Kidney Health Initiative

项目摘要/摘要 肾脏健康倡议(KHI)是美国肾脏学会之间的公私合作伙伴关系 (ASN)和美国食品和药物管理局(FDA)以及肾脏社区的主要利益相关者 (患者、医疗保健专业人员、行业和政府成员)。KHI将与许多人正面交锋 肾脏领域的创新障碍。这些问题包括：(A)对 肾脏疾病进展的发病机制(B)分子途径和靶点界定不清(C) 肾脏疾病动物模型的特点以及(D)缺乏明确界定的临床试验终点和 时间线。最重要的是，我们认为，肾脏健康倡议将确定和制定解决方案， 瞄准目前肾脏疾病内部的停滞。这些解决方案将包括澄清的机会 临床试验终点，改进临床试验设计和执行，以开发诊断标志物和患者 注册中心，为与美国食品和药物管理局(FDA)和 其他利益攸关方，并提高对肾脏疾病的认识和资助。该应用程序将概述 支持克什米尔重工的基础设施和项目，以及年度利益攸关方会议。KHI利用了一个 从其成员中收集项目建议书的在线门户网站。通过此门户，可以查看所有建议书 从提交之日起，并为成员提供在线评论和改进的机会 对话。建议由KHI董事会审查，并根据满足KHI的情况进行评估 在正式认可克什米尔重工项目之前，其使命、影响和可行性。由多学科组成的工作组有 填充以完成项目并将在工作组中服务的应用程序是使用 KHI网站上发布了对工作组成员的呼吁。目前的拨款建议计划在最初的基础上 KHI的成功，并将我们与FDA的合作在组织、范围方面更上一层楼 和冲击力。

Project Summary/Abstract The Kidney Health Initiative (KHI) is a public-private partnership between the American Society of Nephrology (ASN) and the US Food and Drug Administration (FDA) along with major stakeholders in the kidney community (patients, healthcare professionals, members of industry and government). KHI will address head on the many barriers to innovation within the kidney space. These include (a) an inadequate characterization of the pathogenesis of renal disease progression (b) poorly defined molecular pathways and targets (c) poorly characterized animal models of kidney disease and (d) the lack of well-defined clinical trial end points and timelines. Most importantly, we believe that the Kidney Health Initiative will identify and develop solutions that target the current stagnation within renal disease. These solutions would include opportunities to elucidate clinical trial endpoints, improve clinical trial design and execution, to develop diagnostic markers and patient registries, to create avenues for closer collaboration with the US Food and Drug Administration (FDA) and other stakeholders, and to advance awareness and funding of kidney disease. The application will outline support for the infrastructure and projects of KHI as well as the annual stakeholders meeting. KHI utilized an online portal to collect project proposals from their membership. Through this portal, all proposals are viewed from the day of submission and provide an opportunity for members to comment and enhance through online dialogue. Proposals are reviewed by the KHI Board of Directors and evaluated based on meeting the KHI mission, impact and feasibility before endorsement as an official KHI project. Multi-disciplinary workgroups are populated to complete the projects and the application to serve on a workgroup is an open process using the KHI website to post a call for workgroup members. The current grant proposal plans to build upon the initial successes of the KHI and take our collaboration with the FDA to the next level in terms of organization, scope and impact.