GDPrime

University Of Michigan At Ann Arbor, Ann Arbor MI

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by applicant): This Data Coordinating Center (DCC) application is submitted in response to RFA-DK-12-014 to establish a primary glomerular disease (GDPrime) consortium with a focus on minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), immunoglobulin A nephropathy (IGAN), and idiopathic membranous nephropathy (IMN). Taken together these diseases are responsible for significant symptom burden, chronic health challenges, and progressive loss of kidney function over 1 to 20 years contributing to 10% of incident end stage kidney disease (ESRD) patients per year in the USA. Despite the health burden imposed by primary glomerular disease, significant gaps in understanding disease pathophysiology, diagnosis, monitoring, prognosis and clinical trials exists and have prevented the implementation of effective therapy for these conditions. The GDPrime consortium will establish a comprehensive research platform centered around a prospective, observational cohort study of 2400 cases and 2400 controls. The overarching goal of the DCC application is to establish the data coordinating center to provide the study design, data management and analysis expertise for the consortium and associated ancillary studies. The GDPrime DCC will establish the infrastructure for conduct of the GDPrime study; coordinate the prospective longitudinal cohort study of children and adults with primary glomerular disease and healthy controls; define disease course and investigate predictors of outcomes in patients compared with non-disease controls and their associations with disease progression. The GDPrime DCC and overall consortium will establish a comprehensive ancillary study program for extramural collaboration and partnership to advance the identification and evaluation of novel biomarkers, therapeutic targets, outcome measures and as yet undefined research proposed by the scientific community at large.