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
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.018 | 0.013 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.011 | 0.001 |
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".