

描述

Inclusion Criteria:

Subject is >= 18 years of age and diagnosed with secondary hyperparathyroidism and a pretreatment iParathormone > 300 pg/mL.
Subject is receiving chronic hemodialysis.
Subject for which treatment with Zemplar Injection is indicated clinically according to the criteria of participating investigator.
Subject has provided their informed consent to participate.

Exclusion Criteria:

Subject has a corrected serum calcium > 10.5 mg/dL, serum phosphorus >= 6.5 mg/dL or subjects with corrected Ca x P >= 65 mg^2/dl^2.
Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients.
Subject has participated in clinical study within the last month.
Zemplar is contraindicated according to the Summary of Product Characteristics.

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 All eligible patients treated with IV Paricalcitol (Zemplar)

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
Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations 大体时间：Baseline to Month 24 Visit	The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.	Baseline to Month 24 Visit
Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized 大体时间：Baseline to Month 24 Visit	The mean (average) number of days hospitalized per participant for those hospitalized during the study.	Baseline to Month 24 Visit

次要结果测量

结果测量	措施说明	大体时间
The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml) 大体时间：Baseline to Month 24 Visit	Therapeutic success of paricalcitol treatment was defined as a 40% decrease from the baseline measurement in the level of intact parathyroid hormone (also known as iPTH or parathormone) and/or a serum intact parathyroid hormone level less than 300 picograms per milliliter (pg/mL) for at least 2 consecutive available measurements during the 24-month follow-up period.	Baseline to Month 24 Visit
The Incidence of Clinically Significant Hypercalcemia 大体时间：Baseline to Month 24 Visit	The number of participants with clinically significant hypercalcemia (too much calcium in the blood), defined as a corrected serum calcium level greater than 11.0 milligrams per deciliter (mg/dL) at 2 consecutive measurements.	Baseline to Month 24 Visit
The Incidence of Clinically Significant Hyperphosphatemia 大体时间：Baseline to Month 24 Visit	The number of participants with clinically significant hyperphosphatemia (too much phosphorous in the blood), defined as serum phosphorous levels greater than 6.5 milligrams per deciliter (mg/dL) at 2 consecutive measurements.	Baseline to Month 24 Visit
The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product 大体时间：Baseline to Month 24 Visit	The number of participants with clinically significant levels of calcium-phosphorous product (Ca x P), defined as serum calcium-phosphorous product levels greater than 65 milligrams squared per deciliters squared (mg^2/dL^2) at 2 consecutive measurements.	Baseline to Month 24 Visit
To Estimate the Incidence of (S)AEs/(S)ADRs 大体时间：Baseline to Month 24 Visit	The number of adverse events, serious adverse events (including death), adverse drug reactions, and serious adverse drug reactions experienced by participants during the study are summarized. Adverse events include any events reported regardless of whether or not they were considered related to the study drug. Adverse drug reactions include events where a causal relationship between the drug and the occurence of the event is suspected. For additional details see the Reported Adverse Events section.	Baseline to Month 24 Visit

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

Abbott

调查人员

学习椅：Konstantinos Xynos, MD、Abbott Laboratories Hellas S.A.

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

2006年12月1日

初级完成 (实际的)

2011年2月1日

研究完成 (实际的)

2011年2月1日

研究注册日期

首次提交

2010年2月27日

首先提交符合 QC 标准的

2010年3月4日

首次发布 (估计)

2010年3月5日

研究记录更新

最后更新发布 (估计)

2012年3月27日

上次提交的符合 QC 标准的更新

2012年3月26日

最后验证

2012年3月1日

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