Pegcetacoplan for 52 Weeks Results in Sustained Proteinuria Reduction to Remission (≤0.5 g/g) and Normalization (≤0.2 g/g): Phase 3 VALIANT Trial
Bibliographic record
Abstract
Background: Natural history studies report improved outcomes in C3 glomerulopathy (C3G) and primary immune complex-membranoproliferative glomerulonephritis (IC-MPGN) with proteinuria <0.88 or 1 g/g or proteinuria reduction ≥50%. In the 26-week randomized controlled period (RCP) of VALIANT (phase 3; NCT05067127), pegcetacoplan (C3/C3b inhibitor) led to significant proteinuria reduction vs placebo in C3G/primary IC-MPGN. In the following 26-week open-label period (OLP), all patients received pegcetacoplan. Methods: 59 of 63 pegcetacoplan-to-pegcetacoplan and 55 of 61 placebo-to-pegcetacoplan patients completed 52 weeks of treatment. Efficacy end points included proteinuria change from baseline. Results: At week 26, 20 (31.8%) pegcetacoplan-to-pegcetacoplan patients achieved complete remission (≤0.5 g/g); 11 (17.5%) achieved normalization (≤0.2 g/g) (Figure). Results were maintained at week 52. At week 52, 34 (54.0%) patients achieved ≥50% proteinuria reduction. Similar proportions of placebo-to-pegcetacoplan patients achieved remission and normalization compared to the pegcetacoplan group; 25 (41.0%) achieved ≥50% reduction. Conclusion: Proteinuria reductions to normalization/remission achieved in the RCP were maintained by patients who received pegcetacoplan for 52 weeks, confirming pegcetacoplan’s sustained efficacy. Consistent results were achieved in placebo-to-pegcetacoplan patients in the OLP.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".