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Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease

2011年12月20日 更新者：Abbott

A Phase 3b, Randomized, Active-Controlled, Single-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Paricalcitol Injection in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects Receiving Hemodialysis

Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease

研究概览

地位

完全的

条件

干预/治疗

详细说明

Evaluate the safety and efficacy of paricalcitol injection with two different dosing regimens (currently approved dosing regimen used in the US package insert versus dosing based on a formula of iPTH/80 that was approved and used in the EU package insert) in Chronic Kidney Disease (CKD) Stage 5 subjects with secondary hyperparathyroidism receiving hemodialysis.

研究类型

介入性

注册 (实际的)

216

阶段

  • 第三阶段

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

  • 中国
      • Beijing、中国、100034
        • Site Reference ID/Investigator# 23483
      • Beijing、中国、100044
        • Site Reference ID/Investigator# 23485
      • Beijing、中国、100730
        • Site Reference ID/Investigator# 23482
      • Dalian City、中国、116011
        • Site Reference ID/Investigator# 23484
      • Guangzhou City、中国、510080
        • Site Reference ID/Investigator# 23486
      • Nanjing、中国、210029
        • Site Reference ID/Investigator# 23488
      • Qingdao、中国、266003
        • Site Reference ID/Investigator# 37722
      • Shanghai、中国、200001
        • Site Reference ID/Investigator# 23490
      • Shanghai、中国、200001
        • Site Reference ID/Investigator# 25502
      • Shanghai、中国、200025
        • Site Reference ID/Investigator# 23489
      • Shanghai、中国、200092
        • Site Reference ID/Investigator# 23487
      • Wenzhou、中国、325000
        • Site Reference ID/Investigator# 35822

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

20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

描述

Inclusion Criteria:

  1. Subject is a Chinese male or female greater than or equal to 20 years old.
  2. Subject is diagnosed with Chronic Kidney Disease Stage 5 and must be on maintenance hemodialysis three times a week for at least 2 months prior to the Screening Visit and expected to remain on hemodialysis for the duration of the study.

  3. For entry into the Treatment Phase, the subject must have:

    • Intact parathyroid hormone greater than or equal to 300 pg/mL
    • Serum calcium less than 10.2 mg/dL (2.55 mmol/L)
    • Calcium-phosphorus product less than 65 mg^2/dL^2

Exclusion Criteria:

  1. Subject has a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.
  2. Subject received a partial parathyroidectomy within one year prior to the Screening Phase.
  3. Subject with New York Heart Association (NYHA) Class III or IV.
  4. Subject has taken aluminum-containing phosphate binders for greater than 3 weeks in the last 3 months prior to the Screening Phase, or requires such medications for greater than 3 weeks in the study.
  5. Subject has a current malignancy (with the exception of basal or squamous cell carcinoma of the skin), or clinically significant liver disease, in the opinion of the Investigator.
  6. Subject has a history of drug or alcohol abuse within 6 months prior to the Screening Phase.
  7. Subject is known to be human immunodeficiency virus (HIV) positive.
  8. Subject has evidence of poor compliance with diet, medication or hemodialysis that may interfere, in the Investigator's opinion, with adherence to the protocol.

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

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：单组作业
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Group 1
Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
药品：paricalcitol
Initiation dosing based on 2 approved package inserts , followed by a dose adjusted by limited chemistry test value. See Arm Description for additional details.
其他名称：
  • 赞普乐
  • ABT-358
有源比较器：Group 2
Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
药品：paricalcitol
Initiation dosing based on 2 approved package inserts , followed by a dose adjusted by limited chemistry test value. See Arm Description for additional details.
其他名称：
  • 赞普乐
  • ABT-358

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
The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels
大体时间：Baseline to 12 Weeks
The number of participants who achieved (Yes) or did not achieve (No) two consecutive decreases of greater than or equal to 30% from baseline in intact parathyroid hormone (iPTH) values
Baseline to 12 Weeks

次要结果测量

结果测量
措施说明
大体时间
The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL
大体时间：Baseline to 12 Weeks
The number of subjects with (Yes) or without (No) final intact parathyroid hormone (iPTH) values between 150 and 300 pg/mL
Baseline to 12 Weeks
The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value
大体时间：Baseline to 12 Weeks
Baseline to 12 Weeks
The Change From Baseline to the Final Observation in Calcium
大体时间：Baseline to 12 Weeks
Baseline to 12 Weeks
The Change From Baseline to the Final Observation in Calcium-phosphorus Product
大体时间：Baseline to 12 Weeks
Baseline to 12 Weeks
The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure
大体时间：Baseline to 12 Weeks
Baseline to 12 Weeks
The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure
大体时间：Baseline to 12 Weeks
Baseline to 12 Weeks
The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate
大体时间：Baseline to 12 Weeks
Baseline to 12 Weeks
The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L)
大体时间：Baseline to 12 weeks
The number of subjects with (Yes) or without (No) two consecutive calcium measurements greater than 11.0 mg/dL (2.75 mmol/L)
Baseline to 12 weeks

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

  • 研究主任：Yue Kang, MD、Abbott (China)

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

2009年11月1日

初级完成 (实际的)

2010年11月1日

研究完成 (实际的)

2010年11月1日

研究注册日期

首次提交

2009年11月25日

首先提交符合 QC 标准的

2010年2月17日

首次发布 (估计)

2010年2月19日

研究记录更新

最后更新发布 (估计)

2012年1月26日

上次提交的符合 QC 标准的更新

2011年12月20日

最后验证

2011年12月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • M06-823

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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