Kidney Precision Medicine Project - Patient Engagement

项目摘要摘要 目前对启动慢性肾脏病和慢性肾脏病的病理生理和社会经济过程的理解 他们进展到ESRD的途径知之甚少，导致治疗有限。有一个 使用联合疗法对CKD患者进行精确表型前瞻性研究的迫切需求 结合肾活检、临床、生物学和社会经济因素，发展个性化护理，改善患者状况 结果。在过去的四年里，我们在地方一级组建了一支高技能、跨学科的团队， 临床研究人员、内科科学家、临床医生、研究护士、患者权益倡导者和社区 顾问委员会。这个团队设计、实施并维持了一个非常成功、合乎道德和安全的 肾脏精准医学项目招募现场(RS)：1)我们执行了第一个KPMP联合体 2019年9月进行了肾脏活检，是该财团中第一个进行30次肾脏活检的RS， 成功招募临床诊断为高血压或糖尿病的慢性肾病患者，并 为研究方案和病理诊断提供足够的组织；2)我们收集并链接了 活检参与者的临床、生物学和社会经济数据；3)我们将工作重点放在非洲- 美国和拉丁裔人口的比例非常高，以解决CKD AS不成比例的负担 以及历史上没有将这些人群纳入NIH授权的临床研究，完成了 这些组的11例活检中有22例(73%)。在财团层面，我们的团队成员已经做出了 对淘汰管理计划的主要组织和业务方面作出有意义的贡献。 这项提案的主要目标将是确定人口、招募患者和获得临床 表型数据、生物样本和肾脏活检。为了实现这一目标，我们将1)确定、招募、注册和 每年从3个大型HS中活检34名患者，为51,996名CKD和糖尿病和/或 高血压和纵向跟踪；2)实施伦理健全、系统质量保证 年从慢性肾脏病患者获得临床和人口学数据、生物样本和肾脏活检的过程 一项纵向临床研究；以及3)开发和实施以患者为中心的流程，以促进长期的 KPMP研究参与者的参与度和保留率。我们作为招聘网站的成功记录 取自因糖尿病或高血压引起的慢性肾脏病患者的肾脏组织 患者群体使我们成为KPMP继续实施的理想场所。我们招募病人的能力来自 具有新的信息学工具的多个医疗系统，以伦理严格的方法同意肾脏移植 活组织检查和严格安全的方法学是我们为KPMP带来的强大组合。我们的 这一FOA的创新方法不仅将提供数据来产生新的知识，从而改善 CKD的诊断和治疗，也可作为未来肾脏精准医学倡议和 它们会随着时间的推移而扩张。

Project Summary Abstract The current understanding of the pathophysiologic and socio-economic processes that initiate CKD and the paths by which they progress to ESRD are poorly understood, resulting in limited treatments. There is a compelling unmet need for prospective studies to accurately phenotype patients with CKD using a combination of kidney biopsy, clinical, biologic, and socioeconomic factors to develop individualized care to improve patient outcomes. Over the past four years, at the local level we assembled a highly skilled, interdisciplinary team of clinical researchers, physician-scientists, clinicians, research nurses, patient advocates and a Community Advisory Board. This team designed, implemented and sustained a highly successful, ethically sound and safe recruitment site (RS) for the Kidney Precision Medicine Project: 1) We performed the very first KPMP consortium kidney biopsy in September 2019 and were the first RS in the consortium to perform 30 kidney biopsies, successfully enrolling patients with a clinical diagnosis of hypertensive or diabetic chronic kidney disease and yielding sufficient tissue for research protocols as well as for pathological diagnosis; 2) We collected and linked clinical, biological and socioeconomic data of the biopsy participants; 3) We focused our efforts on African- American and Latinx populations at a very high rate in order to address the disproportionate burden of CKD as well as the historical lack of inclusion of these populations in cljnical research, mandated by the NIH, completing 22 out of 11 (73%) of biopsies among these groups. At the consortium level our team members have made meaningful contributions to the major organizational and operational aspects of KPMP. The main goal in this proposal will be population identification, patient recruitment and obtaining clinical phenotype data, biosamples and kidney biopsies. To accomplish this goal we will 1) Identify, recruit, enroll, and biopsy 34 patients annually from 3 large HS serving more than 51,996 patients with CKD and diabetes and/ or hypertension and follow patients longitudinally; 2) Implement ethically-sound, systematic quality-assured processes to obtain clinical and demographic data, bio-samples and kidney biopsies from patients with CKD in a longitudinal clinical study; and 3) Develop and implement patient-centered processes to promote long-term engagement and retention of study participants in KPMP. Our successful track record as a recruitment site for procurement of kidney tissue from patients with CKD attributed to diabetes or hypertension from a large, diverse patient population makes us an ideal site for the continuation of the KPMP. Our ability to recruit patients from multiple health systems with novel informatics tools, an ethically rigorous approach to consenting for kidney biopsy and coupled with a rigorous and safe methodology is a powerful combination we bring to the KPMP. Our innovative approach to this FOA will not only provide the data to generate new knowledge to improve both the diagnosis and treatment of CKD, but also serve as a model for future kidney precision medicine initiatives and their expansion over time.