Long-Term Health Outcomes After Live Kidney Donation in African Americans

描述(申请人提供)：在美国，每年有超过6000名健康的人捐赠肾脏，以造福于亲人甚至陌生人。目前，大约有10万人生活在肾切除后。活体肾脏捐赠者不会从捐赠中获得任何医疗好处，他们也不会期望这样做。然而，活体捐赠者确实希望医学界了解肾脏捐赠的长期风险，以便选择捐赠者、知情同意和捐赠后护理。对于非裔美国人的肾脏捐赠者，到目前为止，我们在这方面是失败的。最大的肾脏捐赠者队列研究，移植社区对肾脏捐赠安全性的评估主要来自于不到1%的非裔美国捐赠者。然而，美国13%的活体捐赠者是非裔美国人，我们的初步发现表明，非裔美国人捐献后的死亡率、高血压、慢性肾脏疾病和终末期肾脏疾病的比率明显更高。不仅要估计这些疾病的风险，而且要了解捐赠造成的风险；然而，到目前为止，还没有一项研究捕捉到这一估计所必需的适当的非捐赠者控制措施。此外，许多非裔美国人捐赠者，特别是年轻捐赠者获得医疗保健的机会有限，重要的是要阐明在管理捐献后后果，如高血压和肾功能下降方面的潜在差距。鉴于非裔美国人在肾脏捐献后的长期结果和医疗保健方面存在显著的知识差距，我们建议估计非裔美国人与白人捐赠者高血压和肾脏疾病的发生率和后果。更重要的是，我们将通过比较捐赠者和健康的非捐赠者来确定这种风险在多大程度上可归因于捐赠肾脏(而不是基于人群的潜在风险差异)。我们还将评估行政数据来源在捕获和研究捐献后发病率方面的可靠性，并寻求更好地了解患有高血压或慢性肾脏疾病的捐赠者的治疗模式的种族差异。我们将通过招募最大的非洲裔美国人捐赠者的初级队列(来自美国前13个中心的4000多名捐赠者)、高加索捐赠者的比较队列以及符合捐赠资格标准但实际上没有捐赠的健康的非捐赠者来实现这些目标。我们将通过将国家注册数据与联邦医疗保险、医疗补助以及私人支付者索赔和药房数据联系起来来补充这些队列。我们的发现将对美国非裔美国人的活体肾脏捐赠实践产生直接影响，为捐赠者选择、捐赠的知情同意和捐赠后护理的关键方面提供信息。此外，这项研究将创造一个重要的资源，从中可以预见未来的几个辅助项目，包括对潜在捐赠者进行风险分层的基因分型，评估急性肾损伤和捐献后肾毒性药物的影响，以及估计肾脏捐赠者的终身保健成本和利用率。

DESCRIPTION (provided by applicant): Every year, over 6000 healthy individuals donate a kidney in the United States to benefit a loved one or even a stranger. Currently, approximately 100,000 individuals are living post-nephrectomy. Live kidney donors gain no medical benefit from donation, nor do they expect to. However, live donors do expect the medical community to understand the long-term risks of kidney donation, for the purposes of donor selection, informed consent, and post-donation care. For African American kidney donors, we have thus far failed in this regard. The largest cohort study of kidney donors, from which the transplant community's assessment of the safety of kidney donation has been primarily derived, was comprised of less than 1% African American donors. Yet 13% of live donors in the US are African American, and our preliminary findings suggest that rates of death, hypertension, chronic kidney disease, and end-stage renal disease following donation are significantly higher in African Americans. It is critical to not only estimate the risk of these diseases, but to understand the risk attributable t donation; however, no study to date has captured appropriate non-donor controls that are necessary for this estimation. Furthermore, many African American donors, particularly young donors, have limited access to healthcare, and it is important to elucidate potential disparities i the management of post- donation consequences such as hypertension and decline in kidney function. In light of a significant knowledge gap regarding long-term outcomes and medical care following kidney donation in African Americans, we propose to estimate the incidence and consequences of hypertension and kidney disease in African American versus Caucasian donors. More importantly, we will determine how much of that risk is attributable to donating a kidney (rather than population-based differences in underlying risk) by comparing donors to healthy non-donors. We will also evaluate the reliability of administrative data sources in capturing and studying post-donation morbidity, and seek to better understand racial differences in treatment patterns for donors who develop hypertension or chronic kidney disease. We will accomplish these goals by recruiting the largest primary cohort of African American donors (over 4000 donors from the top 13 centers in the US), a comparison cohort of Caucasian donors, and healthy non-donors who met eligibility criteria for donation but did not actually donate. We will supplement these cohort with linkage of national registry data to Medicare, Medicaid, and private payer claims and pharmacy data. Our findings will have a direct impact on the practice of live kidney donation among African Americans in the US, informing critical aspects of donor selection, informed consent for donation, and post-donation care. In addition, this research will create an important resource from which several future ancillary projects are foreseeable, including genotyping to risk stratify potential donors, evaluating the effects of acut kidney injury and nephrotoxic drugs after donation, and estimating lifetime healthcare costs and utilization for kidney donors.