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Morbidity Related to Secondary Hyperparathyroidism After Renal Transplantation (SHPT-RT)

2012年12月3日 更新者:Gunnar Sterner、Skane University Hospital

Secondary Hyperparathyroidism Related Vascular and Bone Morbidity After Renal Transplantation - a 6 Year Follow up Retrospective Cohort Study.

The purpose of the study is to evaluate the long term vascular morbidity and mortality in kidney transplant recipients based on one year post transplant levels of intact parathyroid hormone.

研究概览

详细说明

Secondary hyperparathyroidism (SHPT) is a well known complication to chronic renal failure. With impaired renal function the phosphate excretion from the kidney is reduced. Together with low levels of 25- and 1,25-vitamin D3 and hypocalcemia this uremic mineral milieu drives the release of parathyroid hormone (PTH) and the development of SHPT. PTH has many functions but acts mainly to release calcium from the skeleton, to enhance calcium uptake from the intestines (by actions on vitamin D) and to lower serum phosphate by inducing phosphaturia. SHPT has been shown to cause vascular morbidity and fractures in the chronic kidney disease (CKD) patient. After successful renal transplantation (RT) the mineral disturbances are mostly recovered and stabilized at one year post RT, but in recent years it has been shown that SHPT persists in the major part of RT-recipients even after long term follow up. This has been associated with high risk of fractures and vascular related morbidity in the post transplant period. It has also been shown that low levels of iPTH in the post-transplant period might be associated with a high risk of fractures. Because of insufficient data on PTH levels and associated morbidity there is no specific recommendations of target PTH levels in the RT-patient. This indicates that there is need for further observational studies to describe the SHPT-associated morbidity in a post transplant cohort based on stabilized levels of post transplant iPTH.

研究类型

观察性的

注册 (实际的)

257

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 85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

All patients who underwent renal transplantation surgery between January 1:st 2003 to December 31:st 2005 at Skane University Hospital or Karolinska University Hospital.

描述

Inclusion Criteria:

  • Between 18-85 years at date of transplantation
  • Signed informed consent or deceased at time of data collection

Exclusion Criteria:

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

队列和干预

团体/队列
PTH below target iPTH in CKD
iPTH at one year post transplantation below target range of iPTH by stage of CKD (KDOQI-guidelines).
iPTH within target range of iPTH in CKD
iPTH at one year post transplantation within target range of iPTH by stage of CKD (KDOQI-guidelines).
iPTH above target range of iPTH in CKD
iPTH at one year post transplantation above target range of iPTH by stage of CKD (KDOQI-guidelines).

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
First Vascular Event
大体时间:From date of transplantation to event up to 72 months
Vascular events defined as (Myocardial infarction, Stroke, Peripheral Vascular Occlusion)
From date of transplantation to event up to 72 months

次要结果测量

结果测量
措施说明
大体时间
Loss of Graft Function
大体时间:From date of transplantation to event up to 72 months
Start in Active Uremic Treatment (dialysis, renal transplantation)
From date of transplantation to event up to 72 months
Overall Mortality
大体时间:Fram date of transplantation to event up to 72 months
Mortality
Fram date of transplantation to event up to 72 months

其他结果措施

结果测量
措施说明
大体时间
First Fracture
大体时间:From date of transplantation to event up to 72 months
Fracture verified by x-ray
From date of transplantation to event up to 72 months

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。

调查人员

  • 研究主任:Gunnar Sterner, MD A/Prof、Dept of Nephrology and Transplantation Skane University Hospital Malmo
  • 学习椅:Astrid Seeberger, PhD, A/Prof、´Dept of nephrology, Karolinska University Hospital Huddinge, Stockholm
  • 学习椅:Elin Isaksson, MD、Dept of Nephrology and Transplantation Skane University Hosptial Malmö

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。

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2月1日

初级完成 (实际的)

2012年10月1日

研究完成 (实际的)

2012年10月1日

研究注册日期

首次提交

2012年11月30日

首先提交符合 QC 标准的

2012年12月3日

首次发布 (估计)

2012年12月4日

研究记录更新

最后更新发布 (估计)

2012年12月4日

上次提交的符合 QC 标准的更新

2012年12月3日

最后验证

2012年11月1日

更多信息

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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