1-13 ApoL1 Genotypes in Kidney Donors and Long-Term Outcomes in Kidney Transplant Recipients 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。迈阿密大学迈阿密移植研究所， 杰克逊纪念医院是11号临床中心，目前是阿波罗联盟的成员。这 该联盟成立于2017年，旨在与器官采购协会无缝合作 组织(AOPO)招募参与者参加迄今最大规模的肾移植观察性研究 受者和供者评估肾供者APOL1基因突变作为移植物丢失的风险因素。我们的 临床中心一直是该州符合条件的受者和活体肾脏捐赠者的领导者和顶级登记者 佛罗里达州、波多黎各和加利福尼亚州的两个移植中心。这一点是通过非常密切的 所有现场绩效指标和研究协调员之间的协作。以下移植中心是CC11的一部分： 参与参与的中心有：迈阿密移植研究所、坦帕综合医院、梅奥诊所 佛罗里达大学杰克逊维尔分校；作为非参与中心参与的有：佛罗里达州奥兰多康奈特健康中心， 纪念医疗系统佛罗里达州布罗沃德医院，波多黎各Auxilio Mutuo医院，加利福尼亚州研究所 肾脏研究和加州大学欧文分校。在阿波罗的第一阶段，我们已经成功地同意 241名肾移植受者和20名活体捐赠者，220名受者(91%)和20名捐赠者手中有DNA (100%)，在所有中心。我们的网站监督了临床数据的仔细收集从电子 在我们自己的网站和子网站上填写医疗记录，以准确和 全部，97%到100%的数据录入在不同的数据点。在第二阶段，我们将继续获得关键的 跟踪所有参与者的数据，并确保完成电子病历的数据提取，以 提供联合器官共享网络(UNOS)维护的数据库中没有的患者级别的详细信息 和移植受者科学登记处(SRTR)。我们将确保尿白蛋白与肌酐的比率 在所有地点的所有参与者中进行测量，从最初开始至少两年的纵向跟踪时间点 阿波罗第一阶段的注册。迈阿密大学迈阿密移植研究所将继续收集 为生物库和未染色的活组织切片提供额外的生物检验剂 完成第一阶段。我们将与科学数据和研究中心(SDRC)合作，确保 所有想要了解这一信息的参与者都会得到基因分型结果。我们还将继续招募在世的捐赠者 迈阿密移植研究所。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 University of Miami, Miami Transplant Institute, Jackson Memorial Hospital is the Clinical Center 11 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 state of Florida, Puerto Rico and 2 transplant centers in California. This has been achieved through a very close collaboration between all site PIs and research coordinators. The following transplant centers are part of CC11: participating as engaged centers are: The Miami Transplant Institute, Tampa General Hospital, Mayo Clinic Jacksonville, the University of Florida; participating as non-engaged centers are: Advent Health Orlando Florida, Memorial Healthcare System Broward Hospital Florida, Auxilio Mutuo Hospital in Puerto Rico, California Institute of Renal Research and University of California, Irvine. In Phase 1 of APOLLO, we have successfully consented 241 kidney transplant recipients and 20 living donors, with DNA on hand in 220 recipients (91%) and 20 donors (100%), across all 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, with 97% to 100% of the data entry at various data points. In Phase 2, we will continue to obtain critical follow-up data on all participants and ensure completion of data abstraction from electronic medical record, 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 Miami, Miami Transplant Institute, 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 (SDRC) to ensure return of genotype results to all participants who desire this information. We will also continue to recruit living donors at the Miami Transplant Institute. 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.