NeflgArd Open-Label Extension: Efficacy and Safety of Nefecon in Patients with IgAN Who Completed the 2-Year Phase 3 Trial
Bibliographic record
Abstract
Background: Nefecon was approved for the reduction of kidney function loss in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression, based on the 2-year NeflgArd trial findings (Lafayette. Lancet 2023;402:859). Nefecon 16 mg/d for 9 months (mo.) led to a statistically significant benefit in time-weighted average estimated glomerular filtration rate (eGFR) and a durable proteinuria reduction vs placebo. We report data from an open-label extension (OLE) study (NCT04541043) of the effect of Nefecon treatment (tx) in patients (pts) who completed the NeflgArd trial. Methods: This Phase 3b, multicenter, OLE enrolled pts with IgAN who completed the NeflgArd trial, with persistent proteinuria ≥1 g/d or urine protein–creatinine ratio (UPCR) ≥0.8 g/g and eGFR ≥30 mL/min/1.73 m2 despite optimized renin–angiotensin system blockade. Pts who completed a full 9-mo. course of Nefecon 16 mg/d without dose reductions were included. OLE pts received Nefecon 16 mg/d for 9 mo. (+2 wks’ tapering at 8 mg/d). Blinding to previous NefIgArd tx was maintained. Primary efficacy endpoints were the ratios of eGFR and UPCR at 9 mo. vs OLE baseline. Adverse events occurring during the OLE were captured as new or ongoing from the NefIgArd trial. Results: Of the 326 pts completing the NefIgArd trial, 119 entered the OLE (45 [38%] Nefecon-experienced; 74 [62%] Nefecon-naïve). 94 (79%) pts were men and 100 (84%) identified as white. At the OLE baseline, median eGFR in Nefecon-experienced vs Nefecon-naïve pts was 50.4 and 49.2 mL/min/1.73 m2, respectively; median UPCR was 1.28 and 1.37 g/g, respectively. For all 119 pts, UPCR reduction from baseline at 9 mo. was 32%, with an absolute eGFR decline of 1.43 mL/min/1.73 m2 also reported. In the OLE, similar UPCR reductions and eGFR changes after 9 mo. of Nefecon were seen in Nefecon-experienced and -naïve pts. Tx in the OLE was well tolerated without any new safety signals. Conclusion: These study findings provide valuable insights into the efficacy and safety of additional tx with Nefecon and demonstrate that, in pts previously treated with Nefecon, a second 9-mo tx course had an effect on proteinuria and kidney function decline similar to a first tx course, without additional safety concerns. Funding: Commercial Support - Calliditas Therapeutics AB
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.002 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".