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Living Donor Extended Time Outcomes (LETO) Study

活体捐赠者延长时间结果 (LETO) 研究

基本信息

批准号：
10164513
负责人：
Chi-yuan Hsu
金额：
$ 84.41万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-06-01 至 2024-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10164513
关键词：
Address Adoption Advocate African American Altruism American Americas Apolipoproteins Attenuated Biological Black race Characteristics Chronic Disease Chronic Kidney Failure Data Data Analyses Donor Selection Donor person End stage renal failure Enrollment Exclusion Financial cost Genes Genetic Genotype Glomerular Filtration Rate Health Health Insurance Health Status Home environment Hybrids Incidence Kidney Kidney Diseases Kidney Failure Kidney Transplantation Lead Light Living Donors Longterm Follow-up Mediating Medical Modeling Morals Natural History Nephrectomy Outcome Outcome Study Parents Patients Persons Policies Politics Prevalence Probability Process Race Registries Research Research Design Risk Risk Factors Sampling Socioeconomic Status Time Visit Waiting Lists adverse outcome base caucasian American clinical care clinical risk clinically significant comorbidity cost effective disparity reduction follow-up health disparity high risk improved improved outcome lifetime risk living kidney donor modifiable risk non-genetic racial disparity recruit response risk variant screening tool treatment choice

项目摘要

PROJECT SUMMARY We are submitting this competitive revision application in response to NOT-DK-20-012 to expand our existing R01DK120551 project titled “Living donor Extended Time Outcomes (LETO).” The parent LETO study will recruit a national sample of 1,100 black living kidney donors to assess their health status ~15-20 years after donation. The primary aim of the original application is to determine in a national sample whether black living kidney donors with 2 apolipoprotein L1 gene (APOL1) renal-risk variants are at higher risk of developing clinically significant chronic kidney disease (estimated glomerular filtration rate <45 ml/min/1.73m2) approximately two decades after donation.” Only black donors are targeted for enrollment into the parent LETO study. In this revision R01DK120551 application, we propose to add enrollment of 500 white living kidney donors, which will convert LETO into a powerful research platform to study racial disparities. This expansion will allow us to address a new aim: to quantify and compare the risk of developing clinically significant chronic kidney disease approximately two decades after donation in a national sample of black vs. white living kidney donors, and to quantify the relative importance of biologic (genetic, unmodifiable) vs. non- biologic (non-genetic, potentially modifiable) factors contributing to any observed health disparity. We will use the same cost-effective “hybrid” study design—jointly analyzing data collected at home-based research visits together with data collected as part of clinical care (as entered into a national registry)—that greatly increases the number of person-years of follow-up and enhances study power. We believe that findings from this study will strongly advocate for the adoption of policies such as such as mechanisms for improved long-term follow-up and provision of lifelong health insurance to living donors--justified not only as a moral imperative but also as a powerful tool to reduce racial disparities in access to living donor transplant.

项目摘要我们根据NOT-DK-20-012提交此竞争性修订申请，以扩展我们现有的 R 01 DK 120551项目名为“活体供者延长时间结局（LETO）”。母LETO研究将招募全国1,100名黑人活体肾脏捐赠者的样本，以评估他们捐赠后约15-20年的健康状况。最初申请的主要目的是在全国样本中确定黑人活体肾脏捐赠者是否携带2个载脂蛋白L1基因（APOL 1）的肾脏风险变异体发生临床显著性慢性肾脏疾病（估计肾小球滤过率<45 ml/min/1.73m2）约20年后捐赠。” 只有黑人供体才能入组母LETO研究。在本修订版R 01 DK 120551中申请，我们建议增加500名白色活体肾脏捐赠者的入组，这将使LETO成为一个强大的研究平台来研究种族差异。这一扩展将使我们能够实现一个新的目标：量化和比较临床发展的风险。在全国黑人与黑人的样本中，白色活体供肾者，并量化生物学（遗传学，不可改变）与非生物学（遗传学，不可改变）的相对重要性。造成任何观察到的健康差异的生物（非遗传的、可能改变的）因素。我们将采用同样具有成本效益的“混合”研究设计--联合分析在家庭基础上收集的数据研究访视以及作为临床护理的一部分收集的数据（输入国家登记系统）- 大大增加了随访的人年数，并增强了研究效力。我们认为，这项研究的结果将有力地倡导采取诸如以下政策：改进长期后续行动和向活体捐献者提供终身健康保险的机制-有理由这不仅是一种道德义务，而且是减少获得活体捐赠者方面种族差异的一种有力工具移植