CureGN

ABSTRACT Primary glomerular diseases, including minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), immunoglobulin A nephropathy (IgAN), and membranous nephropathy (MN), are associated with significant morbidity and mortality in both adults and children. The Cure Glomerulonephropathy (CureGN) is a prospective, longitudinal observational cohort study launched in 2013 to address critical knowledge gaps in the pathogenesis, natural history, and response to therapy of these heterogeneous disorders. It is a study of unprecedented size and remarkable depth, built by a unique collaborative interdisciplinary community. The international consortium includes researchers with diverse expertise, affected patients and advocacy groups, the biopharmaceutical industry, and federal funding agencies. CureGN has successfully recruited a diverse cohort of nearly 2,800 adult and pediatric participants with MCD, FSGS, IgAN and MN from more than 60 clinical study sites. Biospecimens, clinical data, and patient reported outcomes are collected to enable high- quality clinical, mechanistic, and translational investigations. This foundational work is being conducted by a collaborative infrastructure including the Data Coordinating Center (at the University of Michigan, Northwestern University and Cleveland Clinic) and four Participating Clinical Centers (managed at the University of Pennsylvania, Columbia University, University of North Carolina, and the Pediatric Nephrology Research Consortium). CureGN is paving the way for personalized care in glomerular disease by disentangling the heterogeneity within these disorders that are etiologically diverse but currently grouped into only four diagnoses. In CureGN's third study phase, we propose to maintain and enhance the CureGN Consortium infrastructure and ancillary studies program to accelerate patient-relevant glomerular disease research. We will continue our core observational study, enrolling additional participants in a recruit-to-replace strategy to maintain an active cohort of 2000 participants with high quality clinical data and biomaterials. We will utilize state of the art tools for remote data and biospecimen collection, expand biospecimen types, and implement the use of new mobile applications for patient engagement and medical record linkages. Mature scientific working groups, committees and ancillary infrastructure will continue to support a multidisciplinary core and ancillary study program to achieve the scientific goals of CureGN. We will continue our outreach to the scientific community by enhancing CureGN's role as an outstanding training vehicle for the next generation of glomerular disease researchers and attracting cutting-edge, established scientists to glomerular disease through opportunity pool grants, collaborations with patient advocacy groups and professional societies, training workshops and support of ancillary studies from academic and industry partners. Through this coordinated effort, CureGN is prepared to accelerate improvements in the care of patients with glomerular disease.