Prespecified Analysis of Expanded Safety Outcomes of Ravulizumab in IgAN from the SANCTUARY Trial
Bibliographic record
Abstract
Background: Ravulizumab (RAV), a complement C5 inhibitor, demonstrated clinically meaningful proteinuria reduction in the phase 2 SANCTUARY trial in IgA nephropathy (IgAN).1 Here, we report findings from a prespecified expanded safety analysis. Methods: The phase 2, double-blind, randomized, placebo-controlled trial of RAV (IV q8w) in adults with IgAN (NCT04564339) included a 26-week randomized period (RAV [n=43]; placebo [PBO; n=23]). All patients then received open-label RAV during a 24-week extension period. Patients were required to be vaccinated against meningococcal infection. Results: In the randomized period, most adverse events (AEs) were mild (90.6%; 87/96) with RAV, similar to PBO (89.3%; 67/75) (Table). There were no AEs leading to withdrawal of study drug, meningococcal infections, or deaths. The majority of AEs (86.5%; 83/96) in the randomized period were assessed as unrelated to RAV. One serious AE occurred in the RAV arm, hospitalization due to COVID-19, assessed as unrelated to intervention. Overall, the incidence of infections was similar in the RAV and PBO arms (46.5% vs 43.5% of patients). The most common infections in the RAV arm were nasopharyngitis and COVID-19 (occurring in 11.6% and 9.3%, respectively), while the most common infections in the PBO arm were influenza (8.7%) and nasopharyngitis (4.3%). There was a low incidence of infusion-related reactions, 4.7% with RAV and 8.7% with PBO, and no cases of clinically relevant immunogenicity. Safety data in the extension period were similar to the randomized period. Conclusion: RAV was well-tolerated in patients with IgAN; no unexpected safety signals were observed. The safety data are consistent with the established RAV safety profile based on >37,000 patient-years of experience including four approved indications. 1. Lafayette R, et al. J Am Soc Nephrol. 2025;36(4):645–656. Funding: Commercial Support - Alexion, AstraZeneca Rare Disease, Boston, MA, United States
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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 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| 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".