ABSOLUTE PROTEINURIA OVER TIME WITH NEFECON VS PLACEBO IN PATIENTS WITH IMMUNOGLOBULIN A NEPHROPATHY: RESULTS FROM THE PHASE 3 NEFIGARD TRIAL

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Abstract Title *

ABSOLUTE PROTEINURIA OVER TIME WITH NEFECON VS PLACEBO IN PATIENTS WITH IMMUNOGLOBULIN A NEPHROPATHY: RESULTS FROM THE PHASE 3 NEFIGARD TRIAL

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Co-author 1

Heather N. Reich Heather.Reich@uhn.ca University of Toronto Division of Nephrology, University Health Network, Department of Medicine Toronto Canada *

Co-author 2

Brad H. Rovin Brad.Rovin@osumc.edu The Ohio State University Wexner Medical Center Division of Nephrology Columbus United States -

Co-author 3

Richard A. Lafayette czar@stanford.edu Stanford University Division of Nephrology, Department of Medicine Stanford United States -

Co-author 4

Russell Jones russell.jones@calliditas.com Calliditas Therapeutics AB Statistics Department Stockholm Sweden -

Co-author 5

Jonathan Barratt jb81@leicester.ac.uk University of Leicester College of Life Sciences Leicester United Kingdom -

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Introduction

Proteinuria reduction is a surrogate marker of immunoglobulin A nephropathy (IgAN) treatment effectiveness. The Kidney Disease: Improving Global Outcomes (KDIGO) 2025 guidelines for IgAN recommend absolute proteinuria of <0.5 g/day as a treatment goal (guidelines in place at the time of initiation of the NefIgArd trial recommended an absolute proteinuria target of <1.0 g/day). Nefecon is a targeted-release budesonide formulation approved for IgAN. Here, we present absolute proteinuria over time during the Phase 3 NefIgArd trial.

Methods

Patients were randomized 1:1 to 16 mg/day nefecon or placebo for 9 months, followed by 15 months off treatment. Absolute urine protein–creatinine ratio (UPCR) changes from baseline over time were derived using results from the mixed-effect model for repeated measurement on the log-transformed data at Months 3, 6, 9, 12, 18, and 24, per the NefIgArd co-primary analysis of UPCR. The percentage change from baseline was then back-transformed using the baseline geometric mean UPCR per treatment group.

Results

Absolute geometric mean UPCR decreased by 33.6%, from 1.30 g/gram at baseline to 0.86 g/gram at 9 months with nefecon treatment, with continued reduction to 0.63 g/gram at 12 months (Figure). After Month 6 and up until Month 24, UPCR remained below 1 g/gram. UPCR was 1.26 g/gram with placebo at baseline and remained relatively stable over time (range 1.17-1.25 g/gram). UPCR response of ≤0.5 g/gram was achieved by 34.6% of patients receiving nefecon vs 10.4% receiving placebo.

Conclusion

In the NefIgArd trial, nefecon led to a substantial and sustainable reduction in proteinuria; no appreciable reduction was seen with placebo. Mean proteinuria levels below 1 g/gram were observed with nefecon from 6 months and continued throughout the off-treatment phase to Month 24.

This abstract was also submitted for the American Society of Nephrology Kidney Week 2025 congress.

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