Limited Competition for the Continuation of Cure Glomerulonephropathy (CureGN) Participating Clinical Centers (U01 Clinical Trial Not Allowed)

archived

The purpose of this Limited Competition is to extend the Cure Glomerulonephropathy (CureGN) Network by continuing to support the Participating Clinical Centers (PCCs). The CureGN Network is a multicenter observational cohort study of glomerular disease patients with the goal of improving care for all glomerular disease patients. The operational components of the study include four multi-site PCCs and a Data Coordinating Center (DCC). The CureGN Network, established in 2013, has recruited nearly 2,200 of 2,400 planned study participants and followed them with annual in-person clinic visits and interim telephone contacts. The CureGN PCCs will continue to follow-up previously enrolled participants. The PCCs will optimize retention strategies, developing novel methods for "remote" or "virtual" study participation; ensure complete and accurate data collection with a focus on clinical assessment of disease activity and outcomes; and participate in the development and validation of study-wide semi-quantitative assessment of histopathologic lesions. It is expected that a focus on disease features unique to glomerulonephropathy, and outcomes relevant to the full range of patient experience, combined with carefully curated clinical and biochemical data will uncover new predictors of the disease course, pathophysiologic processes, disease subtypes and novel treatment targets.The DCC provides key leadership functions for this study in the areas of study organization, study design and implementation, overall management, data management and analysis, and biosample management. The DCC requirements are described under a separate FOA.

High