Tuesday, February 17, 2026 2/17/2026

Clinical applications of urine proteomics to lupus nephritis

Award Number: R01DK134625
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: 03/01/2023
PERIOD OF PERFORMANCE END DATE: 12/31/2027

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Clinical applications of urine proteomics to lupus nephritis - Abstract Lupus nephritis (LN) is diagnosed by kidney biopsy in patients with proteinuria > 0.5g/24h, but the presence of proteinuria means that kidney damage has already occurred. It is estimated that 30% of nephrons are permanently lost with each flare of LN. The identification of LN before kidney damage using urine proteomic biomarkers could shift the management strategy of LN to prevention, potentially leading to earlier, more effective, and less toxic treatment. Three specific aims will be addressed in this R01 building on the work of the Hopkins Lupus Cohort (a 35 year, 2855 SLE longitudinal cohort in which patients are followed by protocol every 3 months) and in particular on the urine biomarker discoveries from the NIH RA/SLE Accelerated Medicines Partnership (AMP). Aim 1 - Develop a urine biomarker panel to identify new lupus nephritis BEFORE proteinuria. Previous AMP urine proteomic studies revealed that urinary IL-16, CD163, and neutrophil granule content indicate intrarenal LN activity. These biomarkers will be quantitated in urine samples collected within 3 months before the onset of proteinuria in lupus patients who ultimately were diagnosed with LN by renal biopsy to determine if the biomarkers are elevated compared to patients who do not develop LN. A full urine proteomic profile will also be assessed to discover additional biomarkers that could contribute to a robust panel for predicting onset of LN before proteinuria. Aim 2 - Develop a urine biomarker panel to guide tapering of immunosuppression in treated LN patients. Patients with a histological NIH activity index >2 on repeat biopsy developed a proteinuria flare and increased mortality upon tapering of immunosuppression in one study. Four urinary biomarkers associated with NIH activity index >2 in AMP (IL-16, CD163, Galectin-1, and PRTN3) will be quantitated ( with analysis of 1200 additional urine proteins) in urine samples from 12 LN patients in apparent clinical remission who flared upon tapering immunosuppression versus 12 LN patients who did not flare upon tapering. The most predictive biomarkers will be combined into a 10- plex panel to be validated in a prospective cohort of 60 patients tapering immunosuppression. Aim 3 - Develop a biomarker for detection of early chronic kidney disease (CKD) in LN. Urine proteomic studies on 187 patients enrolled in AMP identified TGF-β-mediated fibrosis and TNF signaling related proteins that may be superior to proteinuria alone in detecting early CKD. These AMP patients will be followed clinically for at least five years to determine the trajectory of their kidney disease and to find differences in urine proteomic (and other omic) profiles between those who maintain stable renal function versus those who do not.


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 = $725,944 )
2026	2026	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	1/16/2026	NON-COMPETING CONTINUATION	$725,944
														Subtotal = $725,944

Issue Date FY: 2025 ( Subtotal = $759,737 )
2025	2025	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	5/2/2025	NON-COMPETING CONTINUATION	$759,737
														Subtotal = $759,737

Issue Date FY: 2024 ( Subtotal = $665,224 )
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	12/14/2023	NON-COMPETING CONTINUATION	$623,650
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	5/3/2024	NON-COMPETING CONTINUATION	$41,574
														Subtotal = $665,224

Issue Date FY: 2023 ( Subtotal = $657,455 )
2023	2023	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	2/17/2023	NEW	$657,455
														Subtotal = $657,455

Grand Total All Awards = $2,808,360

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Clinical applications of urine proteomics to lupus nephritis

Award Number: R01DK134625

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: 03/01/2023

PERIOD OF PERFORMANCE END DATE: 12/31/2027

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