TY - JOUR
T1 - CureGN-Diabetes Study
T2 - Rationale, Design, and Methods of a Prospective Observational Study of Glomerular Disease Patients with Diabetes
AU - Mottl, Amy K.
AU - Bomback, Andrew S.
AU - Mariani, Laura H.
AU - Coppock, Gaia
AU - Jennette, J. Charles
AU - Almaani, Salem
AU - Gipson, Debbie S.
AU - Kelley, Sara
AU - Kidd, Jason
AU - Laurin, Louis Philippe
AU - Mucha, Krzysztof
AU - Oliverio, Andrea
AU - Palmer, Matthew
AU - Rizk, Dana
AU - Sanghani, Neil
AU - Stokes, M. Barry
AU - Susztak, Katalin
AU - Wadhwani, Shikha
AU - Nast, Cynthia C.
N1 - Publisher Copyright:
© 2023 The Author(s). Published by S. Karger AG, Basel.
PY - 2023/1
Y1 - 2023/1
N2 - Glomerular diseases (GDs) represent the third leading cause of end-stage kidney disease (ESKD) in the US Diabetes was excluded from the CureGN Study, an NIH/NIDDK-sponsored observational cohort study of four leading primary GDs: IgA nephropathy (IgAN), membranous nephropathy (MN), focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD). CureGN-Diabetes, an ancillary study to CureGN, seeks to understand how diabetes influences the diagnosis, treatment, and outcomes of GD. It is a multicenter, prospective cohort study, targeting an enrollment of 300 adults with prevalent type 1 or type 2 diabetes and MCD, FSGS, MN, or IgAN, with first kidney biopsy obtained within 5 years of enrollment in 80% (20% allowed if biopsy after 2010). CureGN and Transformative Research in DiabEtic NephropaThy (TRIDENT) provide comparator cohorts. Retrospective and prospective clinical data and patient-reported outcomes are obtained. Blood and urine specimens are collected at study visits annually. Kidney biopsy reports and digital images are obtained, and standardized pathologic evaluations performed. Light microscopy images are uploaded to the NIH pathology repository. Outcomes include relapse and remission rates, changes in proteinuria and estimated glomerular filtration rate, infections, cardiovascular events, malignancy, ESKD, and death. Multiple analytical approaches will be used leveraging the baseline and longitudinal data to compare disease presentation and progression across subgroups of interest. With 300 patients and an average of 3 years of follow-up, the study has 80% power to detect a HR of 1.4–1.8 for time to complete remission of proteinuria, a rate ratio for hospitalizations of 1.18–1.56 and difference in eGFR slope of 6.0–8.6 mL/min/year between two groups of 300 participants each. CureGN-Diabetes will enhance our understanding of diabetes as a modifying factor of the pathology and outcomes of GDs and support studies to identify disease mechanisms and improve patient outcomes in this understudied patient population.
AB - Glomerular diseases (GDs) represent the third leading cause of end-stage kidney disease (ESKD) in the US Diabetes was excluded from the CureGN Study, an NIH/NIDDK-sponsored observational cohort study of four leading primary GDs: IgA nephropathy (IgAN), membranous nephropathy (MN), focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD). CureGN-Diabetes, an ancillary study to CureGN, seeks to understand how diabetes influences the diagnosis, treatment, and outcomes of GD. It is a multicenter, prospective cohort study, targeting an enrollment of 300 adults with prevalent type 1 or type 2 diabetes and MCD, FSGS, MN, or IgAN, with first kidney biopsy obtained within 5 years of enrollment in 80% (20% allowed if biopsy after 2010). CureGN and Transformative Research in DiabEtic NephropaThy (TRIDENT) provide comparator cohorts. Retrospective and prospective clinical data and patient-reported outcomes are obtained. Blood and urine specimens are collected at study visits annually. Kidney biopsy reports and digital images are obtained, and standardized pathologic evaluations performed. Light microscopy images are uploaded to the NIH pathology repository. Outcomes include relapse and remission rates, changes in proteinuria and estimated glomerular filtration rate, infections, cardiovascular events, malignancy, ESKD, and death. Multiple analytical approaches will be used leveraging the baseline and longitudinal data to compare disease presentation and progression across subgroups of interest. With 300 patients and an average of 3 years of follow-up, the study has 80% power to detect a HR of 1.4–1.8 for time to complete remission of proteinuria, a rate ratio for hospitalizations of 1.18–1.56 and difference in eGFR slope of 6.0–8.6 mL/min/year between two groups of 300 participants each. CureGN-Diabetes will enhance our understanding of diabetes as a modifying factor of the pathology and outcomes of GDs and support studies to identify disease mechanisms and improve patient outcomes in this understudied patient population.
KW - Cure Glomerulonephropathy Network
KW - Diabetes
KW - Focal segmental glomerulosclerosis
KW - Glomerular disease
KW - IgA nephropathy
KW - IgA vasculitis
KW - Membranous nephropathy
KW - Minimal change disease
UR - http://www.scopus.com/inward/record.url?scp=85213830129&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85213830129&partnerID=8YFLogxK
U2 - 10.1159/000531679
DO - 10.1159/000531679
M3 - Article
AN - SCOPUS:85213830129
SN - 2673-3633
VL - 3
SP - 155
EP - 164
JO - Glomerular Diseases
JF - Glomerular Diseases
IS - 1
ER -