Kidney Health Initiative

项目总结/摘要 肾脏健康倡议（KHI）是美国肾脏病学会与美国肾脏病学会之间的公私合作伙伴关系。 (ASN)以及美国食品药品监督管理局（FDA）沿着肾脏领域的主要利益相关者 （患者、医疗保健专业人员、行业和政府成员）。KHI将解决许多问题 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）分子途径和靶点定义不明确（c） 肾脏疾病的特征性动物模型和（d）缺乏明确定义的临床试验终点， 时间线最重要的是，我们相信肾脏健康倡议将确定和开发解决方案， 针对目前肾脏疾病的停滞。这些解决方案将包括阐明 临床试验终点，改善临床试验设计和执行，以开发诊断标志物和患者 注册，为与美国食品药品监督管理局（FDA）更密切的合作创造途径， 其他利益相关者，并提高对肾脏疾病的认识和资助。应用程序将概述 支持KHI的基础设施和项目以及年度利益相关者会议。KHI利用一个 在线门户网站，以收集其成员的项目提案。通过这个门户网站， 从提交之日起，并为成员提供一个机会，通过在线评论和增强 对话建议书由KHI董事会审查，并根据是否符合KHI标准进行评估。 在批准为正式的KHI项目之前，对项目的使命、影响和可行性进行评估。多学科工作组 填充以完成项目和应用程序，以服务于一个分布式计算系统是一个开放的过程，使用 KHI网站发布了一个呼吁，为会员。目前的赠款提案计划建立在最初的 KHI的成功，并将我们与FDA的合作提升到组织，范围， 和影响。

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.