7/14 APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) Clinical Center

项目总结 APOL1长期肾移植成果网络(阿波罗)临床中心 我们是根据RFA-DK-22-506的要求提交这份申请的。克利夫兰诊所和密歇根大学 成立临床中心7，这是阿波罗联盟的现任成员。这个财团是 成立于2017年，与器官采购组织协会(AOPO)无缝合作，以 招募参与者参加迄今为止最大规模的肾移植受者和捐赠者观察性研究，以评估 肾供者APOL1基因突变是移植物丢失的危险因素。我们的临床中心一直处于领先地位， 中西部地区符合条件的受赠者和活着的肾脏捐赠者的顶级登记者。这是通过一个 所有现场绩效指标和研究协调员之间的密切合作。以下移植中心是 CC7：俄亥俄州克利夫兰的克利夫兰诊所，佛罗里达州韦斯顿的克利夫兰诊所，密歇根大学圣彼得堡分校 密歇根州底特律约翰医院、密歇根州圣玛丽慈善健康医院、托莱多大学、密歇根大学 辛辛那提、俄亥俄州立大学、克利夫兰大学医院、匹兹堡大学医学中心、 纽约州立大学基金会/布法罗大学、亨利·福特健康系统和芝加哥大学。他们是 以订婚网站的身份参与。在阿波罗计划的第一阶段，我们已经成功同意了281例肾脏移植 受者和33名活体捐赠者，手头有246名受者(91%)和33名捐赠者(100%)的DNA 中锋。我们的网站监督了从电子病历中仔细收集临床数据的过程 自己的网站和子网站，以准确和完整地完成阿波罗联盟的数据表格。在第二阶段，我们 将继续获取所有参与者的关键后续数据，并确保完成数据提取 电子病历，提供美联航维护的数据库中没有的患者级别的详细信息 器官共享网络(UNOS)和移植受者科学登记处(SRTR)。我们将确保 在纵向随访时间点，测量所有参与者在所有部位的尿白蛋白/肌酐比率。 从最初的阿波罗第一阶段开始至少两年。密歇根大学和克利夫兰大学 诊所将继续收集更多的生物检疫剂，用于对生物库的贡献以及未染色的 就像我们在第一阶段所做的那样。我们将与科学数据和研究中心合作 以确保将基因分型结果返回给所有需要此信息的参与者。我们还将继续招聘 我们现场的活体捐赠者。阿波罗联盟的继续将在我们的 APOL1高危状态及其对移植物功能和APOL1基因生物学的影响 效果。

PROJECT SUMMARY APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) Clinical Center We submit this application in response to RFA-DK-22-506. The Cleveland Clinic and the University of Michigan form the Clinical Center 7 which is a current member of the APOLLO Consortium. This Consortium was established in 2017 to work seamlessly with the Association of Organ Procurement Organizations (AOPO) to enroll participants in the largest observational study to date of kidney transplant recipients and donors to evaluate APOL1 gene mutations in kidney donor as a risk factor for graft loss. Our Clinical Center has been a leader and top enroller for eligible recipients and living kidney donors in the Midwest. This has been achieved through a very close collaboration between all site PIs and research coordinators. The following transplant centers are part of CC7: Cleveland Clinic in Cleveland, Ohio, Cleveland Clinic in Weston, Florida, University of Michigan, Saint John’s Hospital in Detroit Michigan, Mercy Health St. Mary’s in Michigan, University of Toledo, University of Cincinnati, Ohio State University, University Hospitals of Cleveland, University of Pittsburgh Medical Center, SUNY Foundation/University of Buffalo, Henry Ford Health System and University of Chicago. They are participating as engaged sites. In Phase 1 of APOLLO, we have successfully consented 281 kidney transplant recipients and 33 living donors, with DNA on hand in 246 recipients (91%) and 33 donors (100%), across these centers. Our site has overseen the careful collection of clinical data from the electronic medical record at our own site and subsites to complete the APOLLO Consortium Data Forms accurately and entirely. In Phase 2, we will continue to obtain critical follow-up data on all participants and ensure completion of data abstraction from electronic medical records, to provide patient-level detail not available in databases maintained by United Network for Organ Sharing (UNOS) and the Scientific Registry of Transplant Recipients (SRTR). We will ensure a urine albumin-to-creatinine ratio is measured in all participants, at all sites, at a longitudinal follow-up time point of at least two years from original enrollment in APOLLO Phase 1. The University of Michigan and The Cleveland Clinic will continue to collect additional biospecimens for contribution to the biorepository as well as unstained biopsy slides as we have been doing through Phase 1. We will work with the Scientific Data and Research Center to ensure return of genotype results to all participants who desire this information. We will also continue to recruit living donors at our sites. Continuation of the APOLLO Consortium will lead to important advances in our understanding of APOL1 high-risk status and its influence on graft function as well as the biology of APOL1 gene effects.