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

项目摘要 APOL 1长期肾移植结局网络（APOLLO）临床中心 我们根据RFA-DK-22-506提交本申请。克利夫兰诊所和密歇根大学 成立了临床中心7，该中心是APOLLO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， 招募参与者参加迄今为止最大的肾移植受者和供体观察性研究， APOL 1基因突变是肾移植失败的危险因素我们的临床中心一直是领导者， 是中西部合格受者和活体肾脏捐赠者的最佳招募者。这是通过一个 所有研究中心PI和研究协调员之间的密切合作。以下移植中心是部分 CC 7：位于俄亥俄州克利夫兰的克利夫兰诊所、位于佛罗里达韦斯顿的克利夫兰诊所、密歇根大学圣 密歇根州底特律的约翰医院，密歇根州的Mercy Health St.玛丽医院，托莱多大学， 辛辛那提，俄亥俄州州立大学，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、亨利福特卫生系统和芝加哥大学。他们是 作为参与网站参与。在APOLLO的第一阶段，我们已经成功地同意了281例肾移植。 接受者和33名活体捐赠者，其中246名接受者（91%）和33名捐赠者（100%）手头有DNA， 中心.我们的研究中心监督了从我们的电子病历中仔细收集临床数据的工作。 自己的网站和子网站，以完成APOLLO联盟数据表准确和完整。在第二阶段，我们 将继续获得所有参与者的关键后续数据，并确保完成数据提取， 电子医疗记录，以提供联合国数据库中无法提供的患者详细信息 器官共享网络（UNOS）和移植接受者科学登记处（SRTR）。我们将确保 在纵向随访时间点，在所有研究中心测量所有参与者的尿白蛋白/肌酐比值 距离APOLLO第1阶段最初入组至少两年。密歇根大学和克利夫兰大学 诊所将继续采集额外的生物标本，用于生物储存库以及未染色标本 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， 以确保将基因型结果返回给所有需要该信息的参与者。我们还将继续招聘 活体捐赠者阿波罗联盟的继续将导致我们的重要进展， 了解APOL 1高风险状态及其对移植物功能的影响以及APOL 1基因的生物学 方面的影响.

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.