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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：
10413009
负责人：
Chi-yuan Hsu
金额：
$ 56.47万
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/10413009
关键词：
Address African American African American population African ancestry American Ancillary Study Apolipoproteins Biometry Calendar Caring Cessation of life Chronic Kidney Failure Communities Data Data Analyses Donor Exclusions Donor Selection Enrollment Epidemiology European Evaluation Genes Genetic Genotype Glomerular Filtration Rate Goals Graft Survival Guidelines Health Heterozygote Home Hybrids Informed Consent Kidney Kidney Diseases Kidney Failure Kidney Transplantation Knowledge Living Donors Longitudinal Studies Organ Procurements Other Genetics Outcome Outcome Study Parents Patients Persons Publishing Registries Renal function Reporting Research Research Design Research Priority Retrospective Studies Risk Safety Sampling Societies Time Transplant Recipients Transplantation Uncertainty United States National Institutes of Health Visit adverse outcome base clinical care clinical practice clinical risk clinically significant cohort cost effective design follow-up genetic risk factor genetic variant high risk improved innovation ischemic injury kidney allograft living kidney donor novel programs prospective risk variant symposium trend

项目摘要

PROJECT SUMMARY We submit this proposal titled “Living donor Extended Time Outcomes (LETO)” as an ancillary study to the newly initiated “APOL1 Long-term Kidney Transplantation Outcomes” (APOLLO) Network. The APOLLO Consortium represents the most ambitious national study addressing the implications of donor apolipoprotein L1 gene (APOL1) renal-risk variants on kidney transplant outcomes. However, the prospective design of the parent APOLLO is underpowered to assess postdonation kidney health in living donors and outcomes in recipients of their kidneys due to due to short follow-up duration and secular trends resulting in diminishing numbers of persons with 2 APOL1 renal-risk variants donating in recent calendar years. We propose a 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 will greatly increase the number of person-years of follow-up and enhance study power. We will enroll 1,100 living donors who donated from 2001-2005 to generate data that will have a major impact on the clinical practice of living kidney donation in African Americans. Our specific aims are: Aim 1: To determine in a nationally representative sample whether African American living kidney donors with 2 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. Aim 2: To determine whether other independent (or APOL1 interactive) gene variants associate with increased risk of clinically significant chronic kidney disease (estimated glomerular filtration rate <45 ml/min/1.73m2) in African American living kidney donors. Aim 3: To determine the impact of donor APOL1 renal-risk variants and other novel genetic risk factors on graft survival and recipient outcomes in a nationally representative sample of living donor kidney transplant recipients from African American living donors.

项目摘要我们提交这份题为“活体供者延长时间结局（LETO）”的提案，作为对新的启动了“APOL 1长期肾移植结果”（APOLLO）网络。阿波罗联盟代表了最雄心勃勃的国家研究，解决供体载脂蛋白L1基因的影响，（APOL 1）肾风险变异对肾移植结果的影响。然而，父母的前瞻性设计 APOLLO在评估活体捐赠者的捐赠后肾脏健康状况和由于随访时间短和长期趋势，最近几年捐献的有2个APOL 1肾脏风险变异的人。我们提出了一个具有成本效益的“混合” 研究设计-共同分析在家庭研究访问中收集的数据以及作为一部分收集的数据临床护理（如进入国家登记册）-这将大大增加人年的数量，跟进，增强学习动力。我们将招募1，100名2001-2005年捐赠的活体捐赠者，这些数据将对非裔美国人活体肾脏捐赠的临床实践产生重大影响。我们具体目标是：目的1：确定在全国代表性样本中，非裔美国人活体肾脏供体是否具有2 APOL 1肾脏风险变体发生临床显著慢性肾脏疾病的风险较高（估计肾小球滤过率<45 ml/min/1.73m2）。目的2：确定其他独立的（或APOL 1相互作用的）基因变异是否与增加的有临床意义的慢性肾病风险（估计肾小球滤过率<45 ml/min/1.73 m2）非裔美国人活体肾脏捐赠者目的3：确定供者APOL 1肾风险变异和其他新的遗传风险因素对移植物的影响。全国代表性活体供肾移植受者的生存和受者结局非裔美国人活体捐赠者