Absolute Proteinuria over Time with Nefecon vs. Placebo in Patients with IgAN: Results from the Phase 3 NefIgArd Trial
Bibliographic record
Abstract
Background: Proteinuria reduction is a surrogate marker of immunoglobulin A nephropathy (IgAN) treatment effectiveness. Kidney Disease: Improving Global Outcomes (KDIGO) 2021 guidelines consider an absolute reduction to <1 g/day a “reasonable treatment target”. 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 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 versus 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. Funding: Commercial Support - Calliditas Therapeutics
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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 | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.003 | 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".