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Study to Evaluate the Effect of Intravenous (IV) Paricalcitol (Zemplar) on Cardiac Morbidity in Patients With Chronic Kidney Disease (CKD) Stage 5 Over 2 Years

2014年6月9日更新者：AbbVie (prior sponsor, Abbott)

Postmarketing Observational Study to Evaluate the Effect of Zemplar (Paricalcitol IV) on Cardiac Morbidity in Patients With Chronic Kidney Disease Stage 5 Over 2 Years.

The purpose of this study was to ascertain the percentage of cardiac patients with chronic kidney disease (CKD) stage 5 treated with paricalcitol IV achieving intact parathyroid hormone (iPTH) levels in target range of Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines (150 - 300 pg/mL) after 2 years.

研究概览

地位

完全的

条件

详细说明

Secondary hyperparathyroidism (SHPT) is a frequent complication in patients with chronic kidney disease (CKD) stage 5 receiving dialysis. SHPT is an adaptive response to CKD and is characterized by an elevation in parathyroid hormone (PTH) and consecutively high calcium levels. Elevations in calcium levels, phosphate levels, and PTH are correlated with CKD disease progression as well as development or aggravation of cardiovascular impairment. Many CKD patients cannot be treated well with Vitamin D analogues because of effects on calcium. Hypercalcemia is a well - known factor for cardiac disease. No data are available in Austria for a cohort with cardiac disease treated with Zemplar (paricalcitol IV).

研究类型

观察性的

注册 (实际的)

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

奥地利
- - Graz、奥地利、8010
    - Site Reference ID/Investigator# 27447
  - Graz、奥地利、8020
    - Site Reference ID/Investigator# 49182
  - Graz、奥地利、80360
    - Site Reference ID/Investigator# 27483
  - Graz、奥地利、8052
    - Site Reference ID/Investigator# 52742
  - Innsbruck、奥地利、6020
    - Site Reference ID/Investigator# 27487
  - Linz、奥地利、4010
    - Site Reference ID/Investigator# 36983
  - Linz、奥地利、4020
    - Site Reference ID/Investigator# 27484
  - Rottenmann、奥地利、8786
    - Site Reference ID/Investigator# 27485
  - Vienna、奥地利、1030
    - Site Reference ID/Investigator# 27446
  - Vienna、奥地利、1090
    - Site Reference ID/Investigator# 53469
  - Vienna、奥地利、1130
    - Site Reference ID/Investigator# 27482
  - Vienna、奥地利、1220
    - Site Reference ID/Investigator# 10981

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

Investigational sites were clinic centers with experience in the treatment of chronic kidney disease stage 5 patients and hemodialysis.

描述

Inclusion Criteria:

Patients aged at least 18 years
Patients with secondary hyperparathyroidism associated with CKD stage 5, serum iPTH > 150 pg/mL,
Cardiac disease as described by Medical Dictionary for Regulatory Activities (MedDRA) terms:
- cardiac disorder as cardiac arrhythmias
- cardiac disorder signs and symptoms
- cardiac neoplasm
- cardiac valve disorder
- heart failures
- myocardial disorder
- pericardial disorder
- Serum phosphate level < 6.5 mg/dL and serum calcium level < 10.5 mg/dL

Exclusion Criteria:

Patients who meet contraindications as outlined in the latest version of Zemplar (Paricalcitol IV) summary of product characteristics
Patients with known hypersensitivity to paricalcitol or any component of the formulation, vitamin D intoxication, hypercalcemia; cinacalcet as concomitant medication.

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
Paricalcitol IV Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.

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
Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range 大体时间：Baseline and Months 3, 6, 12, 18, and 24	Target range of intact parathyroid hormone was defined according to the Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines as between 15.9 - 31.8 pmol/L (150 to 300 pg/mL).	Baseline and Months 3, 6, 12, 18, and 24

次要结果测量

结果测量	措施说明	大体时间
Percentage of Participants With Hypercalcemia 大体时间：Baseline and Months 3, 6, 12, 18, and 24	Hypercalcemia was defined as a calcium value of > 2.625 mmol/L (10.5 mg/dL) in one measurement. Serum calcium was measured at every study visit.	Baseline and Months 3, 6, 12, 18, and 24
Percentage of Participants With Hyperphosphatemia 大体时间：Baseline and Months 3, 6, 12, 18, and 24	Hyperphosphatemia was defined as a phosphate value of > 2.1 mmol/L (6.5 mg/dL) in one measurement. Serum phosphate was measured at every study visit.	Baseline and Months 3, 6, 12, 18, and 24
Percentage of Participants With at Least a 30%-Reduction in iPTH Levels 大体时间：Baseline and Months 3, 6, 12, 18, and 24	The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) levels from Baseline level.	Baseline and Months 3, 6, 12, 18, and 24
Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements 大体时间：Baseline to Month 24	The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) level from Baseline in at least 2 consecutive visits.	Baseline to Month 24
Percentage of Participants With at Least One Concomitant Medication 大体时间：24 months	The percentage of participants with at least one concomitant medication during the course of the study, by the following types: Phosphate binder Epoetin Renin-Angiotensin-Aldosterone System (RAAS) inhibitors Cinacalcet Other	24 months
Percentage of Participants Experiencing Hospitalization 大体时间：24 months	The percentage of participants with at least one hospitalization, at least one cardiac-related hospitalization and at least one non-cardiac-related hospitalization during the course of the study.	24 months
Number of Participants With Cardiac Disease Progression 大体时间：Month 3, 6, 12, 18, and 24	Cardiac disease progression was determined by the Investigator.	Month 3, 6, 12, 18, and 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

AbbVie (prior sponsor, Abbott)

合作者

Assign Data Management and Biostatistics GmbH

调查人员

研究主任：Astrid Dworan-Timler、AbbVie Austria

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。

有用的网址

Related Info

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

2008年12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6月1日

研究注册日期

首次提交

2010年2月20日

首先提交符合 QC 标准的

2010年2月22日

首次发布 (估计)

2010年2月23日

研究记录更新

最后更新发布 (估计)

2014年7月10日

上次提交的符合 QC 标准的更新

2014年6月9日

最后验证

2014年6月1日

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