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.

Public Health Relevance

Primary glomerular disease causes significant suffering, chronic health challenges, and progressive loss of kidney function over many years contributing to 10% of new end stage kidney disease (ESRD) patients per year in the USA. Despite the health burden imposed by glomerular disease, significant gaps exist in diagnosis, monitoring, and research that supports the effective treatment of these conditions. The primary glomerular disease (GDPrime) consortium will focus on four of those diseases, minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), immunoglobulin A nephropathy (IGAN), and idiopathic membranous nephropathy (IMN). The GDPrime consortium will establish a comprehensive research program centered around a prospective, observational cohort study of 2400 cases and 2400 controls. The resources generated by this study will support a collaborative research program involving many areas of science and medicine, empower the network of scientists working with the consortium to accelerate their research based on the rich resources provided through the accumulated cohort, specimens, scientific and analytic capacity managed through the data coordinating center (DCC). Success of the GDPrime consortium will be measured by advances in disease mechanisms and therapeutic pathways, identification and validation of outcomes relevant to patients as well as clinicians, early phase testing of novel therapies and effective public-private-patient advocate partnership across disciplines.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
1UM1DK100845-01
Application #
8627358
Study Section
Special Emphasis Panel (ZDK1-GRB-6 (O1))
Program Officer
Flessner, Michael Francis
Project Start
2013-09-16
Project End
2018-05-31
Budget Start
2013-09-16
Budget End
2014-05-31
Support Year
1
Fiscal Year
2013
Total Cost
$702,335
Indirect Cost
$95,497
Name
University of Michigan Ann Arbor
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
073133571
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109