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The Impact of Diabetes on Patients with Glomerular Disease: CureGN-Diabetes

Award Number: R01DK126959
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/11/2021
PERIOD OF PERFORMANCE END DATE: 01/31/2027

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The Impact of Diabetes on Patients with Glomerular Disease: CureGN-Diabetes - ABSTRACT Primary glomerular diseases often occur in patients with prexisting diabetes mellitus, a common and systemic illness which increases the risk for infection, cardiovascular and progressive chronic kidney disease. The diagnosis, pathology, treatment, complications and outcomes of primary glomerular diseases may be modified by the risks associated with diabetes, however, the literature is greatly lacking in this area. Such information is crucial to optimizing beneficial therapies and minimizing complications and cost in the care of glomerular disease patients. CureGN-Diabetes is a prospective, longitudinal observational study of patients with one of the four most common primary glomerular diseases: IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), and membranous nephropathy (MN). It is an ancillary study to the parent CureGN study which is currently in its second cycle of NIH/NIDDK funding and has enrolled 2400 patients with IgAN, FSGS, MCD and MN, but excluded patients with diabetes prevalent at the time of glomerular disease diagnosis. The exclusion of diabetes had an unexpected and disproportionate effect on recruitment among minorities and sites in the southeastern U.S., as these populations suffer among the highest rates of diabetes. CureGN-Diabetes will fill this gap in the CureGN study and will also leverage control data from the TRIDENT Study, a longitudinal cohort of patients with biopsy proven diabetic glomerulosclerosis. Harmonization of data from CureGN, TRIDENT and CureGN-Diabetes, will provide an opportunity to study the effects of primary glomerular disease alone, diabetic glomerulosclerosis alone and the combined effects of primary glomerular disease AND diabetes. The aims of CureGN-GN Diabetes include: 1) To recruit and follow a multiethnic cohort of 300 adult patients with diabetes mellitus and biopsy documented IgAN, FSGS, MN, and MCD; 2) To assess the impact of diabetes on presenting features (clinical and histopathologic) and long term outcomes in patients with IgAN, FSGS, MN, and MCD; AND 3) To identify individual and clusters of morphologic lesions which carry diagnostic and prognostic value. A strength of this study is the significant overlap between investigators and clinical sites involved in the CureGN and TRIDENT studies, which will expedite the efficiency and productivity emanating from this work. Furthermore, the CureGN-Diabetes Study will add to the available biorepositories of CureGN and TRIDENT, enriching the resources for future biomarker and mechanistic studies of primary glomerular disease versus diabetes-mediated pathways


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $611,941 )
2026	2026	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	5	1/16/2026	SUPPLEMENT FOR EXPANSION	$19,008
2026	2026	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	1/15/2026	NON-COMPETING CONTINUATION	$592,933
														Subtotal = $611,941

Issue Date FY: 2025 ( Subtotal = $611,522 )
2025	2025	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	8/23/2025	SUPPLEMENT FOR EXPANSION	$12,807
2025	2025	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	8/19/2025	NON-COMPETING CONTINUATION	$598,715
														Subtotal = $611,522

Issue Date FY: 2024 ( Subtotal = $605,141 )
2024	2024	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	3	7/8/2024	NON-COMPETING CONTINUATION	$0
2024	2024	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	5/29/2024	NON-COMPETING CONTINUATION	$37,821
2024	2024	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	4/11/2024	NON-COMPETING CONTINUATION	$567,320
														Subtotal = $605,141

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	3/14/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $651,102 )
2022	2022	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	3/1/2022	NON-COMPETING CONTINUATION	$585,990
2022	2022	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	2	4/22/2022	NON-COMPETING CONTINUATION	$65,112
2022	2021	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	2/10/2022	NEW	$0
														Subtotal = $651,102

Issue Date FY: 2021 ( Subtotal = $745,696 )
2021	2021	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	3/11/2021	NEW	$745,696
														Subtotal = $745,696

Grand Total All Awards = $3,225,402

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The Impact of Diabetes on Patients with Glomerular Disease: CureGN-Diabetes

Award Number: R01DK126959

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 03/11/2021

PERIOD OF PERFORMANCE END DATE: 01/31/2027

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