Minnesota Precision Medicine CKD & Resilient Diabetes Recruiting Site: Engagement, Enrollment & Ethics

项目摘要 慢性肾脏病（CKD）是一种重要的健康问题，与高发病率和死亡率相关。 解开与CKD风险或保护相关的机制将显著推进精确的 CKD的预防、诊断和治疗的医学方法。 Minnesota-KPMP（Minn-KPMP）将道德和安全地获得研究肾活检，生物样本， 来自由于糖尿病或高血压导致的CKD的良好表型参与者和来自没有 CKD的临床表现，尽管数十年的1型糖尿病（T1 D）。在一个高度多样化的大都市区 积极面对种族主义和不平等，Minn-KPMP将吸引不同的患者群体进行评估， 解决KPMP注册的障碍，并征求我们当地参与者对伦理问题的看法 KPMP提出的问题，如结果返回和生物库管理。这将显着增加KPMP 社区参与和道德。 利用明尼苏达大学的生物医学信息学和数据访问服务， 翻译科学研究所（CTSI）最佳实践集成信息学核心（BPIC），我们将询问 大型MHealth Fairview（MHealth）数据库，用于识别、招募、登记和获取临床数据、生物样本， CKD-糖尿病和CKD-高血压和高血压-T1 D患者的肾活检。我们将密切合作 与KPMP，并帮助完善和遵循共同的研究协议，同时遵循最大的安全预防措施。 我们的团队在招募患者参加CKD临床试验方面的长期成功记录，以及我们的 同意进行肾活检的严格伦理方法和严格遵守KPMP安全措施将 确保我们对KPMP的使命和目标做出有意义的贡献。 Minn-KPMP组建了一支由调查人员和顾问组成的优秀团队， CKD和弹性T1 D（Res-T1 D）参与者。与此应用直接相关的是Minn-KPMP 研究团队在成功招募、随访以及安全和道德方面有着长期的跟踪记录 在广泛的参与者中进行研究性肾活检，包括连续肾活检， 包括糖尿病患者和无CKD临床表现的受试者、糖尿病兄弟姐妹、肾功能不全的受试者。 供者、肾移植受者和胰腺移植受者。获得高质量的生物样品， 包括肾活检样本，从良好的表型研究参与者是KPMP成功的关键，所以这些 组织可用于转录组学、蛋白质组学和代谢组学分析。Minn-KPMP渴望， 充分准备与其他KPMP招募中心、组织询问中心、中心枢纽、指导中心 委员会，DSMB，外部专家小组和KPMP的近300名成员。

PROJECT SUMMARY Chronic kidney disease (CKD) is an important health problem associated with high morbidity and mortality. Unraveling the mechanisms associated with risk of or protection from CKD will significantly advance a precision- medicine approach to CKD prevention, diagnosis, and treatment. The Minnesota-KPMP (Minn-KPMP) will ethically and safely obtain research kidney biopsies, biosamples, and data from well phenotyped participants with CKD due to diabetes or hypertension and from patients with no clinical manifestations of CKD despite decades of type 1 diabetes (T1D). In a highly diverse metropolitan area actively confronting racism and disparities, Minn-KPMP will engage a diverse patient population to evaluate and address barriers to enrollment in KPMP and to elicit the perspectives of our local participants on ethical issues posed by the KPMP, such as return of results and biobank governance. This will add significantly to KPMP community engagement and ethics. Leveraging the Biomedical Informatics and Data Access service of the University of Minnesota Clinical and Translational Science Institute (CTSI) Best Practices Integrated Informatics Core (BPIC), we will interrogate the large MHealth Fairview (MHealth) database to identify, recruit, enroll, and obtain clinical data, biosamples, and kidney biopsies from patients with CKD-Diabetes and CKD-Hypertension and resilient-T1D. We will work closely with KPMP and help to refine and follow common study protocols while following maximum safety precautions. The long-standing successful track record of our group in recruiting patients into clinical trials of CKD, and our ethically rigorous approach to consenting for kidney biopsy and strict adherence to KPMP safety measures will ensure our meaningful contribution to the KPMP mission and goals. Minn-KPMP has assembled an outstanding team of investigators and consultants to recruit and follow participants with CKD and with resilient T1D (Res-T1D). Directly relevant to this application, the Minn-KPMP study team has a long-standing track record of successfully recruiting, following-up, and safely and ethically performing research kidney biopsies, including sequential kidney biopsies, in a wide range of participants, including participants with diabetes and with no clinical manifestations of CKD, siblings with diabetes, kidney donors, kidney transplant recipients, and pancreas transplant recipients. Obtaining high quality biosamples, including kidney biopsy samples, from well phenotyped study participants is key to KPMP success, so that these tissues can be used for transcriptomic, proteomic, and metabolomic analyses. The Minn-KPMP is eager and fully prepared to collaborate with the other KPMP recruiting sites, tissue interrogation sites, central hub, steering committee, DSMB, external expert panel, and the almost 300 members of the KPMP.