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.