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CureGN-Diabetes Study: Rationale, Design, and Methods of a Prospective Observational Study of Glomerular Disease
Amy K Mottl1, Andrew S Bomback2, Laura H Mariani3
1UNC Kidney Center, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
Insights
This study investigates how diabetes impacts glomerular diseases (GDs) like IgA nephropathy and FSGS. Understanding these effects is crucial for improving outcomes in diabetic kidney patients.
Area of Science:
- Nephrology
- Endocrinology
- Diabetology
Background:
- Glomerular diseases (GDs) are a major cause of end-stage kidney disease (ESKD).
- Diabetes was previously excluded from major GD studies, leaving a knowledge gap.
- Diabetic kidney disease often complicates the management and prognosis of primary GDs.
Purpose of the Study:
- To investigate the influence of diabetes on the diagnosis, treatment, and outcomes of primary GDs.
- To compare disease presentation and progression in patients with and without diabetes.
- To identify mechanisms and improve patient outcomes in this understudied population.
Main Methods:
- Prospective, multicenter cohort study of 300 adults with type 1 or type 2 diabetes and primary GDs (IgAN, MN, FSGS, MCD).
- Collection of clinical data, patient-reported outcomes, biospecimens (blood, urine), and kidney biopsy data.
- Utilizing comparator cohorts (CureGN, TRIDENT) for comparative analysis.
Main Results:
- The study is powered to detect clinically significant differences in remission rates, hospitalizations, and eGFR decline.
- Longitudinal data analysis will compare disease presentation and progression across subgroups.
- Specific results on outcomes like relapse, proteinuria, eGFR changes, infections, cardiovascular events, and mortality are anticipated.
Conclusions:
- Diabetes significantly modifies the pathology and outcomes of primary glomerular diseases.
- Enhanced understanding is needed to improve diagnosis, treatment, and patient care.
- Further research will focus on disease mechanisms and therapeutic strategies for diabetic GD patients.
Abstract:
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.
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