Kidney Health Initiative

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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.