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Real-world Comparative Treatment Effectiveness and Surrogate Outcome Evaluation in Membranous Nephropathy using Observational Data

Award Number: R01DK144396
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: 05/15/2026
PERIOD OF PERFORMANCE END DATE: 02/28/2031

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Real-world Comparative Treatment Effectiveness and Surrogate Outcome Evaluation in Membranous Nephropathy using Observational Data - PROJECT SUMMARY Membranous nephropathy (MN) is an autoimmune glomerular disease that represents a major cause of nephrotic syndrome in adults and can also affect children. Patients with MN have substantial disease burden, with high risks of infection, thromboembolic events, cardiovascular complications, and kidney failure. While recent discoveries of target antigens for autoantibodies have accelerated understanding of MN biology, translation to treatment guidance is lacking. There are no FDA-approved treatments for MN and limited evidence exists for optimal use of currently available immunosuppression medications, since clinical trials are limited by small sample size, short follow-up, and a focus on short-term proteinuria outcomes. The overarching goal of this project is to emulate clinical trials by applying modern causal inference methods to observational data with long follow-up to fill these gaps in knowledge and inform future trial design. Specific Aims are to (1) estimate real-world comparative treatment effects on long-term clinical effectiveness and safety outcomes; (2) evaluate the prognostic value of the anti-phospholipase A2 receptor antibody (PLA2R-Ab) as a biomarker for long-term clinical outcomes, overall and within treatment subgroups; and (3) validate PLA2R-Ab as a surrogate endpoint for long-term clinical outcomes. Data from two observational cohort studies—the Nephrotic Syndrome Study Network (NEPTUNE) and Cure Glomerulonephropathy (CureGN)—and electronic health records from two registries—the Kidney Research Network (KRN) and Glomerular Disease Collaborative Network (GDCN)—will be pooled and analyzed using longitudinal matching, mediation analyses, and longitudinal and survival data analysis methods. Results from this study will provide evidence to nephrologists and patients to guide treatment decisions and optimize use of PLA2R-Ab for patient monitoring. Validation of PLA2R-Ab as a surrogate endpoint would provide early indications of treatment response to support disease management and facilitate shorter duration of clinical trials for future drug development.


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 = $949,759 )
2026	2026	THE CHILDREN'S HOSPITAL OF PHILADELPHIA	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	5/19/2026	NEW	$949,759
														Subtotal = $949,759

Grand Total All Awards = $949,759

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Real-world Comparative Treatment Effectiveness and Surrogate Outcome Evaluation in Membranous Nephropathy using Observational Data

Award Number: R01DK144396

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: 05/15/2026

PERIOD OF PERFORMANCE END DATE: 02/28/2031

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