Kidney Health Initiative is a public-private partnership between the American Society of Nephrology, US Food and Drug Administration and the kidney community.

项目概要/摘要 肾脏健康倡议 (KHI) 是美国肾脏病学会之间的公私合作伙伴关系 (ASN)、美国食品和药物管理局 (FDA) 以及肾脏界的所有主要利益相关者（患者、 医疗保健专业人员、行业和政府成员）。 KHI是肾脏领域最大的财团 社区，致力于解决新药、设备和生物制品开发的障碍 患有肾脏疾病的人。 KHI 董事会和项目工作组讨论并制定解决方案 针对会员和社区发现的障碍。解决方案包括但不限于 阐明临床试验终点、改进临床试验设计和执行、开发 诊断标志物和患者登记，为与美国食品和药物管理局更密切的合作创造途径 政府（FDA）和其他利益相关者，并提高人们的认识和包容性 肾脏疾病进入药物、设备和生物开发。该申请将概述对未来的支持 路线图和项目、扩大患者和家庭伙伴关系以及 KHI 基础设施，例如 项目提交流程和年度利益相关者会议。目前的拨款提案计划建立在 KHI 的初步成功并将我们与 FDA 在组织方面的合作提升到一个新的水平， 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), US Food and Drug Administration (FDA), and all major stakeholders in the kidney community (patients, healthcare professionals, members of industry and government). KHI is the largest consortium in the kidney community and is focused on addressing barriers to the development of new drugs, devices and biologics for people living with kidney disease. KHI's Board of Directors and project workgroups discuss and develop solutions for barriers as they are identified by the membership and community. Solutions include but are not limited to 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 inclusion of people living with kidney diseases into drug, device and biologic development. The application will outline support for the future roadmaps and projects, expansion of the patient and family partnership and KHI infrastructure, such as the project submission process and annual stakeholders meeting. 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.