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Comparative Renal Function of Young (18-45 Years) and Ageing (55 Years and Above) Kidney Donors

2018年4月26日 更新者:Jane C. Tan、Stanford University

Preserving Renal Longevity in Living Kidney Donors

It is our purpose in this study to compare the kidney structure and function of older patients to that of young patients before and after removal of a single kidney for transplant donation and to examine the remaining kidney's ability to adapt and maintain function over time. More specifically, we aim to examine the effect of uninephrectomy on adaptive hyperfiltration in the remaining kidney. A secondary aim is to investigate whether subjects in the aging population undergo compensation to the same extent as younger subjects. We will also examine the compensatory rise in GFR (glomerular filtration rate) that follows uninephrectomy in both groups, and, again, compare the results in the aged versus young subjects. This will help in delineating the extent to which the aging population can be a potential source of living kidney donors for kidney transplantation.

It is also our purpose with this study to refine the tests to be used in the donor evaluation process so as to accurately identify ideal candidates for safe kidney donation.

研究概览

详细说明

Screening Procedures: Patients will be identified after acceptance by Stanford's kidney transplant team as appropriate candidates for living kidney donation prior to their surgery.

The following assessments will be performed over the course of 4 years for this protocol.

A. Informed Consent will be obtained.

B. A Cimetidine Blocked 24 hour urine collection will be obtained prior to surgery.

C. DETAILED KIDNEY FUNCTION STUDIES will be performed using iothalamate, and PAH at three different times:

  1. Prior to surgery for uninephrectomy (the night before to months before surgery)
  2. 6 months to 1 year post kidney donation.
  3. 4 years after kidney donation.

D. The Structure of the Kidney will also be assessed at three different times during this protocol:

  1. Cortical and whole kidney volumes will be determined using the clinical MRI or CT performed routinely for kidney donor evaluation.
  2. At the time of surgery, in the operating room: A single wedge biopsy of the kidney will be taken for morphometric and later genetic analysis. *NOTE: Genetic analysis is for the genetics of ageing not disease. In this procedure, a small wedge kidney biopsy is excised under direct visualization by the transplant surgeon after the kidney has been removed from the donor and before the kidney is transplanted into the recipient. The area of excision is then oversewn and checked for bleeding.

    The size (volume) of the Tx kidney will be measured by water displacement in a graduated cylinder immediately before Tx. This volume will be used in our calculations to estimate the number of glomeruli in youthful vs ageing kidneys.

  3. A second MRI or CT will be obtained 6 months to 1 year after kidney donation to measure the kidney's overall compensatory growth and increase in cortical volume for comparison with the pre-operative volumes.

研究类型

观察性的

注册 (实际的)

120

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

    • California
      • Stanford、California、美国、94305
        • Stanford University School of Medicine

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

有资格学习的性别

全部

取样方法

非概率样本

研究人群

  1. Men and Women who are undergoing surgery for kidney donation for transplantation who are between the ages of 18 and 45, and 55 and above.
  2. Men and women who are undergoing surgery for kidney donation for transplantation who exhibit mild hypertension.
  3. Men and women who donated a kidney for transplantation 10 to 20 years ago.

描述

Inclusion Criteria:1. Patients who are over the age of 18. 2. Patients who are undergoing surgical uninephrectomy for the purpose of living donation for transplantation 3. Adults who had a single kidney removed for transplant donation 10-20 years ago.

4. All Patients enrolled in this study must be between the ages of 18 and 45 years or 55 years or older.

5. Patients undergoing surgery for kidney donation who exhibit mild hypertension controlled with one medication. Any age accepted Exclusion Criteria:1. Patients under the age of 18.

2. Patients between the ages of 46 and 54 3. Patients who are allergic to Inulin, Iothalamate, or PAH. 4. Women who are pregnant. 5. Other "Vulnerable Subjects"

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

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Diminished adaptive response to living kidney donation in ageing donors as compared to living donors.
大体时间:4 years
4 years

次要结果测量

结果测量
大体时间
Renal Failure & new onset, or worsening, of hypertension in living kidney donors
大体时间:4 yr
4 yr

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

  • 首席研究员:Bryan D Myers、Stanford University
  • 首席研究员:Jane C. Tan、Stanford University

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

2003年3月1日

初级完成 (实际的)

2012年12月1日

研究完成 (实际的)

2012年12月1日

研究注册日期

首次提交

2009年2月17日

首先提交符合 QC 标准的

2009年2月17日

首次发布 (估计)

2009年2月19日

研究记录更新

最后更新发布 (实际的)

2018年4月30日

上次提交的符合 QC 标准的更新

2018年4月26日

最后验证

2018年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • SU-02092009-1778
  • IRB eProtocol #13584
  • SPO 45339

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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