eGFR Decline in Patients with IgA Nephropathy Treated with Nefecon or Placebo: Results from the 2-Year NefIgArd Phase 3 Trial
Bibliographic record
Abstract
Background: The novel targeted-release budesonide formulation Nefecon is designed to treat immunoglobulin A (IgA) nephropathy (IgAN) by downregulating IgA1 antibody production in the distal ileum. 9-month data from the first 199 patients (pts) in the Phase 3 NefIgArd trial demonstrated significant urine protein-creatinine ratio (UPCR) reduction and estimated glomerular filtration rate (eGFR) preservation with Nefecon vs placebo in pts with IgAN, as reported previously (Barratt J et al. Kidney Int 2023;103:391-402). Here, we present data for the complete study population from the full 2-year trial (9 months of treatment and 15 months of follow-up) comparing eGFR decline (measured as a confirmed 30% reduction in eGFR from baseline) in pts treated with Nefecon 16 mg/day vs placebo. Methods: Pts (≥18 years) with primary IgAN, eGFR 35-90 mL/min/1.73 m2, proteinuria ≥1 g/24 h despite renin-angiotensin system blockade, and blood pressure <140/90 mmHg, were eligible. A 30% reduction from baseline in eGFR (Chronic Kidney Disease Epidemiology Collaboration formula) was confirmed by 2 values. Results: 364 pts were included in the full analysis set. The proportion of pts with a confirmed 30% eGFR reduction was lower in the Nefecon vs placebo arm (Figure). The time to a confirmed 30% reduction was significantly delayed with Nefecon vs placebo (hazard ratio [HR] 0.45 [95% confidence interval 0.26-0.75]; p=0.0014 [1-sided]). A pre-defined supplementary analysis with rescue medication use included as an event yielded a similar result (HR 0.51). Baseline UPCR (<1.5 and ≥1.5 g/g) did not affect outcome (HR 0.51 and 0.42, respectively). Conclusions: The significantly longer time to a confirmed 30% reduction in eGFR with Nefecon vs placebo strongly indicates preserved kidney function and supports the role of Nefecon as a disease-modifying therapy. Funding: Commercial Support - Calliditas TherapeuticsFigure.: Proportion of patients with a confirmed 30% reduction in eGFR (in the absence of rescue medication) over the 2-year trial period
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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 | 0.002 |
| 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 | 0.001 | 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".