Duration of Absolute Proteinuria Response with Nefecon in Patients with Primary IgAN: Results from the Two-Year NefIgArd Trial
Bibliographic record
Abstract
Background: Proteinuria reduction is a surrogate marker of improved kidney outcomes in immunoglobulin A nephropathy (IgAN), and the Kidney Disease: Improving Global Outcomes (KDIGO) 2021 guidelines consider an absolute reduction to <1 g/day a “reasonable treatment target.” Data from the 2-year placebo-controlled NefIgArd trial have shown sustained relative reductions in the urine protein–creatinine ratio (UPCR) from baseline with nefecon, a targeted-release budesonide formulation, in patients with IgAN (Barratt J, et al. ERA 2025 [abstract]). Here, we present NefIgArd data evaluating the effect of nefecon versus placebo on sustained absolute proteinuria response. Methods: In this Phase 3 trial, adults with IgAN, estimated glomerular filtration rate (eGFR) 35–90 mL/min/1.73 m2, and UPCR ≥0.8 g/gram despite optimized renin–angiotensin system inhibition (RASi), were randomized to receive nefecon 16 mg/day or placebo for 9 months, followed by 15 months off treatment. Optimized RASi was maintained throughout. Proportions of patients maintaining an absolute UPCR response, defined as UPCR ≤1 g/gram, for ≥6, ≥9, ≥12, and ≥18 months were determined. Results: Among nefecon-treated patients, 72% maintained an absolute UPCR response for ≥9 months, compared with 38% of patients in the placebo group (Table). Furthermore, 46% of patients receiving nefecon maintained an absolute UPCR response for ≥18 months compared with 21% of patients receiving placebo. Conclusion: Almost three-quarters of nefecon-treated patients maintained UPCR at or below the 1 g/gram threshold for at least 9 months, and almost half for at least 18 months. These data show that nefecon treatment enables a substantial proportion of patients to achieve absolute target proteinuria levels for sustained periods and experience improved kidney outcomes. Funding: Commercial Support - Calliditas Therapeutics Proportion of patients experiencing an absolute UPCR response (defined as UPCR ≤1 g/gram) for at least 6, 9, 12, and 18 months - Duration of UPCR ≤1 g/gram Nefecon 16 mg/day (N=182)n (%) Placebo (N=182)n (%) ≥6 months 147 (80.8) 92 (50.5) ≥9 months 131 (72.0) 69 (37.9) ≥12 months 126 (69.2) 62 (34.1) ≥18 months 84 (46.2) 39 (21.4)
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".