12/14 APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) Clinical Center

12/14 APOL1长期肾移植结果网络（APOLLO）临床中心

• 批准号: 10730991
• 负责人: Chi-yuan Hsu
• 金额: $ 37.01万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-25 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10730991
• 关键词: APOL1 gene; Acceleration; Acute; Address; African American; African ancestry; Albumins; Allografting; American; Antibodies; Apolipoproteins; Bacterial Infections; Biology; Biopsy; Blood; California; Chronic Kidney Failure; Clinical Data; Collaborations; Collection; Computerized Medical Record; Consent; Cost Savings; Counseling; Creatinine; DNA; Data; Databases; Disparity; Donor person; Education; Eligibility Determination; Enrollment; Ensure; Environmental Risk Factor; European; Evaluation; Face; Failure; Gene Mutation; Genes; Genetic; Genotype; Goals; Graft Survival; HLA Antigens; Hand; Health Care Costs; Immunosuppression; Individual; Infrastructure; Kidney; Kidney Failure; Kidney Transplantation; Lesion; Living Donors; Longterm Follow-up; Los Angeles; Measurement; Measures; Medical; Medical center; Observational Study; Organ; Organ Procurements; Outcome; Participant; Patients; Phase; Phenotype; Policies; Prevalence; Proteinuria; Quality of life; Recurrent disease; Registries; Renal function; Reporting; Research; Risk; Risk Factors; Role; Safety; San Francisco; Serum; Site; Slide; Specimen; Time; Transplant Recipients; Transplantation; United Network for Organ Sharing; United States National Institutes of Health; Universities; Urine; Variant; Virus Diseases; Work; clinical center; cohort; digital pathology; ethnic difference; follow-up; gene interaction; genetic risk factor; graft failure; graft function; high risk; improved; kidney biopsy; living kidney donor; member; novel; participant enrollment; post-transplant; primary outcome; programs; prospective; racial difference; recruit; repository; response; risk variant; secondary outcome; transplant registry

PROJECT SUMMARY 12/14 APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) Clinical Center We submit this application in response to RFA-DK-22-506. UCSF 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 as a risk factor for graft loss. Our Clinical Center has been a leader on the West Coast, collaborating with our sites at University of California Los Angeles, University of California Davis (UC Davis), California Pacific Medical Center (CPMC), Stanford University, and University of Southern California. In Phase 1 or APOLLO, we have successfully enrolled a total of 223 participants across these centers, with DNA specimens in hand for 221/223. Our site has overseen the careful collection of clinical data from the electronic medical record at our own site and those of our engaged centers to complete the APOLLO Consortium Data forms accurately and completely. 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 continues at our engaged sites, 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 at least two years after transplantation in APOLLO Phase 1. We will collect additional biospecimens for contribution to the biorespository as well as unstained biopsy slides as we have been doing through Phase 1. We will work with the Scientific Data and Coordinating Center to ensure return of genotype results to all study participants who desire this information. We will also continue to recruit living donors at our site. 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.

项目摘要 12/14 APOL1长期肾脏移植结果网络（Apollo）临床中心 我们根据RFA-DK-22-506提交此申请。 UCSF是阿波罗的当前成员 财团。该财团成立于2017年，与器官协会无缝合作 采购组织（AOPO）招募参与者参加肾脏迄今为止最大的观察性研究 移植接受者和供体评估APOL1基因突变是移植物损失的危险因素。我们的临床 中心一直是西海岸的领导者，与我们在加利福尼亚大学洛杉矶分校的网站合作 加利福尼亚大学戴维斯大学（加州大学戴维斯分校），加利福尼亚太平洋医疗中心（CPMC），斯坦福 大学和南加州大学。在第1阶段或阿波罗，我们成功地注册了 在这些中心的223名参与者中，有DNA标本为221/223。我们的网站已经监督了 从我们自己的网站和我们参与的电子病历中仔细收集电子病历的临床数据 中心以准确，完全完整地构成阿波罗联盟数据。在第二阶段，我们将 继续获取所有参与者的关键后续数据，并确保从 电子病历在我们参与的网站继续进行，以提供患者级的细节 联合组织共享网络（UNOS）和移植科学注册表维护的数据库 收件人（SRTR）。我们将确保在所有参与者中都测量尿白蛋白与造克汀的比率 站点，在阿波罗第1阶段移植后至少两年后的纵向随访时间点。我们将 收集额外的生物测量，以便对生物的贡献以及未染色的活检滑梯 一直在第1阶段进行。我们将使用科学数据和协调中心来确保 基因型结果的返回给所有希望此信息的研究参与者。我们还将继续招募 我们网站的活捐助者。阿波罗财团的延续将导致我们的重要进展 了解APOL1高风险状态及其对移植功能的影响以及APOL1的生物学 基因效应。