The Nephrotic Syndrome Study Network (NEPTUNE) is a collaborative investigational infrastructure of 26 sites across North America for conducting clinical and translational research on rare kidney diseases presenting as Nephrotic Syndrome (NS): Focal and Segmental Glomerular Sclerosis (FSGS), Minimal Change Disease (MCD), and Membranous Nephropathy (MN). The NEPTUNE Administrative Core serves the primary role to manage and integrate all activities for clinical and translational research across the NEPTUNE sites. It is responsible for the overall development, implementation, and maintenance of the governance, policies, and infrastructure required for the clinical studies, pilot and ancillary studies program, career enhancement opportunities, and outreach activities in the network. Drs. Kretzler, Sedor, Holzman, Gipson, Gadegbeku, and Trachtman will represent the consortium leadership team. Dr. Kretzler will serve as PI of the consortium. Dr. Sedor will serve as Administrative Lead, directing day-to-day program planning, coordination, and evaluation of the network. Drs. Gadegbeku, Mariani, Sedor, Gipson, and Trachtman will co-lead the two longitudinal clinical studies, and Drs. Kretzler and Gipson will co-lead the Precision Medicine Study. Dr. Holzman will lead the Pilot/Ancillary and Career Enhancement Programs. Dr. Trachtman will serve as the Clinical Study Liaison, a role designed in NEPTUNE III to ensure cross-site engagement in Network activities. NephCure Kidney International (NKI) will provide critical leadership input from the patient perspective. The NEPTUNE Steering Committee (SC) will continue to be the central governance structure, consisting of voting members of the participating site PIs, patient advocacy groups, and funding partners at NCATS and NIDDK. The consortium will continue to assign subcommittees to help plan, implement, and monitor day-to-day activities that impact the success of the consortium core components. Additional task- or topic-specific working groups are nominated by consortium members to address specific needs and opportunities in the scope of NEPTUNE's mission. An independent group of experts in the areas of glomerular disease, precision medicine, biomarker development, and rare disease research will form an External Advisory Committee and will annually review and advise the Network on its scientific progress. Clinical protocols will be overseen by an OSMB to monitor research efforts and advise NEPTUNE investigators. Drs. Gillespie, Zee, and Troost will lead core biostatistical support, data management, and good data practices (GDP), and ensure cloud-ready datasets for use in the rare disease community. Dr. He will lead efforts to develop Common Data Elements in NEPTUNE and align with KPMP and other related projects with the same community-based integrative ontologies. Using the NEPTUNE Ancillary Study Policy, the consortium will engage public-private partnerships in research collaborations.
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