Pegcetacoplan for 52 Weeks Maintains Proteinuria Reduction Regardless of Immunosuppressant Use or Nephrotic-Range Proteinuria at Baseline: VALIANT Subgroup Analysis
Bibliographic record
Abstract
Background: Pegcetacoplan (C3/C3b inhibitor) led to significant proteinuria reduction vs placebo in C3 glomerulopathy/primary immune-complex membranoproliferative glomerulonephritis in the 26-week randomized controlled period (RCP) of VALIANT (phase 3; NCT05067127). In following 26-week open-label period (OLP), all patients received pegcetacoplan. Here, we describe responses in key patient subgroups (immunosuppressant [IS] use, baseline proteinuria) during RCP and OLP. Methods: 59 of 63 pegcetacoplan-to-pegcetacoplan and 55 of 61 placebo-to-pegcetacoplan patients completed OLP. Efficacy end points included changes from baseline in proteinuria and estimated glomerular filtration rate (eGFR). Treatment-emergent adverse events were noted. Results: Patients receiving pegcetacoplan for 52 weeks had sustained proteinuria decrease (mean [95% CI] change: week 26, –67.2% [–74.9, –57.2]; week 52, –67.2% [–75.8, –55.4]). Results were consistent with overall population regardless of IS use and baseline nephrotic proteinuria (Figure). eGFR was stable for overall pegcetacoplan-treated population (least squares mean [SE] change, mL/min/1.73 m2: week 26, –1.5 [2.2]; week 52, –3.7 [2.7]). No new safety signals were identified. Conclusion: Proteinuria reductions in RCP were maintained regardless of baseline proteinuria and IS use, confirming pegcetacoplan’s durable and consistent efficacy. eGFR was stable. Safety was consistent with previous reports.
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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) | 0.003 | 0.009 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| 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".